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

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  • Adiela Correa Marinez
  • David Bock
  • Eva Carlsson
  • Charlotta Petersén
  • Sofia Erestam
  • Peter Kälebo
  • Rosenberg, Jacob
  • Eva Haglind
  • Eva Angenete

Aim: The 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. Methods: This 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. Results: Two 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. Conclusion: This 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.

OriginalsprogEngelsk
TidsskriftColorectal Disease
Vol/bind23
Udgave nummer5
Sider (fra-til)1091-1101
Antal sider11
ISSN1462-8910
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
The trial received funding from the Swedish Cancer Society number CAN2016/509, the Swedish Research Council 2017‐01103, Sahlgrenska University Hospital (ALF), ‘Agreement concerning research and education of doctors’ ALFGBF 366481, ALFGBG 716581, ALFGBG 493341, ALFGBG 426501, the Health and Medical Care Committee of the Regional Executive Board, Region Västra Götaland VGRFOU 384331, VGROU 475701 and VGRFOU 308311, the Swedish Society of Medicine (Bengt Ihres Fond), Knut and Alice Wallenberg's Foundation, and Anna‐Lisa and Bror Björnsson's Foundation. The funding sources had no influence on data acquisition, data management, analyses and interpretations of data or writing of the manuscript.

Publisher Copyright:
© 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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