Early Closure of Temporary Ileostomy
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Standard reversal of temporary ileostomyProcedure: Early reversal of temporary ileostomy
- Registration Number
- NCT01287637
- Lead Sponsor
- Herlev Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- 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
- Patients whose stoma is not reversible
- Patients with diabetes
- Patients being treated with Steroids
- Patients with communicative problems
- Patients with expected compliance issues
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Standard reversal of temporary ileostomy Standard reversal of temporary ileostomy Early reversal group Early reversal of temporary ileostomy Early reversal of temporary ileostomy
- Primary Outcome Measures
Name Time Method Postsurgical morbidity 6 months after inclusion Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Postsurgical morbidity. 12 months after inclusion- Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
- Secondary Outcome Measures
Name Time Method Socio-economic effect of early reversal of temporary ileostomy The investigators assess and analyze the economic effect 12 months after inclusion The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.
Quality of life Quality of life is assessed at 12 months after inclusion Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Trial Locations
- Locations (1)
Herlev Hospital, University of Copenhagen
🇩🇰Herlev, Denmark