NCT01865071

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

Detailed description

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer. Early closer is defined as postoperative days 8-12 and delayed as later then 3 months. Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma. A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation. If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed. Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection. Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered. LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	loop ileostomi

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-05-30
• Last updated: 2014-02-05

Locations

1 site across 1 country: Denmark