Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
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|ClinicalTrials.gov Identifier: NCT01865071|
Recruitment Status : Unknown
Verified February 2014 by Mark Ellebaek Pedersen, Odense University Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2013
Last Update Posted : February 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: loop ileostomi||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
Experimental: loop ileostomi
Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer
Procedure: loop ileostomi
- Mortality [ Time Frame: Death occurring during the first 90 days ]Death occurring during the first 90 postoperative days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865071
|Contact: Mark Ellebæk, MDfirstname.lastname@example.org|
|Odense, Fyn, Denmark, 5000|
|Contact: Mark Ellebæk, MD 004540880511|
|Principal Investigator:||Mark Ellebæk, MD||Odense Universityhospital|