RANDOMIZED CONTROLLED TRIAL

Prophylactic Mesh Placement During Formation of an End-colostomy Reduces the Rate of Parastomal Hernia

Short-term Results of the Dutch PREVENT-trial

Brandsma, Henk-Thijs MD; Hansson, Birgitta M. E. MD, PhD; Aufenacker, Theo J. MD, PhD; van Geldere, Dick MD, PhD; Lammeren, Felix M. V. MD, PhD; Mahabier, Chander MD, PhD; Makai, Peter PhD; Steenvoorde, Pascal MD, PhD; de Vries Reilingh, Tammo S. MD, PhD; Wiezer, Marinus J. MD, PhD; de Wilt, Johannes H. W. MD, PhD; Bleichrodt, Robert P. MD, PhD; Rosman, Camiel MD, PhD On behalf of the Dutch Prevent Study group

Author Information

^*Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands

^†Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands

^‡Department of Surgery, Isala, Zwolle, the Netherlands

^§Department of Surgery, Slingeland Hospital, Doetinchem, the Netherlands

^¶Department of Surgery, Albert Schweitzer Hospital Dordrecht, Dordrecht, the Netherlands

^||Department for Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands

^**Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands

^††Department of Surgery, Elkerliek Hospital, Helmond, the Netherlands

^‡‡Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands

^§§Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.

Reprints: Henk-Thijs Brandsma, MD, Prevent Study group, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands. E-mail: [email protected].

Surgical Research Fund, Canisius Wilhelmina Hospital, Nijmegen: ZonMW, the Netherlands Organization for Health Research and Development, Project number 170991011; Covidien/Medtronic

All authors had complete access to the study data supporting the publication

The participating investigators collected data, provided, and cared for study patients. Jan A Charbon MD (Department of Surgery, Maxima Medical Centre, Veldhoven, the Netherlands); Michael F Gerhards MD, PhD (Department of Surgery, OLVG, Amsterdam, the Netherlands); Ignace HJT de Hingh MD, PhD (Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands); Pieter J Tanis MD, PhD (Department of Surgery, Amsterdam Medical Centre, Amsterdam, the Netherlands); Johan F Lange MD, PhD (Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands).

The authors have no conflict of interest.

The PREVENT-trial is registered at http://www.trialregister.nl/trialreg/admin/rctview.asp?TC2018.

Annals of Surgery 265(4):p 663-669, April 2017. | DOI: 10.1097/SLA.0000000000001903

Abstract

Objective:

The aim of this study was to investigate the incidence of parastomal hernias (PSHs) after end-colostomy formation using a polypropylene mesh in a randomized controlled trial versus conventional colostomy formation.

Background:

A PSH is the most frequent complication after stoma formation. Symptoms may range from mild abdominal pain to life-threatening obstruction and strangulation. The treatment of a PSH is notoriously difficult and recurrences up to 20% have been reported despite the use of mesh. This has moved surgical focus toward prevention.

Methods:

Augmentation of the abdominal wall with a retro-muscular lightweight polypropylene mesh was compared with the traditional formation of a colostomy. In total, 150 patients (1:1 ratio) were included. The incidence of a PSH, morbidity, mortality, quality of life, and cost-effectiveness was measured after 1 year of follow-up.

Results:

There was no difference between groups regarding demographics and predisposing factors for PSH. Three out of 67 patients (4.5%) in the mesh group and 16 out of 66 patients (24.2%) in the nonmesh group developed a PSH (P = 0.0011). No statistically significant difference was found in infections, concomitant hernias, SF-36 questionnaire, Von Korff pain score, and cost-effectiveness between both study groups.

Conclusion:

Prophylactic augmentation of the abdominal wall with a retromuscular lightweight polypropylene mesh at the ostomy site significantly reduces the incidence of PSH without a significant difference in morbidity, mortality, quality of life, or cost-effectiveness.

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Prophylactic Mesh Placement During Formation of an End-colostomy Reduces the Rate of Parastomal Hernia

Short-term Results of the Dutch PREVENT-trial