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Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial

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Abstract

Background

Incisional hernias still are a major concern after laparotomy and are causing substantial morbidity. This study examines the feasibility, safety and incisional hernia rate of the use of a prophylactic intraperitoneal onlay mesh stripe (IPOM) to prevent incisional hernia following midline laparotomy.

Methods

This prospective, randomized controlled trial randomly allocated patients undergoing median laparotomy either to mass closure of the abdominal wall with a PDS-loop running suture reinforced by an intraperitoneal composite mesh stripe (Group A) or to the same procedure without the additional mesh stripe (Group B). Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. Secondary endpoints are were the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.

Results

A total of 267 patients were included in this study. Follow-up data 2 years after surgery was available from 210 patients (Group A = 107; Group B = 103). An incisional hernia was diagnosed in 18/107 (17%) patients in Group A and in 40/103 (39%) patients in Group B (p < 0.001). A surgical operation due to an incisional hernia was conducted for 12/107 (11%) patients in Group A and for 24/103 (23%) patients in Group B (p = 0.039). In both groups, minor and major complications as well as postoperative pain are reported with no statistically significant difference between the groups, even in contaminated situations.

Conclusions

This first randomized clinical trial indicates that the placement of a non-absorbable IPOM-stripe with prophylactic intention may significantly reduce the risk for a midline incisional hernia.

Trial registration

Ref. NCT01003067 (clinicaltrials.gov)

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Acknowledgements

The authors acknowledge support from Daniel Strub, MD (patient accrual), Pascal Kissling, MD (patient accrual and follow-up controls), and Marc Hauschild, MD (follow-up controls), Franziska Zumstein (study nurse, data management), Daniela Müller (study nurse, data management), and Leonie-Anastasia Wieland (data management).

Author information

Author notes

  1. Brosi Philippe and Glauser Philippe equally contributing.

Authors and Affiliations

  1. Department of Surgery, Hospital of Baselland, Affiliated to the University of Basel, Liestal, Switzerland

    Philippe Brosi, Philippe M. Glauser, Benjamin Speich, Samuel A. Käser & Christoph A. Maurer

  2. Department of General Surgery, University Hospital Basel, Basel, Switzerland

    Philippe M. Glauser

  3. Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland

    Benjamin Speich

  4. Department of Surgery and Transplantation, University Hospital Zürich, Zurich, Switzerland

    Philippe Brosi & Samuel A. Käser

  5. Surgical Department, Hirslanden Private Clinic Group, Clinic Beau-Site, Schänzlihalde 1, 3000, Bern, Switzerland

    Christoph A. Maurer

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  1. Philippe Brosi
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Corresponding author

Correspondence to Christoph A. Maurer.

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Conflict of interest

Brosi Philippe, MD, Glauser Philippe M., MD, Speich Benjamin, PhD, Käser Samuel A., MD, and Maurer Christoph A, MD have no conflicts of interest or financial ties to disclose.

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Brosi, P., Glauser, P.M., Speich, B. et al. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg 42, 1687–1694 (2018). https://doi.org/10.1007/s00268-017-4363-2

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