Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: loop ileostomi

• Registration Number: NCT01865071
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2013-05-26
• Study First Posted: 2013-05-30
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All patients aged 18 years or older.
• All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
• Written informed consent was obtained from all patients

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
loop ileostomi	loop ileostomi	Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer

Primary Outcome Measures

Name	Time	Method
Mortality	Death occurring during the first 90 days	Death occurring during the first 90 postoperative days

Trial Locations

Locations (1)

Odense Universityhospital; 🇩🇰 Odense, Fyn, Denmark