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Surgical Endoscopy

, Volume 30, Issue 3, pp 1188–1197 | Cite as

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial

  • Maciej Pawlak
  • Ralf-Dieter Hilgers
  • Kamil Bury
  • Andrzej Lehmann
  • Radosław Owczuk
  • Maciej Śmietański
Article

Abstract

Background

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.

Methods

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.

Results

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).

Conclusions

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.

Keywords

Laparoscopic abdominal wall hernia repair Ventral hernia Incisional hernia Intraperitoneal onlay mesh 

Notes

Compliance with Ethical Standards

Disclosures

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.

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Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  • Maciej Pawlak
    • 1
    • 2
  • Ralf-Dieter Hilgers
    • 3
  • Kamil Bury
    • 2
  • Andrzej Lehmann
    • 1
  • Radosław Owczuk
    • 4
  • Maciej Śmietański
    • 5
  1. 1.Department of General SurgeryCeynowa HospitalWejherowoPoland
  2. 2.Department of Cardiac and Vascular SurgeryMedical University of GdańskGdańskPoland
  3. 3.Department of Medical StatisticsRWTH Aachen UniversityAachenGermany
  4. 4.Department of Anesthesiology and Intensive CareMedical University of GdańskGdańskPoland
  5. 5.II Department of RadiologyMedical University of GdańskGdańskPoland

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