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A Randomized Trial on the Technical Aspects of Stoma Construction.

NCT01694238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2019-03-29

No results posted yet for this study

Summary

An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included.

The three groups for randomization are:

A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months.

Conditions

  • Colostomy
  • Colorectal Neoplasm
  • Diverticulitis

Interventions

PROCEDURE

Cruciate incision

PROCEDURE

Circular incision

OTHER

Mesh enforced cruciate incision

Sponsors & Collaborators

  • The Swedish Society of Medicine

    collaborator OTHER

  • The Swedish agreement concerning research and education of doctors

    collaborator UNKNOWN

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Eva Angenete, M.D., Ph.D. · Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University and SSORG - Scandinavian Surgical Outcomes Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-09-30
Completion
2018-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694238 on ClinicalTrials.gov