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Open Access Study protocol

Stoma-Const - the technical aspects of stoma construction: study protocol for a randomised controlled trial

Adiela Correa Marinez1, Sofia Erestam12, Eva Haglind1, Jan Ekelund1, Ulf Angerås1, Jacob Rosenberg3, Frederik Helgstrand4 and Eva Angenete1*

Author Affiliations

1 Department of Surgery, Institute of Clinical Sciences, SSORG - Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital/Östra, 416 85 Gothenburg, Sweden

2 Department of Anaesthesia, Surgery and Intensive Care, Sahlgrenska University Hospital/Östra, SE-416 85 Gothenburg, Sweden

3 Department of Surgery, Herlev University Hospital, Copenhagen, Denmark

4 Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark

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Trials 2014, 15:254  doi:10.1186/1745-6215-15-254

Published: 27 June 2014

Abstract

Background

The construction of a colostomy is a common procedure, but the evidence for the different parts of the construction of the colostomy is lacking. Parastomal hernia is a common complication of colostomy formation. The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation (one including a mesh) regarding the development of parastomal hernia.

Methods/Design

Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation. The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year. Secondary endpoints are re-admission rate, postoperative complications (classified according to Clavien-Dindo), stoma-related complications (registered in the case record form at stoma care nurse follow-up), total length of hospital stay during 12 months, health-related quality of life and health economic analysis as well as re-operation rate and mortality within 30 days and 12 months of primary surgery. Follow-up is scheduled at 4-6 weeks, and 6 and 12 months. Inclusion is set at 240 patients.

Discussion

Parastomal hernia is a common complication after colostomy formation. Several studies have been performed with the aim to reduce the rate of this complication. However, none are fully conclusive and data on quality of life and health economy are lacking. The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment.

Trial registration

Clinicaltrials.gov, NCT01694238.2012-09-24.

Keywords:
Parastomal hernia; Colostomy; Mesh; Prevention