Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

Study Overview
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Brief Summary
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The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.

Detailed Description
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In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.

Official Title
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Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Ileostomy closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anastomosis ≤ 5cm from anal verge age >18 years informed consent uneventful course after first operation Exclusion Criteria: pregnancy allergy to contrast agent severe non-surgical complications evident abdominal - pelvic complications

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 weeks<br>Ileostomy closure after 2 weeks | Procedure: Ileostomy closure<br>* Ileostomy closure at a different time point<br>|
| Experimental: 12 weeks<br>Ileostomy closure after 12 weeks | Procedure: Ileostomy closure<br>* Ileostomy closure at a different time point<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Of Life (GQLI - Questionnaire) | Quality Of Life Survey using the GQLI - Questionnaire | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (via Visual Analogue Scale) | Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter | intraoperatively | 
| Safety as assessed by Morbidity, Mortality | Morbidity, Mortality | 6 weeks, 16 weeks | 
| Quality Of Life (EORTC - Questionnaire) | Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire | preoperative (preOP), 6 weeks, 16 weeks | 
| Quality Of Life (GQLI - Questionnaire) | Quality Of Life Survey using the GQLI - Questionnaire | preOP, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, feasibility, safety, protective ileostomy closure