NCT02665026

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2016-01-04
• Primary completion: 2021-03-22
• Completion: 2021-03-31
• First posted: 2016-01-27
• Last updated: 2021-09-21

Locations

1 site across 1 country: China