Nir Hus MD., PhD. Ryder Trauma Center Journal Club. 3/21/2011

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Laparoscopic Vs Open repair in patients with 1O ventral or incisional hernia Nir Hus MD., PhD. Ryder Trauma Center Journal Club. 3/21/2011 Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

10 Randomized Clinical Trials: Carbajo 1999-- Carbajo MA, Martín del Olmo JC, Blanco JI, de la Cuesta C, Toledano M, Martín F, Vaquero C, Inglada L. “Laparoscopic treatment vs open surgery in the solution of major incisional and abdominal wall hernias with mesh.” Surgical Endoscopy 1999;13(3): 250–2 Moreno-Egea 2002-- Moreno-Egea A, Carrasco L, Girela E, Martín JG, Aguayo JL, Canteras M. “Open vs laparoscopic repair of spigelian hernia: a prospective randomized trial.” Archives of Surgery 2002;137(11): 1266–8. Barbaros 2006--Barbaros U, Asogulu O, Seven R, Erbil Y, Dinccag A, Deveci U, Ozarmagan S, Mercan S. “The comparison of laparoscopic and open ventral hernia repairs : a prospective randomized study.” Hernia 2006;11(1):51–56. Misra 2006-- Misra MC, Bansal VK, Kulkarni MP, Pawar DK. “Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study.” Surgical Endoscopy 2006;20(12):1839–45. Navarra 2007-- Navarra G, Musolino C, De Marco ML, Bartolotta M, Barbera A, Centorrino T. „Retromuscular sutured incisional hernia repair: a randomized controlled trial to compare open and laparoscopic approach.“ Surgical Laparoscopy and Endoscopy 2007;17(2):86–90. Olmi 2007-- Olmi S, Scaini A, Cesana GC, Erba L, Croce E. “Laparoscopic versus open incisional hernia repair: an open randomized controlled study.“ Surgical Endoscopy 2007;21(4):555–9. Pring 2008-- Pring CM, Tran V, O’Rourke N, Martin IJ. “Laparoscopic versus open ventral hernia repair: a randomized controlled trial.“ Australian and New Zealand Journal of Surgery 2008;78(10):903–6. Asencio 2009 --Asencio F, Aguiló J, Peiró S, Carbó J, Ferri R, Caro F, Ahmad M. “Open randomized clinical trial of laparoscopic versus open incisional hernia repair.” Surgical Endoscopy 2009;23(7):1441–1448. Buunen 2010-- Buunen M, Hansson BME, Nieuwenhuizen J, Jeekel J. “Laparoscopic versus open hernia repair: a multi-center clinical trial” Surgical Endoscopy 2009;23 Itani 2010-- Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L, for the Veternas Affairs Ventral Incisional Hernia Investigators. “Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial.” Archives of Surgery 2010;145(4):322–8. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital About 300,000 incisional hernias are being repaired in Europe. About 400,000 hernia procedures are preformed in the U.S.A. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Wound matrix deposition over time. Fibronectin and type III collagen constitute the early matrix. Type I collagen accumulates later and corresponds to the increase in wound tensile strength. Collagen is the principal structural protein of most tissues of the body. Normal tissue repair depends on collagen synthesis, deposition, and cross-linking. Fibroblasts synthesize and deposit collagen compounds as early as 48 hours after injury. Immature collagen is highly disorganized because it exists in a gel-like consistency. After a series of enzymatic processes, characteristic fibrils are produced. Subsequent intermolecular cross-links are responsible for a major portion of the strength of the collagen fibril. The entire process depends on tissue lactate and ascorbic acid and is directly related to tissue arterial carbon dioxide partial pressure (PaO2 ). In the absence of vitamin C, prolyl and lysyl hydroxylase will not activate, and oxygen will not be transferred to proline or lysine. Underhydroxylated collagen is produced, and characteristic collagen fibers are unable to form. Wound healing is poor and capillaries fragile. Without oxygen to hydroxylate proline and lysine, a local condition resembling scurvy tends to occur. Under normal conditions, collagen synthesis peaks by day 7, coincident with rapid increases in a tensile strength. The healing wound has the greatest mass at 3 weeks but will remodel itself over the next 6 to 12 months. Despite these impressive figures, the wound will achieve less than 15% to 20% of its ultimate strength by 3 weeks and only 60% by 4 months Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Collagen Type I Vs Type III Friedman et al. Ann Surg 1993; 218:754-760 Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Risk Factors Wound Infection Abdominal Compartment Syndrome Trauma Infected Mesh Incisional Hernia Multiple Re-operations through same wound Tumor resection Obesity, Malnutrition, Sepsis, DM Smoking Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Treatment Options Open Vs Laparoscopy Primary Repair Vs MESH Rives-Stoppa Components Separation Local flaps Vs Free tissue transfer Biologic Vs Synthetic Vs combination Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open 10 Randomized Control Studies with a total number of 880 patients with 1O ventral or incisional hernia. Not including umbilical or parastomal hernia. The recurrence rate was not different between laparoscopic and open surgery (RR 1.22; 95% CI 0.62 to 2.38, but patients were followed up for less than two years in half of the trials. Results on operative time were too heterogeneous. The risk of intraoperative enterotomy was slightly higher in laparoscopic hernia repair (OR2.33; 95% CI 0.53 to 10.35), but this result stems from only 7 cases with bowel lesions (5 vs. 2). The most clear and consistent result was that laparoscopic surgery reduced the risk of wound infection (RR = 0.26; 95% CI 0.15 to 0.46). Laparoscopic surgery shortened hospital stay significantly in 6 out of 9 trials. Laparoscopic repair apparently led to much higher in-hospital costs. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Studies were included irrespective of type of mesh Positioning of mesh, i.e., onlay, sublay, etc. The method of mesh fixation (suture, tacks, both, etc.) Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Hernia recurrence was selected as the primary outcome measure Longest f/u was 3 years. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Included only hernias with a diameter of >3 cm, Some trials did not include large hernias >15 cm diameter. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

10 Randomized Clinical Trials: Carbajo 1999-- Carbajo MA, Martín del Olmo JC, Blanco JI, de la Cuesta C, Toledano M, Martín F, Vaquero C, Inglada L. “Laparoscopic treatment vs open surgery in the solution of major incisional and abdominal wall hernias with mesh.” Surgical Endoscopy 1999;13(3): 250–2 Moreno-Egea 2002-- Moreno-Egea A, Carrasco L, Girela E, Martín JG, Aguayo JL, Canteras M. “Open vs laparoscopic repair of spigelian hernia: a prospective randomized trial.” Archives of Surgery 2002;137(11): 1266–8. Barbaros 2006--Barbaros U, Asogulu O, Seven R, Erbil Y, Dinccag A, Deveci U, Ozarmagan S, Mercan S. “The comparison of laparoscopic and open ventral hernia repairs : a prospective randomized study.” Hernia 2006;11(1):51–56. Misra 2006-- Misra MC, Bansal VK, Kulkarni MP, Pawar DK. “Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study.” Surgical Endoscopy 2006;20(12):1839–45. Navarra 2007-- Navarra G, Musolino C, De Marco ML, Bartolotta M, Barbera A, Centorrino T. „Retromuscular sutured incisional hernia repair: a randomized controlled trial to compare open and laparoscopic approach.“ Surgical Laparoscopy and Endoscopy 2007;17(2):86–90. Olmi 2007-- Olmi S, Scaini A, Cesana GC, Erba L, Croce E. “Laparoscopic versus open incisional hernia repair: an open randomized controlled study.“ Surgical Endoscopy 2007;21(4):555–9. Pring 2008-- Pring CM, Tran V, O’Rourke N, Martin IJ. “Laparoscopic versus open ventral hernia repair: a randomized controlled trial.“ Australian and New Zealand Journal of Surgery 2008;78(10):903–6. Asencio 2009 --Asencio F, Aguiló J, Peiró S, Carbó J, Ferri R, Caro F, Ahmad M. “Open randomized clinical trial of laparoscopic versus open incisional hernia repair.” Surgical Endoscopy 2009;23(7):1441–1448. Buunen 2010-- Buunen M, Hansson BME, Nieuwenhuizen J, Jeekel J. “Laparoscopic versus open hernia repair: a multi-center clinical trial” Surgical Endoscopy 2009;23 Itani 2010-- Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L, for the Veternas Affairs Ventral Incisional Hernia Investigators. “Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial.” Archives of Surgery 2010;145(4):322–8. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Laparoscopy The laparoscopic techniques were performed through 3 or 4 trocars. All studies implanted non-resorbable meshes. >3cm overlap Mesh fixation was done by suture fixation alone (Navarra 2007), Tacks alone (Misra 2006; Olmi 2007), Or a combination of sutures and tacks (Barbaros 2006; Itani 2010; Moreno-Egea 2002; Pring 2008). Some trials used more than one mesh fixation technique (Asencio 2009; Carbajo 1999). Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Open Open surgery included sublay (i.e. retromuscular) mesh implantation in most trials (Carbajo 1999; Misra 2006; Moreno- Egea 2002;Navarra 2007;Olmi 2007). Olmi 2007, onlay mesh repair had to be performed in a few cases because of difficult dissection of the abdominal planes. Asencio 2009, allowed the operating team to select between sublay and onlay technique. ~2/3 of patients received onlay repair. Only in two trials onlay mesh repair was the method of choice (Barbaros 2006; Itani 2010). Pring 2008, used the intraperitoneal onlay mesh (IPOM) technique . Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Open Conversions from laparoscopic to open surgery were not described in most of the trials (Barbaros 2006; Carbajo 1999; Misra 2006; Moreno-Egea 2002; Navarra 2007; Olmi 2007; Pring 2008). In 3 trials, some patients from the laparoscopic group had to be converted (Asencio 2009; Buunen 2010; Itani 2010), but the converted cases were analyzed according to intention-to- treat (ITT) in all 3 trials. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Duration of follow-up was 2 years or longer in 5 trials (Carbajo 1999; Itani 2010; Olmi 2007; Moreno-Egea 2002; Pring 2008). In 4 trials, follow-up lasted between 1 and 2 years (Asencio 2009; Barbaros 2006; Misra 2006). In the 2 remaining trials, length of follow-up was less than 1 year (Navarra 2007) F/U not reported (Buunen 2010). Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Costs were reported in two studies ( Misra 2006;Olmi 2007). Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Not a single trial applied any form of blinding. In two trials the analyses were clearly not according to the intention-to-treat principle. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Lap Vs Open Barbaros 2006, excluded cases with major complications from the analysis of hospital stay. Can lead to overoptimistic results! Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Comparison Laparoscopic Vs open repair, Outcome: Hernia recurrence. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic Vs Open repair Duration of surgery Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic Vs Open repair, Enterotomy Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic Vs Open repair, Local seroma Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic Vs Open repair, Local infection Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic Vs Open repair, Local infection requiring mesh removal Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic versus open repair, Length of hospital stay. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic Vs Open repair, Hernia recurrence Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Laparoscopic versus open repair, Costs of therapy. Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Rives-Stoppa procedure for repair of large incisional hernias: experience with 57 patients. Bauer JJ, Harris MT, Gorfine SR, Kreel I. Hernia. 2002 Sep;6(3):120-3. Epub 2002 Jul 13. “Retro-rectus” mesh repair – the prosthesis is placed between the rectus abdominis muscle and the posterior sheath or pre-peritoneal space 57pts – 6 years 26.4% (15 pt.) prev incisional hernia repair ePTFE: 8x8 to 20x28cm Mean f/u 35 months 12.3% Seromas Two (3.5%) infected mesh – removed One hernia recurrence(removed prosthesis) polypropylene, expanded polytetrafluoroethylene (ePTFE), Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Mesh closure Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Rives-Stoppa Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Three Staged Closure Mostly in pt’s w/ abdominal compartment syndrome Stages: Absorable mesh / VAC STSG Ventral hernia repair Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Components separation Oscar Ramirez (1990) describes technique Cadaveric dissection Incision 1cm lateral to linea semilunaris Ext oblique (EO) easily separated from internal oblique (IO) in AVASCULAR plane EO has limited advancement Rectus w/ IO flap can be advanced Unilateral - 5cm epigastrum/10cm middle/3cm suprapubic Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital Component separation Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital

Nir Hus MD., PhD. Ryder Trauma Center Jackson Memorial Hospital