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

Adiela Correa Marinez; Sofia Erestam; Eva Haglind; Jan Ekelund; Ulf Angerås; Jacob Rosenberg; Frederik Helgstrand; Eva Angenete

doi:10.1186/1745-6215-15-254

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

Adiela Correa Marinez, Sofia Erestam, Eva Haglind, Jan Ekelund, Ulf Angerås, Jacob Rosenberg, Frederik Helgstrand, Eva Angenete

Department of Clinical Medicine

11 Citations (Scopus)

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.

Original language	English
Article number	254
Journal	Trials
Volume	15
Pages (from-to)	1-7
Number of pages	7
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-15-254
Publication status	Published - 27 Jun 2014

Keywords

Clinical Protocols
Colostomy
Health Care Costs
Hernia, Abdominal
Humans
Length of Stay
Patient Readmission
Quality of Life
Research Design
Risk Factors
Surgical Mesh
Sweden
Time Factors
Tomography, X-Ray Computed
Treatment Outcome

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10.1186/1745-6215-15-254

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@article{2ff0f612fe044403b5032ddaa1a3dc76,

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

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 = "Clinical Protocols, Colostomy, Health Care Costs, Hernia, Abdominal, Humans, Length of Stay, Patient Readmission, Quality of Life, Research Design, Risk Factors, Surgical Mesh, Sweden, Time Factors, Tomography, X-Ray Computed, Treatment Outcome",

author = "{Correa Marinez}, Adiela and Sofia Erestam and Eva Haglind and Jan Ekelund and Ulf Anger{\aa}s and Jacob Rosenberg and Frederik Helgstrand and Eva Angenete",

year = "2014",

month = jun,

day = "27",

doi = "10.1186/1745-6215-15-254",

language = "English",

volume = "15",

pages = "1--7",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

}

TY - JOUR

T1 - Stoma-Const - the technical aspects of stoma construction

T2 - study protocol for a randomised controlled trial

AU - Correa Marinez, Adiela

AU - Erestam, Sofia

AU - Haglind, Eva

AU - Ekelund, Jan

AU - Angerås, Ulf

AU - Rosenberg, Jacob

AU - Helgstrand, Frederik

AU - Angenete, Eva

PY - 2014/6/27

Y1 - 2014/6/27

N2 - 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.

AB - 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.

KW - Clinical Protocols

KW - Colostomy

KW - Health Care Costs

KW - Hernia, Abdominal

KW - Humans

KW - Length of Stay

KW - Patient Readmission

KW - Quality of Life

KW - Research Design

KW - Risk Factors

KW - Surgical Mesh

KW - Sweden

KW - Time Factors

KW - Tomography, X-Ray Computed

KW - Treatment Outcome

U2 - 10.1186/1745-6215-15-254

DO - 10.1186/1745-6215-15-254

M3 - Journal article

C2 - 24970570

SN - 1745-6215

VL - 15

SP - 1

EP - 7

JO - Trials

JF - Trials

M1 - 254

ER -

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

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Keywords

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