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.
*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@example.com.
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.