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

Rectal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665026
• Other study ID #: KY2015-276
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2021
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 31, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. — View Citation

Tulchinsky H, Shacham-Shmueli E, Klausner JM, Inbar M, Geva R. Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? J Surg Oncol. 2014 Mar;109(3):266-9. doi: 10.1002/jso.23493. Epub 2013 Nov 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication		within the first 2 weeks after surgery
Secondary	Postoperative quality of life		five years
Secondary	survival rate		five years
Secondary	Disease-free survival		five years