Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
NCT ID: NCT01865071
Last Updated: 2014-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2011-09-30
2015-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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loop ileostomi
Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer
loop ileostomi
Interventions
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loop ileostomi
Eligibility Criteria
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Inclusion Criteria
* All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
* Written informed consent was obtained from all patients
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Mark Ellebaek Pedersen
Doctor
Principal Investigators
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Mark Ellebæk, MD
Role: PRINCIPAL_INVESTIGATOR
Odense Universityhospital
Locations
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Odense Universityhospital
Odense, Fyn, Denmark
Countries
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Central Contacts
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Facility Contacts
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Mark Ellebæk, MD
Role: primary
References
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Ellebaek MB, Perdawood SK, Steenstrup S, Khalaf S, Kundal J, Moller S, Bang JC, Stovring J, Qvist N. Early versus late reversal of diverting loop ileostomy in rectal cancer surgery: a multicentre randomized controlled trial. Sci Rep. 2023 Apr 10;13(1):5818. doi: 10.1038/s41598-023-33006-4.
Other Identifiers
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S-20110026
Identifier Type: -
Identifier Source: org_study_id
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