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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-04

Study Completion Date

2021-03-31

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.

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stoma closure at different times

choose different times to do stoma closure after surgery for rectal cancer

Group Type EXPERIMENTAL

stoma closure at different times

Intervention Type PROCEDURE

Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer

Interventions

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stoma closure at different times

Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No