The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Official Title: Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Study ID: NCT01865071
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Odense Universityhospital, Odense, Fyn, Denmark
Name: Mark Ellebæk, MD
Affiliation: Odense Universityhospital
Role: PRINCIPAL_INVESTIGATOR