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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
3 months after inclusion
Jacob Rosenberg, Professor
Herlev Hospital, University of Copenhagen
Denmark: Danish Dataprotection Agency