Clinical trial NCT02665026: Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complication
timeFrame: within the first 2 weeks after surgery
Secondary outcomes:
measure: Postoperative quality of life
timeFrame: five years
measure: survival rate
timeFrame: five years
measure: Disease-free survival
timeFrame: five years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
affiliation: Huashan Hospital
name: Jianbin Xiang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl 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. doi: 10.1097/SLA.0b013e3180603024.
citation: 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. doi: 10.1097/01.sla.0000133083.54934.ae.
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.