Trial reportTrials2014
Stoma-Const--the technical aspects of stoma construction: study protocol for a randomised controlled trial.
Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01694238 (Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Prosthetic mesh placement for the prevention of parastomal herniation.The Cochrane database of systematic reviews · 2018Pooled it
- Prophylactic mesh use during primary stoma formation to prevent parastomal hernia.Annals of the Royal College of Surgeons of England · 2017Pooled it
- Article
- Fascial incision shapes and paracolostomy hernia: cruciate vs. reinforced longitudinal (the "Hepworth hitch"): longcross randomized controlled trial (GECO2 STUDY).International journal of colorectal disease · 2025Article
- Ostomy-Related Complications.Clinics in colon and rectal surgery · 2019Review
- Technical Considerations in Stoma Creation.Clinics in colon and rectal surgery · 2017Review
- Parastomal hernia and prophylactic mesh use during primary stoma formation: a commentary.Hernia : the journal of hernias and abdominal wall surgery · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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/
designStoma-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 registrationClinicaltrials.gov, NCT01694238.2012-09-24.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.