Back to resultsEffectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stoma closure at different times
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
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
Sites / Locations
- Huashan Hospital Affiliated to Fudan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stoma closure at different times
Arm Description
choose different times to do stoma closure after surgery for rectal cancer
Outcomes
Primary Outcome Measures
Postoperative complication
Secondary Outcome Measures
Postoperative quality of life
survival rate
Disease-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02665026
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stoma closure at different times
Arm Type
Experimental
Arm Description
choose different times to do stoma closure after surgery for rectal cancer
Intervention Type
Procedure
Intervention Name(s)
stoma closure at different times
Intervention Description
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 Outcome Measure Information:
Title
Postoperative complication
Time Frame
within the first 2 weeks after surgery
Secondary Outcome Measure Information:
Title
Postoperative quality of life
Time Frame
five years
Title
survival rate
Time Frame
five years
Title
Disease-free survival
Time Frame
five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianbin Xiang, doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
Citations:
PubMed Identifier
17667498
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.
Results Reference
background
PubMed Identifier
15273542
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.
Results Reference
background
PubMed Identifier
24249401
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.
Results Reference
background
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Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
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