Rectal Cancer Clinical Trial
Official title:
Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
The study is being conducted as a prospective randomized controlled multicenter study of
patients with a temporary ileostomy due to rectal cancer. The study will be conducted in
hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes
Group (www.ssorg.net).
The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead
of later reversal more than 12 weeks after surgery.
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 89 patients over an expected period of 4 years. Both groups are
examined for postoperative complications as well as stoma-related 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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