Stoma-Const--the technical aspects of stoma construction: study protocol for a randomised controlled trial. 2014

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

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

UI MeSH Term Description Entries
D007902 Length of Stay The period of confinement of a patient to a hospital or other health facility. Hospital Stay,Hospital Stays,Stay Length,Stay Lengths,Stay, Hospital,Stays, Hospital
D010359 Patient Readmission Subsequent admissions of a patient to a hospital or other health care institution for treatment. Hospital Readmission,Rehospitalization,Unplanned Hospital Readmissions,Unplanned Readmission,30 Day Readmission,Hospital Readmissions,Readmission, Hospital,Readmissions, Hospital,Thirty Day Readmission,30 Day Readmissions,Hospital Readmission, Unplanned,Hospital Readmissions, Unplanned,Readmission, Patient,Readmission, Thirty Day,Readmission, Unplanned,Rehospitalizations,Thirty Day Readmissions,Unplanned Hospital Readmission,Unplanned Readmissions
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D002985 Clinical Protocols Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy. Protocols, Clinical,Research Protocols, Clinical,Treatment Protocols,Clinical Protocol,Clinical Research Protocol,Clinical Research Protocols,Protocol, Clinical,Protocol, Clinical Research,Protocols, Clinical Research,Protocols, Treatment,Research Protocol, Clinical,Treatment Protocol
D003125 Colostomy The surgical construction of an opening between the colon and the surface of the body. Colostomies
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012307 Risk Factors An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent. Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D013526 Surgical Mesh Any woven or knit material of open texture used in surgery for the repair, reconstruction, or substitution of tissue. The mesh is usually a synthetic fabric made of various polymers. It is occasionally made of metal. Mesh, Surgical,Meshes, Surgical,Surgical Meshes
D013548 Sweden Country in northern Europe, bordering the Baltic Sea, between Finland and Norway. The capital is Stockholm.

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