Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical resection of rectal carcinoma). This study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

Detailed Description
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A temporary stoma may, in fact, result in reduced quality of life because of feelings of physical and mental restriction, debilitating nuisance, among other problems. Skin irritation, prolapse, and retractionare quite common after ileostomy. A high incidence of parastomal hernia, ileus, and increased salt and fluid loss has been reported, which may also contribute to greater willingness of both the surgeon and patient to close the temporary stoma as soon as possible. Currently, it remains unclear whether stoma closure should be performed after the end of chemotherapy or during chemotherapy (12 weeks or 24 weeks after radical resection of rectal carcinoma). The aim of this study is to assess the possible impact of stoma closure timing on postoperative results and to evaluate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

Official Title
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A Single Center, Open, Randomized Clinical Trials, Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Total Mesorectal Excision for Middle and Low Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: stoma closure at different times


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sign the informed consent postoperative pathology is rectal adenocarcinoma primary middle and low rectal cancer patients (tumor distance from the anal margin is less than 10 cm) underwent total mesorectal excision for rectal cancer with preventive loop ileostomy Exclusion Criteria: postoperative pathology is not rectal adenocarcinoma (rectal neuroendocrine tumor, lymphoma, etc.) postoperative pathologic staging of rectal cancer is I phase, II phase underwent total mesorectal excision for rectal cancer without preventive loop ileostomy emergency operation for rectal cancer disease progression (local recurrence or distant metastasis, etc.) anastomotic stenosis serious system disease, including heart dysfunction, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases participate in other clinical trial pregnancy or perinatal woman combined with other malignant tumor with a history of neurological and psychiatric disorders patients with abnormal bone marrow suppression after chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stoma closure at different times<br>choose different times to do stoma closure after surgery for rectal cancer | Procedure: stoma closure at different times<br>* Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication |  | within the first 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of life |  | five years | 
| survival rate |  | five years | 
| Disease-free survival |  | five years |