• Colorectal Dis · May 2021

    Randomized Controlled Trial Multicenter Study

    Stoma-related complications: a report from the Stoma-Const randomized controlled trial.

    • Correa MarinezAdielaAhttps://orcid.org/0000-0002-2236-2294Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Gothenburg, Sweden.Department of Surgery, Region, David Bock, Eva Carlsson, Charlotta Petersén, Sofia Erestam, Peter Kälebo, Jacob Rosenberg, Eva Haglind, and Eva Angenete.
    • Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Gothenburg, Sweden.
    • Colorectal Dis. 2021 May 1; 23 (5): 1091-1101.

    AimThe impact of construction techniques on the development of stoma complications is partly undiscovered. The aim of this paper was to report and analyse the impact of the three surgical techniques in a randomized controlled trial Stoma-Const on stoma-related complications as well as identifying risk factors and patient-reported stoma function as a planned secondary analysis.MethodsThis was a randomized, multicenter trial where all patients scheduled to receive an end colostomy were invited to participate. Patients were randomized to one of three techniques for stoma construction; cruciate fascial incision, circular incision or prophylactic mesh. Stoma complications were assessed by a surgeon and stoma care nurses within 1 year postoperatively.ResultsTwo hundred and nine patients were randomized. Patient demographics were similar in all three groups. Data on stoma-related complications were available for analysis in 201 patients. A total of 127 patients (63%) developed some type of stoma complication within 1 year after surgery. The risk ratio (95% CI) for stoma complications was 0.93 (0.73; 1.2) between cruciate vs. circular incision groups and 1.02 (0.78; 1.34) between cruciate vs. mesh groups. There were no statistically significant differences between the groups regarding parastomal hernia rate and no risk factors could be identified.ConclusionThis randomized trial confirmed a high prevalence of stoma-related complications but could not identify an impact of surgical technique or identify modifiable risk factors for stoma-related complications.© 2020 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.

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