Does prophylactic biological mesh placement protect against the development of
incisional hernia i...
ABSTRACT
PURPOSE: The purpose of this study is to determine whether or not the prophylactic use
of a biological prosth...
for age, sex, body mass index, albumin, smoking, diabetes, prior surgery, seroma
formation, weight loss, and mesh placeme...
INTRODUCTION
The traditionally recommended method of abdominal wall closure following laparotomy
includes the use of a n...
infectious complications. The purpose of this study is to determine whether or not the
prophylactic use of a biologic mes...
RESULTS
During the study period 134 patients (mean age 40.4 years, 80.7% female) underwent
open roux-en-y gastric bypass...
protective against incisional hernia development (adjusted odds ratio: 0.06, 95% CI:
0.006, 0.69, p = 0.02). (Table 2)
...
At three year follow-up, five patients in the non-mesh group had developed incisional
hernias while all in the mesh group...
REFERENCES
1. Mudge M, Hughes LE. Incisional hernia: a ten year prospective study of
incidencece and attitudes. B...
Bruijninckx CM, Jeekel JJ. A comparison of suture repair with mesh repair for
incisional hernia. N Engl J Med 2000;343...
17. Kim H, Bruen K, Vargo D. Acellular dermal matrix in the management of high-
risk abdominal wall defects. Am ...
Diabetes 21 (33.87%) 14 (32.56%) 0.89
Sleep apnea ...
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Prevention of hernia in open RNY

Using alloderm to prevent incisional hernia after open gastric bypass surgery
Published on: Mar 4, 2016
Published in: Health & Medicine      
Source: www.slideshare.net


Transcripts - Prevention of hernia in open RNY

  • 1. Does prophylactic biological mesh placement protect against the development of incisional hernia in high-risk patients? Llaguna OH, Avgerinos DV, Nagda P, Elfant D, Leitman IM, Goodman E Department of Surgery, Beth Israel Medical Center, Albert Einstein College of Medicine, New York, NY Correspondence to: Omar H. Llaguna, Beth Israel Medical Center, 16 Street at First Avenue, Suite BH 15-20, New York, NY 10003, Tel: 1-917-577-9888, e-mail: ollaguna@chpnet.org Presented at the 4th Annual Academic Surgical Congress, February 3-6, Fort Myers, Florida.
  • 2. ABSTRACT PURPOSE: The purpose of this study is to determine whether or not the prophylactic use of a biological prosthesis protects against the development of incisional hernia in a high- risk patient population. METHODS: A prospective, non-randomized trial was conducted on 134 patients undergoing open roux-en-y gastric bypass by a single surgeon, at two institutions, from January 2005 to November 2007. At Hospital A, all patients (n = 59) underwent fascial closure of the abdominal midline wound with the prophylactic placement of a biologic mesh (Alloderm™) in an in-lay fashion. Patients at Hospital B (n = 75) underwent primary abdominal wall closure using 0 PDS in a running fashion. Data collected included patient demographics, abdominal wall closure technique, post-operative wound complications, follow-up period and incidence of incisional hernia. RESULTS: During the study period 134 patients (mean age 40.4 years, 80.7% female) underwent open roux-en-y gastric bypass (59.7% mesh, 41.5% non-mesh). Twenty-eight patients were excluded from the analysis secondary to short follow-up period (mesh = 13, non-mesh = 11) and/or re-operative surgery unrelated to the development of an incisional hernia (mesh = 2, non-mesh = 2). The mean follow-up period was 17.3 ± 8.5 months. The overall incidence of incisional hernia was 11.3% (95% CI: 5.2, 17.45). The incidence of incisional hernia was significantly lower in the mesh group versus the non-mesh group (2.3% versus 17.7%, p = 0.014). In a multivariate logistic regression model that adjusted
  • 3. for age, sex, body mass index, albumin, smoking, diabetes, prior surgery, seroma formation, weight loss, and mesh placement, the development of incisional hernia was found to be associated with smoking (adjusted odds ratio 8.46, 95% CI: 1.79, 40.00, p = 0.007) while prophylactic mesh was noted to be protective against hernia development (adjusted odds ratio: 0.06, 95% CI: 0.006, 0.69, p = 0.02). CONCLUSION: The prophylactic use of biologic mesh for abdominal wall closure appears to reduce the incidence of incisional hernia in patients with multiple risk factors for incisional hernia development.
  • 4. INTRODUCTION The traditionally recommended method of abdominal wall closure following laparotomy includes the use of a non-absorbable or slowly absorbing running suture with a one cm distance between stitches and the fascial margin. Despite technical improvement and adherence to principles, the overall incidence of incisional hernia following laparotomy 1-3 remains reported to be between 11% and 23%. Although patient related risk factors such as a history of smoking, morbid obesity, pulmonary disease, abdominal aortic aneurismal disease, prior abdominal surgery, or surgical site infections 4, cannot be controlled modifications in the standard abdominal wall closure in pre-identified high- risk patient populations may reduce the incidence of post-operative incisional hernias. One simple and feasible modification may be the prophylactic placement of subfascial prosthetic materials at the time of initial laparotomy. 5 - 11 While many studies validate the use of mesh for incisional hernia repair , few attempt to prove its usefulness in the prophylaxis of incisional hernia development. Although limited, the available data suggest that the prophylactic use of a non-absorbable mesh at the time of initial laparotomy confers protection against hernia development.12 - 16 Surgeons, however, are appropriately hesitant to adopt this practice citing the paucity of data demonstrating the proposed technique’s effectiveness, as well as concerns with regards to the placement of permanent mesh at the time of a potentially contaminated case. To help nullify these concerns we suggest that Alloderm™, a biologic acellular matrix prosthetic marterial, which has been found to be safe to use in contaminated cases, 17 – 18 may be an ideal for prophylactic mesh placement obviating the concern for
  • 5. infectious complications. The purpose of this study is to determine whether or not the prophylactic use of a biologic mesh is protective against the development of incisional hernia in a high-risk patient population, and if so is it at the cost of added morbidity. METHODS A prospective, non-randomized trial was conducted on 134 patients undergoing open roux-en-y gastric bypass by a single surgeon, at two institutions, from January 2005 to November 2007. At Hospital A, all patients (n = 59, 44.0%) received prophylactic placement of a biologic mesh (Alloderm™ - Life Cell Corporation) in an in-lay fashion during abdominal wall closure as an institutionally approved internal review board protocol. The mesh was placed below the fascia with several interrupted #1 polydioxanone sulfate (PDS ® – Ethicon Corporation) monofilament sutures and the fascia was closed in a primary running fascia also with #1 polydiaxone sulfate suture with a one cm distance between stitches and the fascial margin. Patients at Hospital B (n=75, 56%) underwent primary abdominal wall closure using # 0 polydioxanone monofilament suture in a similar running fashion. At both institutions the primary surgeon performed the entire abdominal wall closure to minimize variability in technique. Data collected included patient demographics, abdominal wall closure technique (mesh versus non- mesh), post-operative wound complications, follow-up period and incidence of incisional hernia. Data was analyzed using Statistical Package for the Social Sciences for Windows 16 (SPSS Inc. Chicago, IL). A p-value less than 0.05 was considered statistically significant.
  • 6. RESULTS During the study period 134 patients (mean age 40.4 years, 80.7% female) underwent open roux-en-y gastric bypass (44% mesh, 56% non-mesh). Twenty-eight patients were excluded from the analysis secondary to short follow-up period (mesh = 13, non-mesh = 11) and/or re-operative surgery unrelated to the development of an incisional hernia (mesh = 2, non-mesh = 2). The mean follow-up period was 17.25 ± 8.48 months (mesh 16.59 ± 7.05, non-mesh 17.72 ± 9.39, p = 0.50). No significant difference was noted between the mesh and non-mesh group with regards to age (p = 0.06), gender (p = 0.10), pre-operative body mass index (BMI) (p = 0.26), total weight loss (p = 0.53), diabetes (p = 0.89), sleep apnea (p = 0.22), asthma (p = 0.06), exertional dyspnea (p = 0.12), depression (p = 0.65), hypertension (p = 0.36), degenerative joint disease (p = 0.94), smoking (p = 0.31), and wound infection (p = 0.07). (Table 1) Patients in the non-mesh group were more likely to have undergone prior abdominal surgery (p = 0.001), while those in the mesh group had an overall lower post-operative BMI (p = 0.05) at the time of last follow-up. The overall incidence of incisional hernia was 11.32% (95% CI: 5.19, 17.45). The incidence of incisional hernia was significantly lower in the mesh group (mesh 2.27%, 95% CI: -2.31, 6.86, non-mesh 7.74%, 95% CI: 7.96, 27.52, p = 0.01), while the incidence of seroma was lower in the non-mesh group (mesh 13.64%, non- mesh 1.64%, p = 0.01). (Table 1) In a multivariate logistic regression model that adjusted for age, sex, BMI, albumin, smoking, diabetes, prior surgery, seroma formation, weight loss, and mesh placement, hernia was found to be associated with smoking (adjusted odds ratio 8.46, 95% CI: 1.79, 40.00, p = 0.008) while prophylactic mesh was noted to be
  • 7. protective against incisional hernia development (adjusted odds ratio: 0.06, 95% CI: 0.006, 0.69, p = 0.02). (Table 2) CONCLUSION Since its first description in 1975 by Dr. Rene Stoppa an abundance of data has emerged supporting the superiority of tension free mesh repair over primary suture repair in the management of incisional hernias.5 – 11 At present, tension free mesh repair is standard in the operative management of incisional hernias, having proven to be efficacious even in the face of multiple non-modifiable patient related risk factors, decreasing the incidence of recurrence by as much as 50% in some series.10 Built on this success and fostered by an era of newer biologic mesh which can safely be used in spite of intra-abdominal contamination, the question arises: can abdominal wall closure with permanent mesh be similarly used to prevent, rather than repair, incisional hernias? Some of this data is promising. Strzelczyk and coworkers, in a non-randomized prospective study of patients undergoing open roux-en-y gastric bypass, found no hernias in the prophylactic mesh group (n = 12) and nine in the standard closure group (n = 48).13 A follow-up randomized controlled study by Strzelczyk again found that none of the patients assigned to the prophylactic polyproplene mesh group (n = 36) developed incisional hernias while one- fifth of those in the primary closure group (n = 38) did.14 Similarly, Gutiérrez de la Peña and coworkers, found prophylactic polypropylene mesh placement to be protective against incisional hernia development when they randomized a 100 patients to either primary abdominal wall closure or supra-aponeurotic polypropylene mesh placement.15
  • 8. At three year follow-up, five patients in the non-mesh group had developed incisional hernias while all in the mesh group were without hernia (P=0.02).15 In contrast to these positive findings, Pan and coworkers were unable to show any reduction in incisional hernia development with the prophylactic use of a polyglactin mesh.19 This study however differs dramatically from the prior in that an absorbable mesh was used, placed intraperitoneally without fixation, and the overlaying fascia approximated with interrupted absorbable suture.19 The incisional hernia rate following non-mesh closure in our series was 17.7%, a number similar to that reported in the literature.1 – 3, 20 Patients who received prophylactic mesh placement however, experienced a significantly lower incisional hernia rate (2.4%) with the only added morbidity being increased seroma formation (mesh 13.6%, non-mesh 1.6%, p = 0.01). However, seroma formation following hernia repair with mesh is a common occurrence, with some laparoscopic series reporting a 35% incidence discovered clinically, and a 100% found on subsequent ultrasonic evaluation.21 These finding have lead many to consider it an expected mesh related reaction rather than a complication, a small price to pay for a sturdier repair, or in our case a diminutive incisional hernia rate. This is the first study to demonstrate the benefit from the prophylactic placement of a biological prosthetic material at the time of midline laparotomy in patients at high risk for the development of incisional hernia. Although the study was limited to patients undergoing open roux-en-y gastric bypass, we believe these results apply to patients with recognized risk factors for incisional hernia development such as diabetes, morbid obesity, and history of smoking. The conclusions from this study will be more compelling in the future with a larger sample size and prospective randomization.
  • 9. REFERENCES 1. Mudge M, Hughes LE. Incisional hernia: a ten year prospective study of incidencece and attitudes. Br J Surg 1985;72:70–1 2. Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major laparotomies. Br Med J (Clin Res Ed) 1982;284(6364):519- 20 3. Livingston EH. Complications of bariatric surgery. Surg Clin N Am 85 (2005): 853–868 4. Shell DH 4th, de la Torre J, Andrades P, Vasconez LO. Open repair of ventral incisional hernias. Surg Clin North Am. 2008 Feb;88(1):61-83, viii 5. George CD, Ellis H. The results of incisional hernia repair: a twelve year review. Ann R Coll Surg Engl 1986;68:185-187 6. Stoppa RE. The treatment of complicated groin and incisional hernias. World J Surg 1989;13:545-554 7. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 1998;133:378-382. 8. Morris-Stiff GJ, Hughes LE. The outcomes of nonabsorbable mesh placed within the abdominal cavity: literature review and clinical experience. J Am Coll Surg 1998;186:352-367 9. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN, Boelhouwer RU, de Vries BC, Salu MK, Wereldsma JC,
  • 10. Bruijninckx CM, Jeekel JJ. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000;343(6):392-8 10. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EAM, Troidl H. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. British Journal of Surgery 2002;89:50-6 11. Burger JWA, Luijendijk RW, Hop WCJ, Halm JA, Verdaasdonk EGG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Annals of Surgery 2004;240:578-85 12. Bellón JM, López-Hervás P, Rodríguez M, García-Honduvilla N, Pascual G, Buján J.Midline Abdominal Wall Closure: A New Prophylactic Mesh Concept . J Am Coll Surg. 2006 Oct;203(4):490-7 13. Strzelczyk J, Czupryniak L, Loba J, Wasiak J. The use of polypropylene mesh in midline incision closure following gastric by-pass surgery reduces the risk of postoperative hernia. Langenbecks Arch Surg. 2002 Nov;387(7-8):294-7 14. Strzelczyk JM, Szymański D, Nowicki ME, Wilczyński W, Gaszynski T, Czupryniak L. Randomized clinical trial of postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006 Nov;93(11):1347-50 15. Gutiérrez de la Peña C, Medina C, Dominguez E, Medina J. Primary closure of laparotomies with high risk of incisional hernia using prosthetic material: analysis of usefulness. Hernia 2003;7:134–136 16. O'Hare JL, Ward J, Earnshaw JJ. Late results of mesh wound closure after elective open aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2007 Apr;33(4):412-3
  • 11. 17. Kim H, Bruen K, Vargo D. Acellular dermal matrix in the management of high- risk abdominal wall defects. Am J Surg. 2006 Dec;192(6):705-9 18. Patton JH Jr, Berry S, Kralovich KA. Use of human acellular dermal matrix in complex and contaminated abdominal wall reconstructions. Am J Surg. 2007 Mar;193(3):360-3 19. Pans A, Elen P, Dewé W, Desaive C. Long-term results of poly- glactin mesh for the prevention of incisional hernias in obese patients. World J Surg 1998;22:479– 483 20. Horowitz MI, Leitman IM, Risk Factors for the Development of Incisional Hernia Following Roux-en-Y Gastric Bypass Surgery, The Open Surgery Journal, 2008, 2, 15-17. 21. Susmallian S, Gewurtz G, Ezri T, Charuzi I. Seroma after laparoscopic repair of hernia with PTFE patch: is it really a complication? Hernia. 2001 Sep;5(3):139-41 Tables and figures Table 1 Patient demographics and characteristics Non-mesh Mesh Variable 62 (58.5%) 44 (41.5 %) P value‡ n (%) n (%) Age (mean ± SD) 39.39 ± 11.08 43.73± 11.81 0.06 Gender Male 10 (16.13%) 13 (29.55%) 0.10 Female 52 (83.87%) 31 (70.45%) Pre-operative BMI (mean ± SD) 50.38 ± 9.31 52.58 ± 10.59 0.26 Post-operative BMI (mean ± SD) 33.48 ± 8.56 36.75 ± 7.73 0.05 Weight loss (mean ± SD) 103.25 ± 63.74 96.18 ± 46.16 0.53 Pre-operative albumin (mean ± SD) 4.04 ± 0.32 3.92 ± 0.26 0.14
  • 12. Diabetes 21 (33.87%) 14 (32.56%) 0.89 Sleep apnea 12 (19.35%) 13 (29.55%) 0.22 Asthma 18 (29.03%) 6 (13.64%) 0.06 Hypothyroidism 4 (6.75%) 5 (11.36%) 0.37 Exertional dyspnea 23 (37.10%) 10 (22.73%) 0.12 Prior abdominal surgery 33 (54.10%) 10 (22.73%) 0.001 Depression 15 (24.19%) 9 (20.45%) 0.65 Hypertension 31 (50.00%) 18 (40.91%) 0.36 DJD 58 (93.55%) 41 (93.18%) 0.94 Smoking No 49 (79.03%) 31 (70.45%) 0.31 Yes 13 (20.97%) 13 (29.55%) Incisional hernia 11 (17.74%) 1 (2.27%) 0.01 Wound infection 1 (1.61%) 4 (9.09%) 0.07 Seroma 1 (1.61%) 6 (13.64%) 0.01 Follow-up period (mean ± SD) 17.72 ± 9.39 16.59 ± 7.05 0.50 ‡ Fisher’s exact test Table 2 Comparison of hernia and non-hernia group Hernia group Non-hernia group Variable 12 (11.3%) 94 (88.7%) P value‡ n (%) n (%) Biologic mesh use 1 (8.33%) 43 (45.74%) 0.01 Follow-up period (mean ± SD) 18.01 ± 9.51 17.16 ± 8.03 0.47 Age (mean ± SD) 39.75 ± 12.75 41.37 ± 11.47 0.64 Gender Male 1 (8.33%) 22 (23.40%) 0.46 Female 11 (91.67%) 72 (76.60%) Pre-operative BMI (mean ± SD) 53.36 ± 7.54 51.03 ± 10.13 0.44 Post-operative BMI (mean ± SD) 33.13 ± 7.29 35.06 ± 8.49 0.45 Weight loss (mean ± SD) 125.75 ± 38.73 97.07 ± 58.24 0.10 Pre-op albumin (mean ± SD) 3.87 ± 0.31 4.01 ± 0.30 0.13 Diabetes 6 (50.00%) 29 (31.18%) 0.21 Sleep apnea 1 (8.33%) 24 (25.53%) 0.29 Asthma 2 (16.67%) 22 (23.40%) 0.73 Prior abdominal surgery 6 (50.00%) 37 (39.78%) 0.54 Smoking No 5 (41.67%) 75 (79.79%) 0.008 Yes 7 (58.33%) 19 (20.21%) Wound infection 0 (0.00%) 5 (5.32%) 1.00 Seroma 1 (8.33%) 6 (6.38%) 0.58 ‡ Fisher’s exact test, BMI = body mass index

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