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Hernia

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A novel tool to evaluate bias in literature on use of biologic mesh in abdominal wall hernia repair

  • J. Con
  • L. Zarain
  • S. GognaEmail author
  • D. J. Samson
  • K. Prabhakaran
  • S. Gashi
  • E. Tilley
  • R. Latifi
Review
  • 33 Downloads

Abstract

Purpose

Biologic meshes are being increasingly used for abdominal hernia repair in high-risk patients or patients with a previous history of wound infection, due to their infection-resistant properties. Several studies have been carried out to assess whether biologic mesh is superior to synthetic mesh, as well as to establish guidelines for their use. Unfortunately, most of these studies were not rigorously designed and were vulnerable to different types of bias. The systematic reviews that have been published so far on this topic contain the same biases and limitations of the primary articles that are analyzed. The lack of a literature review on the bias on the use of biological mesh prompted us to conduct the literature search, assessment and plan this article.

Methods

We performed a literature search in PubMed, Embase and Cochrane databases of systematic reviews on biologic mesh for ventral hernia repair. The literature review was conducted using the Population, Intervention, Comparisons, Outcomes and Design approach. We identified 40 studies that matched the stringent criteria we had set. We then created a 13-point instrument to assess for bias and applied it on the primary studies that we intended to analyze.

Results

Most primary studies are case series or case reports of patients undergoing abdominal hernia repair with biologic mesh, without any comparison group, and the inclusion of cases was only specified to be consecutive in 6 out of 40 cases. In terms of assessing outcomes, in none of the 40 articles were the outcome assessors blinded to the intervention or exposure status of participants.

Conclusion

The instrument that we created could allow to assess the risk of bias in different kind of studies. Our assessment of the studies based on the criteria that we had set up in the instrument clearly identified that further research needs to be done due to the lack of unbiased studies regarding the use of biologic meshes for abdominal hernia repair.

Keywords

Biological mesh Abdominal wall hernia Bias Assessment Literature 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

For this type of study, formal consent is not required.

Human and animal rights

This article does not contain any studies with human participants or animals performed by any of the authors.

Informed consent

None.

References

  1. 1.
    Kim H, Bruen K, Vargo D (2006) Acellular dermal matrix in the management of high-risk abdominal wall defects. Am J Surg 192(6):705–709.  https://doi.org/10.1016/j.amjsurg.2006.09.003 Google Scholar
  2. 2.
    Beale EW, Hoxworth RE, Livingston EH, Trussler AP (2012) The role of biologic mesh in abdominal wall reconstruction: a systematic review of the current literature. Am J Surg 204(4):510–517.  https://doi.org/10.1016/j.amjsurg.2012.03.009 Google Scholar
  3. 3.
    Maurice SM, Skeete DA (2009) Use of human acellular dermal matrix for abdominal wall reconstructions. Am J Surg 197(1):35–42.  https://doi.org/10.1016/j.amjsurg.2007.11.019 Google Scholar
  4. 4.
    Huerta S, Varshney A, Patel PM, Mayo HG, Livingston EH (2016) Biological mesh implants for abdominal hernia repair: US Food and Drug Administration approval process and systematic review of its efficacy. JAMA Surg 151(4):374–381Google Scholar
  5. 5.
    Darehzereshki A, Goldfarb M, Zehetner J et al (2014) Biologic versus nonbiologic mesh in ventral hernia repair: a systematic review and meta-analysis. World J Surg. 38(1):40–50.  https://doi.org/10.1007/s00268-013-2232-1 Google Scholar
  6. 6.
    Edelman DS, Bellows CF (2010) Umbilical herniorrhaphy reinforced with biologic mesh. Am Surg 76(11):1205–1209.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  7. 7.
    Primus FE, Harris HW (2014) A critical review of biologic mesh use in ventral hernia repairs under contaminated conditions. Hernia 17(1):21–30.  https://doi.org/10.1007/s10029-012-1037-8.A Google Scholar
  8. 8.
    Bachman S, Ramshaw B (2008) Prosthetic material in ventral hernia repair: how do I choose? Surg Clin N Am 88(1):101–112.  https://doi.org/10.1016/j.suc.2007.11.001 Google Scholar
  9. 9.
    Shankaran V, Weber DJ, Reed RL, Luchette FA (2011) A review of available prosthetics for ventral hernia repair. Ann Surg 253(1):16–26.  https://doi.org/10.1097/SLA.0b013e3181f9b6e6 Google Scholar
  10. 10.
    Carey TS, Boden SD (2003) A critical guide to case series report. Spine (Phila Pa 1976) 28(15):1631–1634.  https://doi.org/10.1093/pubmed/fdl064 Google Scholar
  11. 11.
    Slim K, Nini E, Forestier D et al (2003) Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg 73:712–716Google Scholar
  12. 12.
    AHQR. Methods guide for effectiveness and comparative effectiveness reviews. AHRQ Publication No. 10(14)-EHC063-EF. 2014;(10). https://www.effectivehealthcare.ahrq.gov/ehc/products/60/318/CER-Methods-Guide-140109.pdf. Accessed 4 Feb 2019
  13. 13.
    Ferzoco SJ (2013) A systematic review of outcomes following repair of complex ventral incisional hernias with biologic mesh. Int Surg 98(4):399–408.  https://doi.org/10.9738/INTSURG-D-12-00002.1 Google Scholar
  14. 14.
    Catena F, Ansaloni L, Gazzotti F, Gagliardi S, Di Saverio S, D’Alessandro LPA (2007) Use of porcine dermal collagen graft (Permacol) for hernia repair in contaminated fields. Hernia 11(1):57–60.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  15. 15.
    Treviño JM, Franklin ME, Berghoff KR, Glass JL, Jaramillo EJ (2006) Preliminary results of a two-layered prosthetic repair for recurrent inguinal and ventral hernias combining open and laparoscopic techniques. Hernia 10(3):253–257.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  16. 16.
    Nemeth NL, Butler CE (2009) Complex torso reconstruction with human acellular dermal matrix: long-term clinical follow-up. Plast Reconstr Surg 123(1):192–196.  https://doi.org/10.1097/PRS.0b013e3181934812 Google Scholar
  17. 17.
    Gupta A, Zahriya K, Mullens PL, Salmassi S, Keshishian A (2006) Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. Hernia 10(5):419–425.  https://doi.org/10.1007/s10029-006-0130-2 Google Scholar
  18. 18.
    Ko JH, Salvay DM, Paul BC, Wang EC, Dumanian GA (2009) Soft polypropylene mesh, but not cadaveric dermis, significantly improves outcomes in midline hernia repairs using the components separation technique. Plast Reconstr Surg 124(3):836–847.  https://doi.org/10.1097/prs.0b013e3181b0380e Google Scholar
  19. 19.
    Scott BG, Welsh FJ, Pham HQ et al (2006) Early aggressive closure of the open abdomen. J Trauma 60(1):17–22.  https://doi.org/10.1097/01.ta.0000200861.96568.bb Google Scholar
  20. 20.
    Jin J, Rosen MJ, Blatnik J et al (2007) Use of acellular dermal matrix for complicated ventral hernia repair: does technique affect outcomes? J Am Coll Surg 205(5):654–660.  https://doi.org/10.1016/j.jamcollsurg.2007.06.012 Google Scholar
  21. 21.
    Rosen M. (2015). A prospective randomized trial of biologic mesh versus synthetic mesh for the repair of complex ventral hernias. Identification No: NCT02451176. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02451176#moreinfo
  22. 22.
    Ko JH (2009) Abdominal wall reconstruction. Arch Surg 144(211):1047–1055Google Scholar
  23. 23.
    Chavarriaga LF, Lin E, Losken A, Cook MW, Jeansonne LO, White BC, Sweeney JF, Galloway JR, Davis SS (2010) Management of complex abdominal wall defects using acellular porcine dermal collagen. Am Surg 76(1):96–100.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  24. 24.
    Shah BC, Tiwari MM, Goede MR, Eichler MJ, Hollins RR, McBride CL, Thompson JSO (2011) Not all biologics are equal! Hernia 15(2):165–171.  https://doi.org/10.1007/s10029-010-0768-7 Google Scholar
  25. 25.
    Brewer MB, Rada EM, Milburn ML, Goldberg NH, Singh DP, Cooper MSR (2011) Human acellular dermal matrix for ventral hernia repair reduces morbidity in transplant patients. Hernia 15(2):141–145.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  26. 26.
    Ghazi B, Deigni O, Yezhelyev M, Losken A (2011) Current options in the management of complex abdominal wall defects. Ann Plast Surg 66(5):488–492.  https://doi.org/10.1097/SAP.0b013e31820d18db Google Scholar
  27. 27.
    Raftopoulos ICA (2007) An outcome of laparoscopic ventral hernia repair in morbidly obese patients with a body mass index exceeding 35 kg/m2. Surg Endosc 21(12):2293–2297.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  28. 28.
    Sailes FC, Walls J, Guelig D et al (2010) Synthetic and biological mesh in component separation. Ann Plast Surg 64(5):1.  https://doi.org/10.1097/SAP.0b013e3181dc8409 Google Scholar
  29. 29.
    Tang R, Gu Y, Gong DQ, Qian YL (2009) Immediate repair of major abdominal wall defects after extensive tumor excision in patients with abdominal wall neoplasm: a prospective review of 27 cases. Ann Surg Oncol 16(10):2895–9265.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  30. 30.
    Vertrees A, Greer L, Pickett C et al (2008) Modern management of complex open abdominal wounds of war: a 5-year experience. J Am Coll Surg 207(6):801–809.  https://doi.org/10.1016/j.jamcollsurg.2008.08.014 Google Scholar
  31. 31.
    Holton LH, Kim D, Silverman RP, Rodriguez ED, Singh N, Goldberg NH (2005) Human acellular dermal matrix for repair of abdominal wall defects: the review of clinical experience and experimental data. J Long Term Eff Med Implants 15(5):547–558.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  32. 32.
    Lee EI, Chike-Obi CJ, Gonzalez P et al (2009) Abdominal wall repair using the human acellular dermal matrix: a follow-up study. Am J Surg 198(5):650–657.  https://doi.org/10.1016/j.amjsurg.2009.07.027 Google Scholar
  33. 33.
    Lipman J, Medalie D, Rosen MJ (2008) Staged repair of massive incisional hernias with loss of abdominal domain: a novel approach. Am J Surg 195(1):84–88.  https://doi.org/10.1016/j.amjsurg.2007.02.017 Google Scholar
  34. 34.
    Misra S, Raj PK, Tarr SM, Treat RC (2008) Results of AlloDerm use in abdominal hernia repair. Hernia 12(3):247–250.  https://doi.org/10.1007/s10029-007-0319-z Google Scholar
  35. 35.
    Singh MK, Rocca JP, Rochon C, Facciuto ME, Sheiner PA, Rodriguez-Davalos MI (2008) Open abdomen management with human acellular dermal matrix in liver transplant recipients. Transpl Proc 40(10):3541–3544.  https://doi.org/10.1016/j.transproceed.2008.06.105 Google Scholar
  36. 36.
    Hsu PW, Salgado CJ, Kent K et al (2009) Evaluation of porcine dermal collagen (Permacol) used in abdominal wall reconstruction. J Plast Reconstr Aesthet Surg 62(11):1484–1489.  https://doi.org/10.1016/j.bjps.2008.04.060 Google Scholar
  37. 37.
    Shaikh FM, Giri SK, Durrani S, Waldron DGP (2007) Experience with porcine acellular dermal collagen implant in a one-stage tension-free reconstruction of acute and chronic abdominal wall defects. World J Surg 31(10):1966–1972.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  38. 38.
    Diaz JJ, Guy J, Berkes MB, Guillamondegui OMR (2006) Acellular dermal allograft for ventral hernia repair in the compromised surgical field. Am Surg 72(12):1181–1187.  https://doi.org/10.1680/udap.2010.163 Google Scholar
  39. 39.
    Patton JH, Berry S, Kralovich KA (2007) Use of human acellular dermal matrix in complex and contaminated abdominal wall reconstructions. Am J Surg 193(3):360–363.  https://doi.org/10.1016/j.amjsurg.2006.09.021 Google Scholar
  40. 40.
    Candage R, Jones K, Luchette FA, Sinacore JM, Vandevender D, Reed RL (2008) Use of human acellular dermal matrix for hernia repair: friend or foe? Surgery 144(4):703–711.  https://doi.org/10.1016/j.surg.2008.06.018 Google Scholar
  41. 41.
    Blatnik J, Jin J, Rosen M (2008) Abdominal hernia repair with bridging acellular dermal matrix-an expensive hernia sac. Am J Surg 196(1):47–50.  https://doi.org/10.1016/j.amjsurg.2007.06.035 Google Scholar
  42. 42.
    Buinewicz B, Rosen B (2004) Acellular cadaveric dermis (AlloDerm): a new alternative for abdominal hernia repair. Ann Plast Surg 52(2):188–194.  https://doi.org/10.1097/01.sap.0000100895.41198.27 Google Scholar
  43. 43.
    Espinosa-de-Los-Monteros A, de la Torre JI, Marrero I, Andrades P, Davis MR, Vasconez LO (2007) Utilization of human cadaveric acellular dermis for abdominal hernia reconstruction. Ann Plast Surg 58(3):264–267.  https://doi.org/10.1097/01.sap.0000254410.91132.a8 Google Scholar
  44. 44.
    Lin HJ, Spoerke N, Deveney C, Martindale R (2009) Reconstruction of complex abdominal wall hernias using the acellular human dermal matrix: a single institution experience. Am J Surg 197(5):599–603.  https://doi.org/10.1016/j.amjsurg.2008.12.022 Google Scholar
  45. 45.
    Bellows CF, Albo D, Berger DH, Awad SS (2007) Abdominal wall repair using human acellular dermis. Am J Surg 194(2):192–198.  https://doi.org/10.1016/j.amjsurg.2006.11.012 Google Scholar
  46. 46.
    Kolker AR, Brown DJ, Redstone JS, Scarpinato VM, Wallack MK (2005) Multilayer reconstruction of abdominal wall defects with acellular dermal allograft (AlloDerm) and component separation. Ann Plast Surg 55(1):36–41.  https://doi.org/10.1097/01.sap.0000168248.83197.d4 (discussion 41–42) Google Scholar
  47. 47.
    Schuster R, Singh J, Safadi BY, Wren SM (2006) The use of acellular dermal matrix for contaminated abdominal wall defects: wound status predicts success. Am J Surg 192(5):594–597.  https://doi.org/10.1016/j.amjsurg.2006.08.017 Google Scholar
  48. 48.
    Helton WS, Fisichella PM, Berger R, Horgan S, Espat NJ, Abcarian H (2005) Short-term outcomes with small intestinal submucosa for a ventral abdominal hernia. Arch Surg 140(6):549–560.  https://doi.org/10.1001/archsurg.140.6.549 (discussion 560–562) Google Scholar
  49. 49.
    Parker DM, Armstrong PJ, Frizzi JD, North JH (2006) porcine dermal collagen (Permacol) for abdominal wall reconstruction. Curr Surg 63(4):255–258.  https://doi.org/10.1016/j.cursur.2006.05.003 Google Scholar
  50. 50.
    Limpert JN, Desai AR, Kumpf AL, Fallucco MA, Aridge DL (2009) Repair of abdominal wall defects with bovine pericardium. Am J Surg 198(5):e60–e65.  https://doi.org/10.1016/j.amjsurg.2009.01.027 Google Scholar

Copyright information

© Springer-Verlag France SAS, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of SurgeryWestchester Medical CenterValhallaUSA
  2. 2.Department of Surgery, Westchester Medical CenterNew York Medical CollegeValhallaUSA
  3. 3.Department of Surgery, Clinical Research UnitWestchester Medical CenterValhallaUSA
  4. 4.Section of Acute Care Surgery, Department of Surgery, Westchester Medical CenterNew York Medical CollegeValhallaUSA
  5. 5.Department of Surgery, Clinical Research UnitWestchester Medical CenterValhallaUSA
  6. 6.Department of Surgery, Clinical Research UnitWestchester Medical CenterValhallaUSA

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