Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Study Overview
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Brief Summary
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Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

Detailed Description
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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.

Official Title
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Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: loop ileostomi


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: loop ileostomi<br>Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer | Procedure: loop ileostomi<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death occurring during the first 90 postoperative days | Death occurring during the first 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, rectal resection, proctectomy, stoma closure, rectal cancer