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Completed

NCT Number: NCT02665026

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stoma closure at different times

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

Primary outcomes

  1. Postoperative complication

    Time frame: within the first 2 weeks after surgery

Secondary outcomes

  1. Postoperative quality of life

    Time frame: five years

  2. survival rate

    Time frame: five years

  3. Disease-free survival

    Time frame: five years

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2016
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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