Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial
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Patients’ need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.
During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (p < 0.0001) and no difference after 7 days (p = 0. 7019). The pain intensity decreased significantly over time (p < 0.0001) and was significantly higher in the PH group (p < 0.0001).
Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.
KeywordsLaparoscopic abdominal wall hernia repair Ventral hernia Incisional hernia Intraperitoneal onlay mesh
Compliance with Ethical Standards
Maciej Śmietański on behalf of the World of Surge and Polish Hernia Study Group received consulting fees for serving on the Advisory Committee of Johnson & Johnson Medical Products (2008–2010) and financial support and honoraria by Ethicon Poland, Covidien Poland, Covimed Poland, Bard, Tricomed and W.L. Gore for speaking and teaching. Ralf-Dieter Hilgers, Drs Maciej Pawlak, Kamil Bury, Andrzej Lehmann and Radosław Owczuk have no conflicts of interest or financial ties to disclose.
- 4.Rogmark P, Petersson U, Bringman S, Eklund A, Ezra E, Sevonius D, Smedberg S, Osterberg J, Montgomery A (2013) Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg 258:37–45. doi: 10.1097/SLA.0b013e31828fe1b2 CrossRefPubMedGoogle Scholar
- 5.Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M (2011) Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev (3):CD007781. doi: 10.1002/14651858.CD007781.pub2
- 9.Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, Guleria S, Arora MK, Chabra A (2011) A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc 25:1431–1438. doi: 10.1007/s00464-010-1410-6 CrossRefPubMedGoogle Scholar
- 10.Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S (2010) Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc 24:1296–1302. doi: 10.1007/s00464-009-0763-1 PubMedCentralCrossRefPubMedGoogle Scholar
- 17.Szymczak C, Lubowiecka I (2010) Modeling of the fascia-mesh system and sensitivity analysis of a junction force after a laparoscopic ventral hernia repair. J Theor 48:933–950Google Scholar
- 18.Szymczak C, Lubowiecka I, Tomaszewska A, Smietański M (2012) Investigation of abdomen surface deformation due to life excitation: implications for implant selection and orientation in laparoscopic ventral hernia repair. Clin Biomech (Bristol, Avon) 27:105–110. doi: 10.1016/j.clinbiomech.2011.08.008 CrossRefGoogle Scholar
- 20.Szymczak C, Śmietański M (2012) Selected problems of laparoscopic ventral hernia repair—modeling and simulation. Alfa-Medica Press, GdańskGoogle Scholar
- 30.Eker H, Hansson B (2013) Laparoscopic vs open incisional hernia repair a randomized clinical trial. JAMA 148:259Google Scholar