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Surgical Management of Inguinal Hernia

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1 Surgical Management of Inguinal Hernia
Prepared for: Agency for Healthcare Research and Quality (AHRQ) Surgical Management of Inguinal Hernia This slide set is based on a systematic review titled Surgical Options for Inguinal Hernia: Comparative Effectiveness Review, which was developed by the ECRI Institute Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ Contract No ) and is available online at Systematic reviews are comprehensive reviews of the literature and usually compare two or more types of treatments, such as different drugs, for the same condition. This systematic review included 151 clinical studies published between January 1990 and November 2011 and sought to determine the comparative effectiveness and adverse effects of different surgical options for inguinal hernias in adults and children. There were 123 randomized controlled trials, 2 registries, and 26 studies with other designs. The primary goal of this continuing medical education activity is to examine the evidence guiding clinical treatment decisions and ultimately to aid clinicians in their care of patients with inguinal hernias. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at

2 Outline of Material Agency for Healthcare Research and Quality Comparative Effectiveness Review (CER) Process Background Clinical Questions Addressed in the CER Clinical Bottom Line: Summary of CER Results Conclusions Gaps in Knowledge Resources for Shared Decisionmaking Outline of Material The material in this continuing medical education activity covers the results and conclusions from a systematic review titled, Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. It will consist of an overview of the systematic review process used by the Agency for Healthcare Research and Quality; a background review on inguinal hernia and the available treatment options; clinically relevant questions the review sought to answer and the results; a summary of the conclusions regarding the effectiveness and adverse effects of surgical options for inguinal hernia; gaps in knowledge; and some resources for shared decisionmaking. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at

3 Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development
Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, the public, and others. A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment. The results of these reviews are summarized into a Clinician Research Summary and a Consumer Research Summary for use in decisionmaking and in discussions with patients. The Research Summaries and the full report are available at Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, the public, and others. A systematic review of all relevant clinical studies is conducted by independent researchers, who are funded by the Agency for Healthcare Research and Quality, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment. The results of these reviews are summarized into a Clinician Research Summary and a Consumer Research Summary for use in decisionmaking and in discussions with patients. The research reviews and the full report, with references for included and excluded studies, are available at Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ) AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

4 Strength of Evidence Ratings
The strength of evidence ratings are classified into four broad ratings: High High confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect. Moderate Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate. Low Low confidence that the evidence reflects the true effect. Further research is likely to change the confidence in the estimate of effect and is likely to change the estimate. Insufficient Evidence either is unavailable or does not permit a conclusion. Strength of Evidence Ratings Throughout this slide set, strength of evidence ratings are assigned to findings from analysis of primary studies. Strength of evidence is typically assigned to reviews of medical treatments after assessing four domains: risk of bias, consistency, directness, and precision. Available evidence for each intervention/comparator pair for a specific outcome was assessed for each of these four domains; the domains were combined qualitatively to develop the strength of evidence for each outcome. References Agency for Healthcare Research and Quality. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. AHRQ Publication No. 10(12)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality; April Chapters Available at Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health-Care Program. J Clin Epidemiol 2010 May;63(5): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Available at Owens DK, Lohr KN, Atkins D, et al. J Clin Epidemiol May;63(5): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

5 Background: Inguinal Hernias in Adults
An inguinal hernia is a protrusion of abdominal contents into the inguinal canal through an abdominal wall defect. Approximately 4.5 million people in the United States have an inguinal hernia. Around 500,000 new inguinal hernias are diagnosed annually. The lifetime risk of inguinal hernia is about 25 percent in males and 2 percent in females. Inguinal hernia can affect all ages, but the risk for one increases with age. Approximately 20 percent of hernia cases are bilateral. Background: Inguinal Hernias in Adults An inguinal hernia is a protrusion of abdominal contents into the inguinal canal through an abdominal wall defect. Approximately 4.5 million people in the United States have an inguinal hernia. Around 500,000 new inguinal hernias are diagnosed annually. The lifetime risk of inguinal hernia is about 25 percent in males and 2 percent in females. Inguinal hernia can affect all ages, but the risk for one increases with age. Approximately 20 percent of hernia cases are bilateral. References Abramson JH, Gofin J, Hopp C, et al. The epidemiology of inguinal hernia. A survey in western Jerusalem. J Epidemiol Community Health. 1978;32:59-67. Everhart, JE, ed. Digestive diseases in the United States: epidemiology and impact. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office, 1994; NIH publication no Goroll AH, Mulley AG. Primary care medicine: office evaluation and management of the adult patient, 5th ed. Philadelphia, Lippincott Williams & Wilkins; 2005: Nicks BA. Hernias. Medscape Reference: Drugs, Diseases, and Procedures. Last Updated June 6, Available at Accessed April 30, 2013. Rutkow IM. Epidemiologic, economic and sociologic aspects of hernia surgery in the United States in the 1990s. Surg Clin North Am. 1998;78: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Abramson JH, et al. J Epidemiol Community Health. 1978;32: Available at Everhart, JE, ed. Digestive diseases in the United States: epidemiology and impact. Washington, DC: US Government Printing Office, 1994; NIH publication no Goroll AH, et al. Primary care medicine: office evaluation and management of the adult patient, 5th ed. Philadelphia, Lippincott Williams & Wilkins; 2005: Nicks BA. Hernias. Medscape Reference: Drugs, Diseases, and Procedures. Last Updated June 6, Available at Accessed April 30, Rutkow IM. Surg Clin North Am. 1998;78: Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

6 Background: Inguinal Hernias in Children
The incidence of inguinal hernia in children ranges from 0.8 to 4.4 percent. It is 10 times as common in boys as in girls. It is more common in infants born before 32 weeks’ gestation (13% prevalence) and in infants weighing less than 1,000 grams at birth (30% prevalence). Background: Inguinal Hernias in Children In children, the incidence of inguinal hernia ranges from 0.8 to 4.4 percent. It is 10 times as common in boys as in girls. It is also more common in infants born before 32 weeks’ gestation (13% prevalence) and in infants weighing less than 1,000 grams at birth (30% prevalence). References Brandt ML. Pediatric hernias. Surg Clin North Am Feb;88(1):27-43, vii-viii. PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Brandt ML. Pediatric hernias. Surg Clin North Am Feb;88(1):27-43, vii-viii. PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

7 Direct and Indirect Inguinal Hernias
A direct inguinal hernia protrudes through the inguinal floor—defined by Hesselbach's triangle, the pubic tubercle, the lateral border of the rectus, and the inguinal ligament—and accounts for one-third of all inguinal hernias. An indirect inguinal hernia protrudes through the internal inguinal ring and may descend through the inguinal canal and accounts for about two-thirds of all inguinal hernias. Direct hernias typically develop only in adulthood and are more likely to recur than indirect hernias. Direct and Indirect Inguinal Hernias A direct inguinal hernia protrudes through the inguinal floor, defined by Hesselbach's triangle, the pubic tubercle, the lateral border of the rectus, and the inguinal ligament; whereas, an indirect inguinal hernia protrudes through the internal inguinal ring and may descend through the inguinal canal. Direct hernias typically develop only in adulthood and are more likely to recur than indirect hernias. References Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, et al. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA Jan 18;295(3): PMID: Simons MP, Aufenacker T, Bay-Nielson M, et al. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia Aug;13(4): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, et al. JAMA Jan 18;295(3): PMID: Simons MP, Aufenacker T, Bay-Nielson M, et al. Hernia Aug;13(4): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

8 Symptoms of Inguinal Hernias
If the hernia is severe enough to restrict blood supply to the intestine, it is termed a strangulated hernia; immediate corrective surgery of this type of hernia is necessary. Most inguinal hernias, however, are less dangerous, and elective surgery is often performed to correct the defect. Symptoms include abdominal pain and a lump in the groin area, which is most easily palpated during a cough. Some inguinal hernias, however, are asymptomatic and are only detected by palpation during a cough. Symptoms of Inguinal Hernias If the hernia is severe enough to restrict blood supply to the intestine, it is termed a strangulated hernia; immediate corrective surgery of this type of hernia is necessary. Most inguinal hernias, however, are less dangerous, and elective surgery is often performed to correct the defect. Symptoms include abdominal pain and a lump in the groin area, which is most easily palpated during a cough. Some inguinal hernias, however, are asymptomatic and are only detected by palpation during a cough. References Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, et al. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA Jan 18;295(3): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, et al. JAMA Jan 18;295(3): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

9 Surgical Repair of Inguinal Hernias
Surgical repair of inguinal hernias is the most commonly performed general surgical procedure in the United States. About 770,000 surgical repairs were performed in 2003. Most repairs (87%) are performed on an outpatient basis. The primary goals of surgery are to: Repair the hernia Minimize the chance of recurrence Return the patient to normal activities quickly Improve quality of life Minimize postsurgical discomfort and the adverse effects of surgery Surgical Repair of Inguinal Hernias Surgical repair of hernias is the most commonly performed general surgical procedure in the United States. In 2003, an estimated 770,000 surgical repairs of inguinal hernia were performed. These repairs are typically performed on an outpatient basis (87% in 1996). This large volume of procedures suggests that even modest improvements in patient outcomes would have a substantial impact on population health. Most inguinal hernia repairs are conducted in an outpatient setting; Rutkow (2003) estimated that 87 percent of repairs were outpatient procedures in 1996, and the percentage has probably increased since then. The primary goals of surgery are to repair the hernia, minimize the chance of recurrence, return the patient to normal activities quickly, improve quality of life, and minimize postsurgical discomfort and the adverse effects of surgery. The various surgeries present different constellations of benefits and adverse effects, which presents some clinical uncertainty in the choice among approaches. References Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in Surg Clin North Am Oct;83(5): , v-vi. PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Zhao G, Gao P, Ma B, et al. Open mesh techniques for inguinal hernia repair: a meta-analysis of randomized controlled trials. Ann Surg Jul;250(1): PMID: Rutkow IM. Surg Clin North Am Oct;83(5): , v-vi. PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at Zhao G, Gao P, Ma B, et al. Ann Surg Jul;250(1): PMID:

10 Types of Surgical Repair for Inguinal Hernias
Surgical repairs of inguinal hernia generally fall into three categories: Open repair without a mesh implant (i.e., sutured) Open repair with a mesh Laparoscopic repair with a mesh Several procedures have been employed within each of these categories. The nearly universal adoption of mesh (except in pediatric cases) means that the most relevant questions about hernia repair involve various mesh procedures. Types of Surgical Repair for Inguinal Hernias Surgical procedures for inguinal hernia repair generally fall into three categories: open repair without the use of a mesh implant (i.e., sutured), open repair with a mesh, and laparoscopic repair with a mesh. Within each of these categories, several specific procedures have been employed. Until the 1980s, open suture repair was the standard; however, the resulting tension along the suture line yielded relatively high rates of recurrence and patient discomfort. Nonsutured “tension-free” surgical mesh gained in popularity, and many specific open procedures were used. One author estimates that in 2003, 93 percent of groin hernia repairs involved the use of a mesh and about three-fourths of these repairs involved either a Lichtenstein repair or mesh plug. The nearly universal adoption of mesh means that the most relevant questions about hernia repair involve various mesh procedures. Generally, mesh is not recommended for repairing pediatric inguinal hernias for several reasons including concerns about inflammatory reactions, damage to the vas deferens and/or testes, infertility, and growth-related complications. References Brandt ML. Pediatric hernias. Surg Clin North Am Feb;88(1):27-43, vii-viii. PMID: Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in Surg Clin North Am Oct;83(5): , v-vi. PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Brandt ML. Surg Clin North Am Feb;88(1):27-43, vii-viii. PMID: Rutkow IM. Surg Clin North Am Oct;83(5): , v-vi. PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

11 Example: Open Mesh-Based Repair of an Inguinal Hernia
Before After Mesh Example: Open Mesh-Based Repair of an Inguinal Hernia The illustrations in this slide are representative of an open mesh-based repair technique wherein a mesh is placed in front of the hernia defect through an incision in the groin area.

12 Example: Laparoscopic Mesh-Based Repair of an Inguinal Hernia
Laparoscope Small cuts are made to insert the tools Example: Laparoscopic Mesh-Based Repair of an Inguinal Hernia The illustration in this slide is representative of a laparoscopic mesh-based repair technique wherein the surgeon makes small cuts near the likely hernia site and places a mesh over the affected area, either outside the peritoneum or by entering the peritoneal cavity.

13 Open Mesh-Based Repair of Inguinal Hernias (1 of 2)
Kugel® patch repair: An oval-shaped mesh is held open by a memory recoil ring and inserted behind the hernia defect and held in place with a single suture. Lichtenstein technique: A tension-free open repair wherein mesh is sutured in front of the hernia defect (anteriorly). Mesh plug technique: A preshaped mesh plug is introduced into the hernia weakness during surgery and a piece of flat mesh is put on top of the hernia. Open preperitoneal mesh technique: A tension-free repair wherein mesh is sutured posteriorly. Open Mesh-Based Repair of Inguinal Hernias (1 of 2) Kugel® patch repair*: A hernia repair procedure wherein an oval-shaped mesh that is held open by a memory recoil ring is inserted behind the hernia defect and held in place with a single absorbable suture. *The U.S. Food and Drug Administration recalled the Bard Composix® Kugel® Mesh Patch manufactured before October 2005, stating, “the mesh can break under the stress of placement inside the belly area.” Fourteen lot numbers of XenMatrix™ Surgical Graft were recalled as a result of “elevated endotoxin levels.” Lastly, 15 lot numbers of Bard® Flat Mesh were recalled because “the material was counterfeit and did not meet the manufacturer’s specifications.” Lichtenstein technique: A tension-free open hernia repair procedure wherein mesh is sutured in front of the hernia defect (anteriorly). Mesh plug technique: A hernia repair procedure wherein a preshaped mesh plug is introduced into the hernia weakness during open surgery and a piece of flat mesh is positioned on top of the hernia defect. Open preperitoneal mesh technique: A tension-free open hernia repair procedure wherein mesh is sutured posteriorly. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

14 Open Mesh-Based Repair of Inguinal Hernias (2 of 2)
PROLENE™ Hernia System: A one-piece mesh device constructed of an onlay patch connected to a circular underlay patch by a mesh cylinder. Read-Rives repair: A tension-free repair wherein mesh is placed just over the peritoneum. Stoppa technique: A large polyester mesh is interposed in the preperitoneal connective tissue between the peritoneum and the transversalis fascia to prevent visceral sac extension through the myopectineal orifice. Trabucco technique: A hernia repair procedure that involves placing a single preshaped mesh without using sutures. Open Mesh-Based Repair of Inguinal Hernias (2 of 2) PROLENE™ Hernia System (PHS): A one-piece mesh device constructed of an onlay patch connected to a circular underlay patch by a mesh cylinder. Read-Rives repair: A tension-free hernia repair procedure wherein mesh is placed just over the peritoneum. Stoppa technique: A hernia repair wherein a large polyester mesh is interposed in the preperitoneal connective tissue between the peritoneum and the transversalis fascia to prevent visceral sac extension through the myopectineal orifice. Trabucco technique: A hernia repair procedure that involves placing a single preshaped mesh without using sutures. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

15 Laparoscopic Mesh-Based Repair Procedures for Inguinal Hernias
Intraperitoneal onlay mesh technique: A mesh is placed under the hernia defect intra-abdominally to circumvent a groin dissection. Totally extraperitoneal technique: The peritoneal cavity is not entered, and a mesh is used to cover the hernia from outside the preperitoneal space. Transabdominal preperitoneal technique: A laparoscopic repair procedure wherein the surgeon enters the peritoneal cavity, incises the peritoneum, enters the preperitoneal space, and places the mesh over the hernia; the peritoneum is then sutured and tacked closed. Laparoscopic Mesh-Based Repair Procedures for Inguinal Hernias Intraperitoneal onlay mesh technique: A hernia repair procedure wherein a mesh is placed under the hernia defect intra-abdominally to circumvent a groin dissection. Totally extraperitoneal technique: A laparoscopic hernia repair procedure wherein the peritoneal cavity is not entered and a mesh is used to cover the hernia from outside the preperitoneal space. Transabdominal preperitoneal technique: A laparoscopic repair procedure wherein surgeons enter the peritoneal cavity, incise the peritoneum, enter the preperitoneal space, and place the mesh over the hernia; the peritoneum is then sutured and tacked closed. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

16 Surgical Mesh Products for Hernia Repair
Surgical mesh products are typically made from polypropylene or polyester. Other available materials include: Polytetrafluoroethylene Polyglactin Polyglycolic acid Polyamide Surgical Mesh Products for Hernia Repair Surgical mesh products for hernia repair are typically made from polypropylene (PP) or polyester. However, other materials such as polytetrafluoroethylene (PTFE), polyglactin, polyglycolic acid, and polyamide are also used. One reason a surgeon may debate the use of one mesh versus another is the mechanical support the mesh is reported to provide the deficient abdominal wall. PP mesh has been the standard material against which other materials are compared. According to Robinson and colleagues (2005), an advantage of PP is that infections can be treated without mandatory removal of the mesh, while other materials such as PTFE may require removal. Biologic mesh materials such as porcine are decellularized living tissues composed of a collagen matrix. Two theoretical concerns for the use of biologic materials for hernia repair include potential transmission of diseases and the reduction in tensile strength of the mesh. References Mohamed H, Ion D, Serban MB, et al. Selecting criteria for the right prosthesis in defect of the abdominal wall surgery. J Med Life Jul-Sep;2(3): PMID: Robinson TN, Clarke JH, Schoen J, et al. Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Surg Endosc Dec;19(12): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Mohamed H, Ion D, Serban MB, et al. J Med Life Jul-Sep;2(3): PMID: Robinson TN, Clarke JH, Schoen J, et al. Surg Endosc Dec;19(12): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

17 Properties of Mesh Products for Hernia Repair
Seven important properties of mesh are: Withstands physiologic stresses over time Conforms to the abdominal wall Mimics normal tissue healing Resists the formation of bowel adhesions and erosions into visceral structures Does not induce allergic reaction or foreign body reactions Resists infection Is noncarcinogenic Properties of Mesh Products for Hernia Repair Mohamed and colleagues (2009) listed seven important properties of the ideal mesh. It: 1. Is strong enough to withstand physiologic stresses over a long period of time 2. Conforms to the abdominal wall 3. Promotes strong host tissue in-growth, which mimics normal tissue healing 4. Resists the formation of bowel adhesions and erosions into visceral structures 5. Does not induce allergic reaction or adverse foreign body reactions 6. Resists infection 7. Is noncarcinogenic References Mohamed H, Ion D, Serban MB, et al. Selecting criteria for the right prosthesis in defect of the abdominal wall surgery. J Med Life Jul-Sep;2(3): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Mohamed H, Ion D, Serban MB, et al. J Med Life Jul-Sep;2(3): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

18 Clinical Questions Addressed in the Comparative Effectiveness Review
What is the comparative effectiveness of: Laparoscopic versus open repair in adults with painful hernia (primary, bilateral, and recurrent hernia)? Different types of repair for the pediatric population? Surgery versus watchful waiting in adults with a pain-free or minimally symptomatic inguinal hernia? Different types of open surgery? Different types of laparoscopic surgery? Different mesh materials? Different mesh-fixation approaches? Is there an association between surgical experience and hernia recurrence? Clinical Questions Addressed in the Comparative Effectiveness Review The objective of the comparative effectiveness review was to summarize the evidence regarding the safety and effectiveness of surgical interventions for inguinal hernia. To this end, this continuing medical education activity will summarize the effectiveness and adverse effects of open repair versus laparoscopic repair of primary, bilateral, or recurrent hernias; repair of pediatric hernias; surgery versus watchful waiting for a pain-free or minimally symptomatic inguinal hernia; different open repair procedures; different laparoscopic repair procedures; various mesh materials; various mesh-fixation approaches; and the evidence regarding an association between surgical experience and recurrence rates. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

19 Outcomes of Interest Outcomes Adverse effects Hernia recurrence
Hospital-related information (length of hospital stay and hospital/office visits) Return to daily activities Return to work Quality of life Patient satisfaction Short-term pain (≤1 month after surgery) Intermediate-term pain (>1 and <6 months after surgery) Long-term pain (≥6 months after surgery) Adverse effects Infection Perception of a foreign body Small-bowel perforation/obstruction Hematoma Epigastric vessel injury Urinary retention Spermatic cord injury Outcomes of Interest The outcomes of interest for the comparative effectiveness review titled Surgical Options for Inguinal Hernia: Comparative Effectiveness Review include hernia recurrence, hospital-related information (length of hospital stay and hospital/office visits), return to daily activities, return to work, quality of life, patient satisfaction, and short-term pain (≤1 month after surgery), intermediate-term pain (>1 and <6 months after surgery), and long-term pain (≥6 months after surgery). The adverse effects of interest include infection, perception of a foreign body, small-bowel perforation/obstruction, hematoma, epigastric vessel injury, urinary retention, and spermatic cord injury. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

20 Results: Overview of the Patient Population
The typical adult in the studies included in this review was: A man in his mid 50s Who was of average weight (median body mass index of 25.3 kg/m2; interquartile rage of 25.0–26.7) Who had an elective repair of a primary unilateral inguinal hernia About a quarter of the men worked in physically strenuous jobs; for these men, a durable repair is important to prevent a recurrence. Results: Overview of the Patient Population The relevant patient population in the included studies was a male adult in his mid 50s with a median body mass index of 25.3 kg/m2 (interquartile range of 25.0–26.7) and who had an elective repair of a primary unilateral inguinal hernia. About a quarter of the men worked in physically strenuous jobs; for these men, a durable repair is important to prevent a recurrence. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

21 Results: Overview of Studies Included in the Comparative Effectiveness Review
Total included studies: N = 151 Open versus laparoscopic repair in adults: Primary hernias; n = 38 Bilateral hernias; n = 6 Recurrent hernias; n = 8 Open versus laparoscopic high ligation for pediatric hernias; n = 2 Repair versus watchful waiting in adults with pain-free hernias; n = 2 Open mesh-based procedures; n = 21 Laparoscopic procedures; n = 11 Mesh materials; n = 32 Fixation methods; n = 23 Surgical experience and hernia recurrence; n = 32 Results: Overview of Studies Included in the Comparative Effectiveness Review This slide describes the number of studies that were included in the comparative effectiveness review for each comparison shown. The number of studies in each analysis adds up to more than the number of total included studies because some studies were included for multiple comparisons. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ) AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

22 Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults—Included Studies Thirty-eight studies met the inclusion criteria. The most commonly compared procedures include: TAPP repair versus Lichtenstein (n = 14) TEP repair versus Lichtenstein (n = 14) TAPP repair versus mesh plug (n = 3) TEP repair versus mesh plug (n = 3) TAPP repair/TEP repair versus Lichtenstein (n = 4) Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults—Included Studies Thirty-eight studies met the inclusion criteria. The most commonly compared surgical procedures were transabdominal preperitoneal (TAPP) repair versus Lichtenstein (14 studies), totally extraperitoneal (TEP) repair versus Lichtenstein (14 studies), TAPP repair versus mesh plug (3 studies), TEP repair versus mesh plug (3 studies), and TAPP repair/TEP repair versus Lichtenstein (4 studies). All but two studies (which were registry studies) were considered to have moderate risk of bias. These outcomes were considered to be major: hernia recurrence, length of hospital stay, return to daily activity, return to work, quality of life, patient satisfaction, long-term pain, epigastric vessel injury, small-bowel injury, small-bowel obstruction, urinary retention, hematoma, and wound infection. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Abbreviations: TAPP = transabdominal preperitoneal; TEP = totally extraperitoneal Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

23 Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults (1 of 2)
Outcome Surgery Favored Calculated Differences (95% CI) SOE Hernia recurrence Open surgery RR = 1.43 (1.15 to 1.79); 2.49% recurrence after open versus 4.46% recurrence after laparoscopy Low Length of hospital stay Approximate equivalence Summary difference in means = -0.33 days (-0.52 to -0.14) Return to normal daily activities Laparoscopic SWMD in days = -3.9 (-5.6 to -2.2) High Return to work SWMD in days = -4.6 (-6.1 to -3.1) Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults (1 of 2) Hernia Recurrence Thirty of the 38 studies were included in a meta-analysis that found that recurrence is more likely after laparoscopic surgery than after open surgery (summary relative risk [RR] = 1.43; 95-percent confidence interval [95% CI], 1.15 to 1.79). The minimum clinically significant difference (MCSD) was defined as a 3-percentage-point difference between groups. To aid interpretation, the overall rate of recurrence in the open repair groups was calculated and found to be 2.49 percent. Multiplying a 1.79 RR by this rate yields a corresponding rate of 4.46 percent for laparoscopy. The difference between these rates is only 1.97 percent, which is less than the predefined MCSD of 3 percentage points. This implies that the difference between open repair and laparoscopy, while statistically significant, is not substantial. This outcome has a low strength of evidence. Length of Hospital Stay Seventeen of the 38 studies could be included in a meta-analysis of the length of stay in days and found that length of stay is shorter after laparoscopic surgery than after open surgery (summary weighted mean difference [SWMD] = 0.33 days; 95% CI, 0.52 to 0.14). This is only about an 8-hour difference (i.e., a third of a day), which is less than the predefined MCSD of 1 day. Return to Daily Activities Fifteen of the 38 studies were included in a meta-analysis that found that the return to normal daily activities is shorter after laparoscopic surgery than after open surgery (SWMD = 3.9 days; 95% CI, 5.6 to -2.2). This is larger than the predefined MCSD for this outcome of 1 day. Return to Work Nineteen of 38 studies were combined in a meta-analysis that indicated shorter time to return to work after laparoscopic repair (SWMD = 4.6 days; 95% CI, 6.1 to 3.1). This is larger than the predefined MCSD for this outcome of 1 day. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Abbreviations: 95% CI = 95-percent confidence interval; RR = relative risk; SOE = strength of evidence; SWMD = summary weighted mean difference Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

24 Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults (2 of 2)
Outcome Surgery Favored Calculated Differences (95% CI) SOE Long-term pain Laparoscopic OR = 0.61 (0.48 to 0.78) Moderate Epigastric vessel injury Open OR = 2.1 (1.1 to 3.9) Low Hematoma OR = 0.70 (0.55 to 0.88) Wound infection OR = 0.49 (0.33 to 0.71) Abbreviations: 95% CI = 95-percent confidence interval; OR = odds ration; SOE = strength of evidence Clinical Bottom Line: Laparoscopic Versus Open Repair of Painful Primary Hernias in Adults (2 of 2) Long-Term Pain Thirteen studies reporting long-term pain (>6 months after surgery) were included in a meta-analysis that found moderate-strength evidence that there is a lower rate of long-term pain after laparoscopic surgery than after open surgery (odds ratio [OR] = 0.61; 95-percent confidence interval [95% CI], 0.48 to 0.78). The severity of the pain may not have differed substantially between treatments. Two of the 14 studies measured the degree of pain severity in the long term. One study found that at 2 years, the between-group difference in pain at rest is no more than 3.5 millimeters, which corresponds to only 2.3 percent of the 150-millimeter scale range. The other study reported pain severity at both 6 months and 1 year; patients receiving laparoscopy had less pain severity, and the difference was about 0.7 points on a 0–10 scale (7% of the scale range). Adverse Effects A meta-analysis was conducted of six types of adverse effects—epigastric vessel injury reported in 10 studies, hematoma reported in 25 studies, small-bowel injury reported in 4 studies, small-bowel obstruction reported in 7 studies, urinary retention reported in 20 studies, and wound infection reported in 18 studies. The evidence on small-bowel injury, small-bowel obstruction, urinary retention, and spermatic cord injury were inconclusive. A clear direction of effect was found for three events: epigastric vessel injury (higher rates with laparoscopic repair; OR = 2.1; 95% CI, 1.1 to 3.9; low strength of evidence), hematoma (lower rates with laparoscopic repair; OR = 0.70; 95% CI, 0.55 to 0.88; low strength of evidence), and wound infection (lower rates with laparoscopic repair; OR = 0.49; 95% CI, 0.33 to 0.71; moderate strength of evidence). Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

25 Clinical Bottom Line: Surgical Repair of Bilateral Hernias
Patients with bilateral hernias return to work about 2 weeks sooner after laparoscopic (TAPP or TEP) repair versus open (Lichtenstein or Stoppa) repair. Strength of Evidence = Low Evidence was inconclusive for all other outcomes and adverse effects for laparoscopic versus open repair of bilateral hernias. Abbreviations: TAPP = transabdominal preperitoneal; TEP = totally extraperitoneal Clinical Bottom Line: Surgical Repair of Bilateral Hernias Six studies were included in this analysis. Three studies compared totally extraperitoneal (TEP) repair to the Stoppa procedure, two compared transabdominal preperitoneal (TAPP) repair to Lichtenstein, and one study compared TAPP/TEP to Lichtenstein. The meta-analyses for these outcomes were inconclusive: hernia recurrence, length of hospital stay, return to daily activities, and adverse effects. No studies that addressed quality of life, patient satisfaction, or long-term pain were included. Return to Work Only one of the six studies reported data on return to work, and low-strength evidence suggests that there is a much shorter return to work after laparoscopy (median 16 days) than after open surgery (median 30 days; p < 0.05). Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at http;//www.effectivehealthcare.ahrq.gov/inguinal-hernia.cfm Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

26 Clinical Bottom Line: Laparoscopic Versus Open Repair of Recurrent Hernias
Outcome Surgery Favored Results (95% CI) SOE Return to daily activities Laparoscopic SWMD = -7.4 days (-11.4 to ) High Long-term pain OR = 0.24 (0.08 to 0.74) Moderate Re-recurrence rates Laparoscopic (TAPP or TEP) RR = 0.82 (0.70 to 0.96); 7.5% for laparoscopic vs. 12.3% for open repair Low Abbreviations: 95% CI = 95-percent confidence interval; OR = odds ratio; RR = relative risk; SOE = strength of evidence; SWMD = summary weighted mean difference; TAPP = transabdominal preperitoneal; TEP = totally extraperitoneal Clinical Bottom Line: Laparoscopic Versus Open Repair of Recurrent Hernias Eight studies were included in this analysis. The Lichtenstein open mesh procedure was used in six studies, and the Stoppa procedure was used in the other two studies. For the laparoscopic mesh procedure, transabdominal preperitoneal (TAPP) repair was used in two studies, totally extraperitoneal (TEP) repair was used in two studies, both repairs were used in one study that reported data separately, and both TAPP and TEP repairs were used in three studies that combined the data. The meta-analysis for return to daily activities indicated an advantage of laparoscopic repair (summary weighted mean difference [SWMD] = 7.4 days; 95-percent confidence interval [95% CI], 11.4 to 3.4; high strength of evidence). The meta-analysis for long-term pain indicated lower rates of long-term pain after laparoscopy (odds ratio [OR] = 0.24; 95% CI, 0.08 to 0.74; moderate strength of evidence). This finding indicates a clinically significant difference in rates. The severity of pain is unclear, however, because none of the included studies measured long-term pain on a continuous scale. Given that this question addresses patients who are undergoing surgery for recurrent hernia, this outcome is technically hernia re-recurrence. A meta-analysis of these data favored laparoscopic repair over open repair (summary relative risk [RR] 0.76; 95% CI, 0.60 to 0.98). The length of followup varied widely across the studies, with one study following patients from 0–3 years and another following patients for an average of 5.3 years. The minimum clinically significant difference (MCSD) for recurrence was 3 percentage points. To aid interpretation of the summary RR of 0.76, the overall rate of re-recurrence was calculated in the open repair groups and found to be 12.5 percent. Applying an RR of 0.76 to this rate yields a laparoscopic re-recurrence rate of 9.5 percent; applying it to the lower bound of RR = 0.60 yields a lower percentage of 7.5; applying it to the upper bound of RR = 0.98 yields an upper bound of 12.3 percent. Thus the difference in percentages could be as high as 4.8 percent (range of 12.3% to 7.5%), which is higher than the MCSD of 3 percentage points. Thus, it is unclear whether the advantage of laparoscopy for preventing re-recurrence can be considered clinically significant. Meta-analyses were inconclusive for return to work (SWMD = 6.4 days; 95% CI, 13.2 to +0.34), length of hospital stay (SWMD = 1.3 days; 95% CI, 2.8 to +0.33), and all reported adverse effects including epigastric vessel injury, hematoma, urinary retention, and wound infection. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

27 Open Versus Laparoscopic High Ligation for Pediatric Hernias (Ages 3 Months to 15 Years)
Laparoscopic repair is favored for three outcomes, although some of the differences may not be clinically relevant: Long-term overall patient/parent satisfaction (difference in satisfaction points = 1.00; 95% CI, 0.47 to 1.53) Strength of Evidence: Low Length of hospital stay (summary difference = 1 hour; 95% CI, 0.5 to 1.8) Strength of Evidence: Moderate Long-term cosmesis (difference in satisfaction points = 0.25; 95% CI, 0.12 to 0.38) Strength of Evidence: Low The time to return to daily activities was equivalent. Strength of Evidence: Low Open Versus Laparoscopic High Ligation for Pediatric Hernias (Ages 3 Months to 15 Years) Two studies met the inclusion criteria for this analysis. One study enrolled patients aged 4 months to 16 years; the other study enrolled patients aged 3 months to 9 years. Both studies were considered to have moderate risk of bias. Neither study included very young patients. The study by Chan et al. (2005) excluded patients younger than 3 months, and the study by Koivusalo et al. (2009) excluded patients younger than 4 months. Both studies excluded patients with an incarcerated or a strangulated hernia. The findings of the studies may not apply to the patient populations being excluded. Long-Term Patient Satisfaction One study reported long-term overall patient or parent satisfaction. Patient satisfaction was recorded (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by patients or parents, the attending nurse, and the surgeon (minimum points = 0, maximum points = 9). The parents were more satisfied (difference in satisfaction points = 1; 95-percent confidence interval [95% CI], 0.47 to 1.53) in the laparoscopic group when compared with the open group. This result was rated as having low strength of evidence. Length of Hospital Stay Both studies reported an outcome in length of hospital stay and were included in a meta-analysis. The meta-analysis found that length of stay was shorter after laparoscopic surgery than after open surgery (summary difference = 1.13 hours; 95% CI, 1.77 to 0.49; moderate strength of evidence). Given that the confidence interval included values of less than 1 (the predefined minimum clinically significant difference) as well as values above 1, the clinical significance of this finding remains unclear. Long-Term Cosmesis One study was included in this analysis. Cosmesis was recorded (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by patients or parents, the attending nurse, and the surgeon (minimum points = 0, maximum points = 9). The parents in the laparoscopic group were more content with cosmesis than those in the open group (difference in satisfaction points = 0.25; 95% CI, 0.12 to 0.38; low strength of evidence). Return to Daily Activities Both studies were included in a meta-analysis of number of hours before returning to normal daily activities. The result of the meta-analysis was equivalent (summary difference = 2.77 hours; 95% CI, 11.24 to 5.69; low strength of evidence). References Chan KL, Hui WC, Tam PK. Prospective randomized single-center, single-blind comparison of laparoscopic vs open repair of pediatric inguinal hernia. Surg Endosc Jul;19(7): PMID: Koivusalo AI, Korpela R, Wirtavuori K, et al. A single-blinded, randomized comparison of laparoscopic versus open hernia repair in children. Pediatrics Jan;123(1): PMID: Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Chan KL, Hui WC, Tam PK. Surg Endosc Jul;19(7): PMID:  Koivusalo AI, Korpela R, Wirtavuori K, et al. Pediatrics Jan;123(1): PMID:  Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

28 Clinical Bottom Line: Pain-Free Primary Hernias—Repair Versus Watchful Waiting in Adults
Mesh repair may improve a patient’s overall health status at 12 months more than watchful waiting (difference in mean SF-36 scores = 7.3; 95% CI, 0.4 to 14.3). Low strength of evidence There is not enough information to know if there are differences in adverse effects. Clinical Bottom Line: Pain-Free Primary Hernias—Repair Versus Watchful Waiting in Adults Two randomized controlled trials were included in the analysis of repair versus watchful waiting in adults with pain-free or minimally symptomatic inguinal hernias. Together, these trials included 877 patients, and the length of followup ranged from 1–4 years. The two studies enrolled patients aged >18 and >55 years of age, respectively. The mean age of the patients ranged from 57.5 to 71.9 years; most patients were male with primary hernias. One compared watchful waiting with Lichtenstein repair, and the other compared watchful waiting with a “tension-free mesh repair.” Both studies were considered to have moderate risk of bias for all outcomes reported. There were no studies of laparoscopic repair versus watchful waiting for a pain-free hernia. Furthermore, the available comparative studies in the adult population did not report long-term outcomes that could be useful for decisionmaking, such as the risk of an eventual acute presentation (e.g., strangulation, incarceration) in an unrepaired pain-free hernia, the likelihood of recurrence for a repaired pain-free hernia, or the likelihood of developing pain or impairment in function in the long term with either repair or watchful waiting. It is unclear how these results apply to women or to men of other age groups. Quality of Life One study reported quality-of-life data on an intention-to-treat basis using the SF-36 instrument. At 6 months, the surgical group fared better than the watchful waiting group on “general health” (mean group difference = 5.8; 95-percent confidence interval [95% CI], 0.1 to 11.5) and “overall change in health status in the previous 12 months” (mean group difference = 9.4; 95% CI, 3.6 to 15.1). At 12 months, the surgical group still fared better than the watchful waiting group on “overall change in health status in the previous 12 months” (mean group difference = 7.3; 95% CI, 0.4 to 14.3; p = 0.039). There were no statistically significant differences on other SF-36 items at both 6 and 12 months. Long-Term Pain The two studies used different measures for comparing long-term pain (>6 months after surgery). One study reported group differences at 2 years for pain interfering with activities among the intention-to-treat patients. In an intention-to-treat analysis, the percentage of patients with pain among the surgical group was 2.2 compared with 5.1 in the watchful waiting group. This difference was not statistically significant (odds ratio = 0.42; 95% CI, 0.17 to 1.04) and did not indicate equivalence. The second study compared the pain (measured with a visual analogue scale [VAS]) scores at rest and at movement between the two groups. They reported no statistically significant difference in mean pain (measured with a VAS) scores at rest (difference in means = 1.5; 95% CI, 4.8 to 1.8) and during movement (difference in means = 1.5; 95% CI, 6.1 to 2.3) at 12 months. The low precision precludes any conclusion for this outcome. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

29 Comparative Effectiveness of Open Mesh-Based Repair Procedures
Twenty-one studies were included. The most commonly compared procedures were: Lichtenstein versus mesh plug (n = 7) Lichtenstein versus the PROLENE™ Hernia System (PHS; n = 5) Lichtenstein versus the open preperitoneal mesh technique (n = 3) Mesh plug versus the PHS (n = 2) Lichtenstein versus the Kugel® Mesh Patch (n = 2) Studies were typically conducted between 2000 and 2010. Comparative Effectiveness of Open Mesh-Based Repair Procedures Twenty-one studies were included in this analysis. The most commonly compared procedures were Lichtenstein versus mesh plug (7 studies), Lichtenstein versus the PROLENE™ Hernia System (PHS; 5 studies), Lichtenstein versus the open preperitoneal mesh technique (3 studies), mesh plug versus the PHS (2 studies), and Lichtenstein versus the Kugel® Mesh Patch (2 studies). The randomized controlled trials enrolled between 26 and 597 patients each, and the Swedish registry included 142,578 hernias repaired in that country. The dates of patient enrollment were reported in 14 of 21 studies. The average length of the enrollment period was 3.5 years (range of 9 months to 14 years). Studies were typically conducted between 2000 and 2010. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

30 Comparative Effectiveness of Open Mesh-Based Repair Procedures—Lichtenstein Versus Mesh Plug
Rates of recurrence were approximately equivalent. Strength of Evidence: Moderate Patients who have the Lichtenstein repair may return to work about 4 days earlier (95% CI, 1 to 7). Strength of Evidence: Moderate Lichtenstein repair is associated with lower rates of seroma than mesh plug repair (OR = 0.39; 95% CI 0.16 to 0.94). Strength of Evidence: Moderate Comparative Effectiveness of Open Mesh-Based Repair Procedures—Lichtenstein Versus Mesh Plug Seven studies on Lichtenstein versus mesh plug repair were included in this analysis. Hernia Recurrence A meta-analysis of three studies was conducted for this outcome and identified a summary relative risk (RR) of 1.07 (95-percent confidence interval [95% CI], 0.33 to 3.42). The length of followup in the three studies was 1 year, 1.7 years, and 3 years, respectively. The minimum clinically significant difference (MCSD) was defined as a 3-percentage-point difference between groups to aid interpretation; the overall rate of recurrence in the Lichtenstein group was calculated and found to be 1.07 percent. Multiplying a 3.42 RR with this rate yielded a corresponding rate of 3.67 percent for the group treated with a light-weight polypropylene mesh. The difference between these rates is only 2.59 percent, which is less than the predefined MCSD of 3 percentage points. This suggests, with moderate-strength evidence, that recurrence rates are approximately equivalent. Return to Work Two studies reported return-to-work data and were combined in a meta-analysis that indicated a shorter time to return to work after Lichtenstein repair (summary difference in means = 4.0; 95% CI, 6.97 to 1.02; moderate strength of evidence). This time is larger than the predefined MCSD of 1 day for this outcome. Adverse Events A meta-analysis of four types of adverse effects (seroma reported in three studies, hematoma reported in five studies, wound infection reported in five studies, and urinary retention reported in two studies) was conducted. A clear direction of effect was found for one event: seroma (lower rates with Lichtenstein repair; odds ratio = 0.39; 95% CI, 0.16 to 0.94; moderate strength of evidence). For the other three events, the evidence was inconclusive. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

31 Comparative Effectiveness of Other Open Mesh-Based Repair Procedures
Short-term pain outcomes were similar for these open repair procedures: Mesh plug versus the PROLENE™ Hernia System (PHS) Strength of Evidence: Moderate Lichtenstein versus the PHS Strength of Evidence: Moderate Lichtenstein versus open preperitoneal mesh Strength of Evidence: Low Lichtenstein versus the Kugel® Mesh Patch Strength of Evidence: Low Intermediate-term pain was also similar for Lichtenstein versus Kugel Mesh Patch repair. Strength of Evidence: Low Comparative Effectiveness of Other Open Mesh-Based Repair Procedures For the remaining comparisons of open repair procedures, short-term pain outcomes were found to be similar for mesh plug versus the PROLENE™ Hernia System (PHS; moderate strength of evidence), Lichtenstein versus the PHS (moderate strength of evidence), Lichtenstein versus open peritoneal mesh (low strength of evidence), and Lichtenstein versus the Kugel® Mesh Patch (low strength of evidence). Intermediate-term pain was also similar for Lichtenstein versus Kugel Mesh Patch repair (low strength of evidence). The evidence for all other outcomes and adverse effects were either not available or did not permit a conclusion. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

32 Comparative Effectiveness of Laparoscopic Repair Procedures—TAPP Versus TEP
Transabdominal preperitoneal (TAPP) repair may offer a 1.4-day earlier return to work; however, this may not be clinically significant. Strength of Evidence: Moderate Short-term pain outcomes were similar. Strength of Evidence: Moderate Intermediate-term and long-term pain outcomes were similar. Strength of Evidence: Low Research on comparative adverse effects between TAPP and totally extraperitoneal repairs was inconclusive for hematoma, urinary retention, and wound infection. Comparative Effectiveness of Laparoscopic Repair Procedures—TAPP Versus TEP Eleven studies were included in the comparisons among laparoscopic repair procedures. Nine of these studies compared transabdominal preperitoneal (TAPP) versus totally extraperitoneal (TEP) repair. The other two studies compared different variants of surgical approaches for TEP or TEP versus intraperitoneal onlay mesh. For the nine studies comparing TAPP versus TEP repair, evidence was inconclusive for hernia recurrence, length of hospital stay, return to daily activities, and adverse effects including hematoma, urinary retention, and wound infection. Return to Work Four studies reported return-to-work data, and three were combined in a meta-analysis. A fourth study that reported outcome data as return to “unrestricted” work was not included in the meta-analysis. The meta-analysis indicated a shorter time to return to work after TAPP repair (summary difference in means = 1.44 days; 95-percent confidence interval [95% CI], 2.65 to 0.23; moderate strength of evidence). The 95% CI spans the predefined minimum clinically significant difference for this outcome of 1 day. Therefore, it is unclear whether the difference found is clinically significant. Short-Term Pain Five studies reporting short-term pain (1 month or less after surgery) measured with a visual analogue scale (VAS) were included in a meta-analysis. This analysis found approximately equivalent rates of short-term pain (summary difference in means: 0.11; 95% CI, 0.25 to 0.03 points on a 0–10 scale; moderate strength of evidence). Intermediate-Term Pain Only one study reported data on this outcome at 3 months, and the results suggested equivalence on the 0–10 VAS scale ( in the TAPP group vs in the TEP group; low strength of evidence). Long-Term Pain Only one study reported data on this outcome at 38 months, and the results suggested equivalence on the 0–10 VAS scale (none in the TAPP group vs. none in the TEP group; low strength of evidence). Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

33 Comparative Effectiveness of Mesh Materials
Hernia recurrence occurred at similar rates with polypropylene mesh versus combination materials.* Strength of Evidence: Moderate Long-term pain after surgery was similar for standard polypropylene mesh when compared with biologic mesh or light-weight polypropylene mesh. Strength of Evidence: Low Evidence on comparative adverse effects for the different types of mesh materials was inconclusive. *Descriptions of the combination-material mesh analyzed for this outcome can be found in the full report. Comparative Effectiveness of Mesh Materials Thirty-two studies met the inclusion criteria. For this Key Question, the following seven comparisons were considered to be major: standard polypropylene (PP) versus light-weight PP (6 studies), standard PP versus combination materials (17 studies), standard PP versus coated PP (6 studies), standard PP versus the three-dimensional PROLENE™ Hernia System (2 studies), standard PP versus biologic mesh (2 studies), combination materials versus biologic mesh (1 study), and light-weight PP versus combination materials (3 studies). Complete descriptions of the combination-material mesh analyzed for this outcome can be found in the full report. Most evidence was considered to have moderate risk of bias. The following seven outcomes were considered to be major: hernia recurrence, quality of life, patient satisfaction, long-term pain, perception of a foreign body, infection, and bleeding. Standard PP mesh and combination materials had similar rates of recurrence. Three types of meshes—standard PP, light-weight PP, and biologic mesh—had approximately equivalent rates of long-term pain. The evidence on the adverse effects of perceiving a foreign body (4 studies) and infection (5 studies) were too imprecise to permit a conclusion. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

34 Comparative Effectiveness of Fixation Methods
After laparoscopic surgery, hernia recurrence rates were similar for tacks or staples versus no fixation. Strength of Evidence: Moderate Mesh fixed with sutures versus glue during open or laparoscopic surgery had similar: Recurrence rates Strength of Evidence: Moderate Long-term pain outcomes Strength of Evidence: Low Mesh fixed with fibrin glue during transabdominal preperitoneal repair resulted in less long-term pain than when the mesh was fixed with staples. Strength of Evidence: Moderate Data on adverse effects were either missing or inconclusive. Comparative Effectiveness of Fixation Methods Twenty-three studies met the inclusion criteria. These five comparisons were considered to be major: tacks or staples versus no fixation (7 studies), fibrin glue versus staples (3 studies), sutures versus tacks (3 studies), sutures versus glue (7 studies), and absorbable sutures (short-term or long-term) versus nonabsorbable sutures (1 study). Most studies were considered to have moderate risk of bias. Approximate equivalence was found in recurrence rates for tacks or staples versus no fixation after laparoscopic surgery. When mesh was fixed with sutures versus glue during an open repair or a laparoscopic repair, approximate equivalence was seen in recurrence rates and in long-term pain outcomes. Mesh fixed with fibrin glue during transabdominal preperitoneal repair resulted in less long-term pain than when the mesh was fixed with staples. Evidence on other comparisons and adverse effects were either missing or inconclusive. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

35 Association Between Laparoscopic Surgical Experience and Hernia Recurrence
Thirty-two studies reported on this association. The length of the learning curve for TEP or TAPP repair could not be estimated due to problems associated with not accounting for followup time, not accounting for the evolution of procedures over time, and selective outcome reporting. Generally, the risk of recurrence decreases when a more experienced surgeon performs a repair, but there were not enough congruent studies to perform a meta-analysis. Abbreviations: TAPP = transabdominal preperitoneal; TEP = totally extraperitoneal Association Between Laparoscopic Surgical Experience and Hernia Recurrence Generally, the risk of recurrence decreases when a more experienced surgeon performs a repair, but there were not enough congruent studies to perform a meta-analysis. This section found a large amount of evidence reporting that greater surgical experience with laparoscopic herniorrhaphy is associated with lower recurrence rates. The variations in reporting, however, made it impossible to estimate the length of the learning curve. Problems arose in interpreting the data in three areas: the possibility of a time confound (that earlier patients had been followed for longer periods and had more time to have recurrences), procedural evolutions (that details of the procedure often changed over time making it difficult to pinpoint the effect of expertise), and selective outcome reporting (that the studies reporting this association may have chosen to do so because of the nature of the data). Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

36 Conclusions: Patient Population
The typical adult in the studies included in this review was a man in his mid 50s, of average weight (median body mass index, 25.3 kg/m2; interquartile range, 25.0–26.7), who had an elective repair of a primary unilateral inguinal hernia. It is unclear how these results apply to: Women Men of other age groups About a quarter of the men with hernias worked in physically strenuous jobs; for these men, a durable repair is important to prevent a recurrence. Conclusions: Patient Population The typical adult in the studies included in this review was a man in his mid 50s, of average weight (median body mass index, 25.3 kg/m2; interquartile range, 25.0–26.7), who had an elective repair of a primary unilateral inguinal hernia. It is unclear how these results apply to women. It is also unclear how these results apply to men of other age groups. About a quarter of the men worked in physically strenuous jobs; for these men, a durable repair is important to prevent a recurrence. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

37 Conclusions: Laparoscopic Versus Open Repair of Inguinal Hernias in Adults
Laparoscopic repair of an inguinal hernia is associated with: Faster recovery times Less risk of long-term pain A lower risk of another hernia recurrence after a previous recurrence Open hernia repair may be associated with: Fewer internal injuries Lower recurrence rates in the context of primary inguinal hernia Conclusions: Laparoscopic Versus Open Repair of Inguinal Hernias in Adults Results indicate that laparoscopic repair of an inguinal hernia is associated with faster recovery times and less risk of long-term pain; for recurrent hernias, it may also lower the risk of another hernia recurrence. Open hernia repair, however, is familiar to more surgeons. Such repair may be associated with fewer internal injuries and may have lower recurrence rates in the context of a primary inguinal hernia. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

38 Conclusions: Watchful Waiting Versus Repair for Pain-Free Inguinal Hernias
Low-strength evidence suggests that choosing to repair a pain-free hernia with a Lichtenstein or tension-free mesh repair over watchful waiting may improve quality of life. However, this finding may not be applicable to other types of repair procedures (e.g., laparoscopic repair). The evidence on adverse effects was inconclusive. Conclusions: Watchful Waiting Versus Repair for Pain-Free Inguinal Hernias Low-strength evidence suggests that choosing to repair a pain-free or minimally symptomatic inguinal hernia with a Lichtenstein or tension-free mesh repair over watchful waiting may improve quality of life; however, this may not be applicable to other types of repair procedures. The evidence on adverse effects was inconclusive. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

39 Conclusions: Mesh Material and Fixation Methods
Research found most of the meshes or fixation methods to be equivalent in their effectiveness and risk of adverse effects with only a few exceptions. Conclusions: Mesh Material and Fixation Methods Research found most of the meshes or fixation methods to be equivalent in their effectiveness and risk of adverse effects with only a few exceptions. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

40 Gaps in Knowledge How the surgeon's experience influences surgical outcomes such as recurrence and pain The comparative effectiveness and adverse effects of laparoscopic repair versus watchful waiting for pain-free or minimally symptomatic inguinal hernias in adults The comparative effectiveness and adverse effects of contralateral exploration/repair versus watchful waiting in the pediatric population More evidence on several outcomes related to the comparisons of mesh products and fixation methods including recurrence rates, perception of a foreign body, long-term pain, and infection rates Clarification in future studies of whether the population includes emergent as well as elective surgeries and whether or not the findings apply equally to both populations Gaps in Knowledge In the course of conducting this review, several gaps in the evidence were identified. These gaps may serve as useful potential areas of future research. How the surgeon's experience influences surgical outcomes such as recurrence and pain The comparative effectiveness and adverse effects of laparoscopic repair versus watchful waiting for pain-free or minimally symptomatic inguinal hernias in adults The comparative effectiveness and adverse effects of contralateral exploration/repair versus watchful waiting in the pediatric population More evidence on several outcomes related to the comparisons of mesh products and fixation methods including recurrence rates, perception of a foreign body, and long-term pain and infection rates Clarification in future studies of whether the population includes emergent as well as elective surgeries and whether or not the findings apply equally to both populations Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at Treadwell J, Tipton K, Oyesanmi O, et al. AHRQ Comparative Effectiveness Review No. 70. Available at

41 Shared Decisionmaking: What To Discuss With Your Patients
If repair or watchful waiting is the right decision for their pain-free or minimally symptomatic inguinal hernia How to choose between open or laparoscopic surgery if the option is available What to expect from open or laparoscopic repair as far as outcomes and adverse effects, including the risk of long-term chronic pain What to do if the hernia recurs Shared Decisionmaking: What To Discuss With Your Patients To facilitate shared decisionmaking, consider discussing these topics with your patients: If repair or watchful waiting is the right decision for their pain-free or minimally symptomatic inguinal hernia How to choose between open or laparoscopic surgery if the option is available What to expect from open or laparoscopic repair as far as outcomes and adverse effects, including the risk of long-term chronic pain What to do if the hernia recurs Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at

42 Resource for Patients Surgery for an Inguinal Hernia, A Review of the Research for Adults is a free companion to this continuing medical education activity. It can help patients talk with their health care professionals about the decisions involved with the care and maintenance of an inguinal hernia. It provides information about: Types of operative treatments Current evidence of effectiveness and harms Questions for patients to ask their doctor Resource for Patients Surgery for an Inguinal Hernia, A Review of the Research for Adults is a free companion to this continuing medical education activity. It can help patients talk with their health care professionals about the decisions involved with the care and maintenance of an inguinal hernia. It provides information about types of operative treatments, current evidence of effectiveness and harms, and questions for patients to ask their doctor. Reference Treadwell J, Tipton K, Oyesanmi O, et al. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review. Comparative Effectiveness Review No. 70 (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No ). AHRQ Publication No. 12-EHC091-EF. Rockville, MD: Agency for Healthcare Research and Quality; August Available at


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