Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
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 postoperativday 8-12 and delayed as later then 3 month.
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 anastomisis in all patients. The patients will be randomized after the
"intention-to-treat" principelle, 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 peristomial dermitis,
dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Death occurring during the first 90 postoperative days
Death occurring during the first 90 days
Mark Ellebæk, MD
Denmark: Danish Dataprotection Agency