NCT01287637

Early Closure of Temporary Ileostomy

Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Early reversal of temporary ileostomy	Temporary ileostomy is reversed 8-13 days after the primary surgery
PROCEDURE	Standard reversal of temporary ileostomy	Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2011-02-01
• Last updated: 2016-01-20

Locations

1 site across 1 country: Denmark