Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
18 Years
N/A
Both
Rectal Cancer
Trial Information
Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
After creation of the temporary ileostomy patients are included and are randomized to two
groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma
creation and will be compared to patients in the control group where the stoma is closed
after a minimum of 12 weeks (standard treatment in Denmark and Sweden).
Before randomization the eligible patients undergo a CT of the rectum to visualise the
anastomosis and possible leakage. Furthermore, the local investigators may choose to
supplement the CT with a rectoscopy.
The research group includes 200 patients over an expected period of 1 year. Both groups are
examined for postoperative complications at discharge and 3, 6 and 12 months after stoma
creation.
The research group also examines the impact on patients´ health-related quality of life at
3, 6 and 12 months after stoma creation.
Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12
months after stoma creation.
An interim analysis is planned for safety as well as recalculation of statistical power.
Inclusion Criteria:
- Patients with a temporary ileostomy after low anterior resection because of rectal
cancer
- Patients, who are physically and mentally fit to undergo surgery within 8-13 days
Exclusion Criteria:
- Patients whose stoma is not reversible
- Patients with diabetes
- Patients being treated with Steroids
- Patients with communicative problems
- Patients with expected compliance issues
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Postsurgical morbidity
Outcome Description:
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Outcome Time Frame:
3 months after inclusion
Safety Issue:
Yes
Principal Investigator
Jacob Rosenberg, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Herlev Hospital, University of Copenhagen
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
AKD03
NCT ID:
NCT01287637
Start Date:
February 2011
Completion Date:
August 2014
Related Keywords:
- Rectal Cancer
- Rectal cancer
- Temporary ileostomy
- Ealy reversal
- Morbidity
- Mortality
- Quality of life
- Economic effect
- Rectal Neoplasms
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