Early Closure of Protective Ileostomy in Rectal Cancer Patients

Study Overview
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Brief Summary
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The aim of the study was to compare the restoration of the GI tract by the closure of protective ileostomy after low anterior resection for rectal cancer after 14 days and more than 3 months.

Detailed Description
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The closure of the protective ileostomy created during the low anterior resection for rectal cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the gastrointestinal tract. It usually takes place several months after the primary surgery, because the patients starts chemotherapy and cannot undergo the procedure during the therapy. It results in the relative low quality of life of the patient, as well as often leads to complications. Therefore, it seem reasonable to close the stoma as soon as possible to take the burden off patient. It is well known that the healing process of the anastomosis runs in the three phases, but only two first are crucial for the clinical result. The second takes place between 5th and 14th postoperative day. Therefore it should be possible to perform successful restoration of the GI tract already after two weeks after operation, and not after many moths. The aim of the study was to compare the restoration of the GI tract after 14 days and more than 3 months, so to compare the traditional and early strategy.

Official Title
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The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Procedure: Closure of the ileostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 18 year old the presence of the protective ileostomy created during the low anterior resection to protect the colo-rectal anastomosis Exclusion Criteria: the presence of the protective ileostomy created during any other procedure than the low anterior resection to protect the colo-rectal anastomosis age < 18 yo

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: Early closure<br>Closure of the ileostomy 14 days after the primary operation, in which it was created. | Procedure: Closure of the ileostomy<br>* Surgical closure of the protective ileostomy (reconnection of intestinal loops)<br>|
| Active Comparator: Late closure<br>Closure of the ileostomy more than 90 days after the primary operation, in which it was created. | Procedure: Closure of the ileostomy<br>* Surgical closure of the protective ileostomy (reconnection of intestinal loops)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative fistulas | number of patients with the fistula of the anastomosis | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of anticancer therapy | Time to the beginning of adiuvant chemotherapy | 3 months after surgery |