Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer

Detailed Description
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Since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. There is no valid data about the need of protective ileostomy in these patients. About 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. Aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. Therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. In the event of clinical impairment in the postoperative course CT scan with KM filling of the rectum to exclude insufficiency of the anastomosis will be performed. In case of insufficiency protective ileostomy will be created. 40 patients will be included. Comparison: Patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.

Official Title
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Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: protective ileostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: radical resectable rectal cancer low sphincter-preserving resection of carcinomas of the lower and middle third preoperative normal continence preoperative normal sphincter function complete rings after stapler anastomosis impermeability of anastomosis for air written informed consent Exclusion Criteria: reduced cooperation or drug abuse pregnancy psychosis age under 18 years

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

| Intervention/Treatment |
| --- |
|Procedure: protective ileostomy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality until day 30 postoperative |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Ranking of factors influencing quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, protective ileostomy, low anterior resection