1. Sunday June 3, 2007 Istanbul Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired? Management of the Asymptomatic Inguinal Hernia Robert J. Fitzgibbons MD, FACS Harry E. Stuckenhoff Professor of Surgery Creighton University School of Medicine Omaha, Nebraska USA Turkish Chapter of the American College of Surgeons

2. Sunday June 3, 2007 Istanbul In 2007 Inguinal Hernia Repair:  Has a Low Recurrence Rate  Is an Outpatient Procedure  Can be Performed Under Local Anesthesia  Is Associated with an Uneventful Recovery in Most

3. Sunday June 3, 2007 Istanbul Most North American Surgeons Have been Taught That The Indication for Elective Inguinal Herniorrhaphy = The Presence of a Hernia! Regardless of Symptoms

4. Sunday June 3, 2007 Istanbul Annual Inguinal Herniorrhaphy Rate  US 2800 Per Million  UK 1000 Per Million

5. Sunday June 3, 2007 Istanbul So the Arguments Go Like This :  Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High  The Mortality Rate Associated with a Hernia Accident is Unacceptable  Progression is Inevitable,  Incarceration and or Strangulation is Likely  Operation Becomes More Difficult the Longer it is Delayed

6. Sunday June 3, 2007 Istanbul Patient Scenario  65 Year Old Healthy Male With a Unilateral, Easily Reducible Inguinal Hernia  He has No Symptoms and Has Not Had to Alter His Lifestyle in Any Way But His Wife is Worried About His Visible Bulge  He is Retired but Physically Active

7. Sunday June 3, 2007 Istanbul Surgical Counseling The Dreaded Complication  A Hernia Accident  Strangulation  Bowel Obstruction

8. Sunday June 3, 2007 Istanbul Surgical Counseling  The Hernia will Inevitably Progress  There Will be a Penalty to Pay in Terms of Recurrence and Complications Because Hernias Become More Difficult to Repair the Longer They Remain Unrepaired  Don’t Wait Until Your Health Declines!

9. Sunday June 3, 2007 Istanbul Chronic Groin Pain

10. Sunday June 3, 2007 Istanbul Annals of Surgery 244(2), August 2006 Sweden

11. Sunday June 3, 2007 Istanbul Fränneby and Others. Annals of Surgery 244(2), August 2006 Sweden  Swedish Hernia Register  3000 Patients with Primary Hernia Repair in 2000  2456 Patients (86%) Returned a postal questionnaire  758 Patients (31%), Some Pain  144 cases (6%), Interfered with Work or Leisure Activities

12. Sunday June 3, 2007 Istanbul So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy?  Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High  The Mortality Rate Associated with a Hernia Accident is Unacceptable  Progression is Inevitable,  Incarceration and or Strangulation is Likely  Operation Becomes More Difficult the Longer it is Delayed

13. Sunday June 3, 2007 Istanbul So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy?

14. Sunday June 3, 2007 Istanbul Risk of a Hernia Accident What is Known Adults  Short Duration  Old Age  Femoral Hernia  Coexisting Medical Disease Children  Young Age  Male  Right Sided Hernia Rai S, Chandra SS, Smile SR.. A study of the risk of strangulation and obstruction in groin hernias. Aust N Z J Surg 1998 Sep;68(9):650-4. India, 1985-1995 Who is at Risk?

15. Sunday June 3, 2007 Istanbul Risk of a Hernia Accident What is Not Known The INCIDENCE

16. Sunday June 3, 2007 Istanbul Risk of a Hernia Accident What is Not Known What is the Problem? n Surgeons are Taught That All Inguinal Hernias Should be Repaired to Prevent Complications. Therefore No Whole Groups of Patients With Hernias Untreated Exist n Variability of Surgeon Practice Patterns u Surgeon A vs. Surgeon B

17. Sunday June 3, 2007 Istanbul Therefore Only Historical Data Available

18. Sunday June 3, 2007 Istanbul 2 Unique Data Bases  Paul Berger’s Truss Clinic  Berger P: Résultats de ľExamen de Dix Mille Observations de Hernies. Paris, Extrait du neuvième congres francais de chirurgie 1895,1896  Cali Colombia  Neutra R, Velez A, Ferreda R, Galan R. Risk of incarceration of inguinal hernia in Cali, Columbia. Chron Dis 1981;34:561-564.

19. Sunday June 3, 2007 Istanbul Berger’s Truss Clinic n 1880 - 1884 n Elective Herniorrhaphy Shunned n 8633 Patients n 242 Hernia Accidents = Probability of Hernia Accident Per Year Is 0.0037

20. Sunday June 3, 2007 Istanbul Cali Colombia n One Year (1965 – 1966) Government Initiative To Aggressively Examine A Stratified Random Sample Of Its Civilian Population To Determine The Frequency Of Common Conditions Such As Inguinal Hernia n Hospital Records = Probability Of Hernia Accident Per Year Is 0.0038

21. Sunday June 3, 2007 Istanbul Cumulative Probability of an Accident =1 – (1 – p) e p = probability of an accident per hernia patient per year (0.00375) e = life expectancy* *National Center for Health Statistics: Vital statistics of the United States, 1980. Life tables, 2(6). DHHS Publ. No. (PHS) 84-1104, 1984. National Center for Health Statistics: Vital statistics of the United States, 2001. Life tables, 52(14), 2004.

22. Sunday June 3, 2007 Istanbul The Lifetime Risk of a Hernia Accident Males 1980 18 yr1/5.49 72 yr1/27.03

23. Sunday June 3, 2007 Istanbul  One Hernia Accident Within Two Year Follow-up 4 Months After Randomization (0.3%)  One Additional Hernia Accident at 4 Years  Overall Accident Rate 0.0018 Events/ Patient Year Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292

24. Sunday June 3, 2007 Istanbul So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy?

25. Sunday June 3, 2007 Istanbul

26. Operative Mortality for Patients with Obstructed Inguinal Hernias Authors Beller & Colp(1926) Frankau(1931) Guillen & Aldrete(1970) Anderson & Ostberg(1972) Mortality Rate 10.9% 19.7% 13.2% 13.8%

27. Sunday June 3, 2007 Istanbul

28. Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 No Herniorrhaphy Related Mortality

29. Sunday June 3, 2007 Istanbul So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy?

30. Sunday June 3, 2007 Istanbul

31. Cumulative Probability of an Inguinal Hernia Becoming Irreducible Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9. 30% by 10 Years N= 699

32. Sunday June 3, 2007 Istanbul But Incarceration ≠ Strangulation Many Men with Chronically Incarcerated Inguinal Hernias are Minimally Symptomatic

33. Sunday June 3, 2007 Istanbul Cumulative Probability of an Inguinal Hernia Becoming Irreducible Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.  Vs. Emergency Surgery  10 patients  1 with infarcted small bowel  1 with infarcted omentum  No Deaths or Serious Complication

34. Sunday June 3, 2007 Istanbul Cumulative Probability of Pain Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9. 90% with Pain by 10 Years

35. Sunday June 3, 2007 Istanbul Cumulative Probability of Pain Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.  Leisure Activities Affected in Only 29%  Only 13% of Employed Patients had to Take Time Off Work Because of Hernia-related Symptoms.

36. Sunday June 3, 2007 Istanbul Two Year Primary Outcomes: No differences in Pain or Physical function WW 5.1% TFR3.2%, Difference 2.86%;95% Confidence Interval, -0.04% -5.72%, P=.52 WW ↑.29 Points TFR ↑.13%, Difference.16;95% Confidence Interval, -1.2 – 1.5 Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292

37. Sunday June 3, 2007 Istanbul Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 Likelihood of a Hernia Repair in WW

38. Sunday June 3, 2007 Istanbul So Just How Valid are These Arguments For Routine Inguinal Herniorrhaphy?

39. Sunday June 3, 2007 Istanbul MONTHS BETWEEN RANDOMIZATION AND SURGERY P TOTAL N=353  6 N=288 >6 N=65 Intraoperative (%) 3(1.04)0.001.003(.85) Postoperative Hernia site infection Wound hematoma Scrotum hematoma Orchitis Seroma Groin neuralgia Leg neuralgia Urinary retention Urinary infection Other 5(1.74) 15(5.21) 11(3.82) 5(1.74) 2(0.69) 1(0.35) 7(2.43) 0(0.00) 12(4.17) 1(1.54) 6(9.23) 3(4.62) 0(0.00) 1(1.54) 0(0.00) 1(1.54) 2(3.08) 1.00 0.2431 0.7280 0.5890 0.4580 1.00 0.1841 0.3572 0.1841 1.00 6(1.70) 21(5.95) 14(3.97) 5(1.42) 3(0.85) 2(0.57) 1(0.28) 7(1.98) 1(0.28) 14(3.97) Total49(17.01)14(21.54)0.375463(17.85) Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292 PERIOPERATIVE COMPLICATIONS

40. Sunday June 3, 2007 Istanbul  No Difference In Recurrence Rate  No Difference in Satisfaction with Care (97%) Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA 2006;295:285-292

41. Sunday June 3, 2007 Istanbul No Longer a Valid Argument!  Conventional Anterior, Non-prosthetic  Marcy  Bassini  Moloney Darn  Shouldice  McVay Cooper’s Ligament Repair  Miscellaneous Repairs  Conventional Preperitoneal, Non Prosthetic  Historical Interest  Bassini  Conventional Anterior, Prosthetic  Lichtenstein Tension Free Hernioplasty  Mesh Plug And Patch  Conventional Preperitoneal, Prosthetic  The Anterior Approach  Read-rives  The Posterior Approach  Wantz /Stoppa/Rives (Giant Prosthetic Reinforcement Of The Visceral Sac)  Nyhus /Condon (iliopubic Tract Repair)  Kugel/Ugahary  Combination Anterior and Preperitoneal, Prosthetic  The Bilayer Prosthetic Repair  Laparoscopic Inguinal Herniorrhaphy  Transabdominal Preperitoneal (TAPP)  Totally Extraperitoneal (TEP)  Intraperitoneal Onlay Mesh Procedure (IPOM)

42. Sunday June 3, 2007 Istanbul In Summary  Mortality For Strangulation is Not as Great as Once Thought  Increasing Morbidity Under Observation is Not Inevitable  There Isn't a Significant Penalty for Waiting  Watchful Waiting is an Acceptable Alternative to Routine Operation for a Minimally Symptomatic Inguinal Hernia

43. Sunday June 3, 2007 Istanbul Ann Surg 2006;244: 167–173

44. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia:  Does Not Affect the Rate of Long-term Chronic Pain  May Be Beneficial to Patients in Improving Overall Health  May Reduce Potentially Serious Morbidity

45. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study  Recruitment Problems  160 Patients (Original Design = 250)  Older Age Group  55 Years or Older  More Advanced Hernia  Visable bulge Required  Short Follow/up  1 Year

46. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: n Does Not Affect the Rate of Long-term Chronic Pain

47. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study Conclusions Repair of an Asymptomatic Inguinal Hernia: n Does Not Affect the Rate of Long-term Chronic Pain (But the WW Group Did Not Have to Endure an Operation!!!)

48. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study

49. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study On An Intention-to-treat Analysis, There Was a Consistent Trend to Improvement of About 5 Points in All of the SF-36 Dimensions (Except Emotional Role) in the Operation Group Compared With the Observation Group

50. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study

51. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study “There Were 3 Serious Adverse Events in the Observation Group : 1 Patient Had an Acute Hernia, 1 Had a Postoperative Stroke, and 1 Had a Myocardial Infarction and Died Postoperatively. The Patient With the Acute Hernia had It Reduced at Another Hospital.”

52. Sunday June 3, 2007 Istanbul Problems with the O’Dwyer Study n This is a SICK Group of Patients u 2 Of the Operation Patients Died Before they could be Operated (1 of Cancer,1 Cardiac) u 9 More have Already Died n The Mean Time for Operation in the “Immediate Operation Group” was 103 Days

53. Sunday June 3, 2007 Istanbul Caveats  Be Careful With Extrapolation  Moderately Symptomatic Male??  Do Not Extrapolate to Woman!!

54. Sunday June 3, 2007 Istanbul

56. Women Men

57. Sunday June 3, 2007 Istanbul Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired? Management of the Asymptomatic Inguinal Hernia Robert J. Fitzgibbons MD, FACS Harry E. Stuckenhoff Professor of Surgery Creighton University School of Medicine Omaha, Nebraska USA Turkish Chapter of the American College of Surgeons