A Randomized Trial on the Technical Aspects of Stoma Construction.

This study is currently recruiting participants.
Verified January 2014 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborators:
The Swedish Society of Medicine
The Swedish agreement concerning research and education of doctors
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01694238
First received: September 24, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Colostomy
Colorectal Neoplasm
Diverticulitis
Procedure: Cruciate incision
Procedure: Circular incision
Other: Mesh enforced cruciate incision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Stoma hernia frequency at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The frequency of stoma hernia at 12 months measured either by clinical examination or CT scan


Secondary Outcome Measures:
  • Readmission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of readmissions in the two groups

  • Postoperative infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Postoperative infections at 12 months

  • Total hospital stay [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The total number of days in hospital during 12 months

  • Other complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number and type of complications during 12 months postoperatively

  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    30 day mortality


Estimated Enrollment: 240
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cruciate incision
Cruciate incision in the abdominal wall fascia
Procedure: Cruciate incision
Experimental: Circular incision
Circular incision in the fascia
Procedure: Circular incision
Experimental: Mesh enforced cruciate incision
Mesh enforcement and then cruciate incision in the abdominal wall fascia
Other: Mesh enforced cruciate incision

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presenting with a cancer or other conditions for which an elective surgical procedure is planned and includes a permanent colostomy formation
  • possible to operate in regard to concomitant disease
  • giving informed consent to participate

Exclusion Criteria:

  • Not possible to operate due to concomitant disease
  • Participation in other randomized trials in conflict with the protocol and end-points of the Stoma-Const trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694238

Contacts
Contact: Eva Angenete, M.D, Ph.D. 46313438410 eva.angenete@vgregion.se
Contact: Adiela Correa Marinez, M.D. 46313434000 adiela-adriana.correa-marinez@vgregion.se

Locations
Sweden
Sahlgrenska University Hospital/östra Recruiting
Gothenburg, Sweden, 41685
Sub-Investigator: Adiela Correa Marinez, M.D.         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
The Swedish Society of Medicine
The Swedish agreement concerning research and education of doctors
Investigators
Principal Investigator: Eva Angenete, M.D., Ph.D. Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University and SSORG - Scandinavian Surgical Outcomes Research Group
  More Information

Additional Information:
No publications provided

Responsible Party: Eva Angenete, M.D., Ph.D., senior consultant surgeon, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01694238     History of Changes
Other Study ID Numbers: Stoma-Const
Study First Received: September 24, 2012
Last Updated: January 10, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Colostomy
Surgical technique

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Diverticulitis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on April 17, 2014