Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: stoma closure at different times choose different times to do stoma closure after surgery for rectal cancer |
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
|
Outcome Measures
Primary Outcome Measures
- Postoperative complication [within the first 2 weeks after surgery]
Secondary Outcome Measures
- Postoperative quality of life [five years]
- survival rate [five years]
- Disease-free survival [five years]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huashan Hospital Affiliated to Fudan University | Shanghai | China | 200040 |
Sponsors and Collaborators
- Huashan Hospital
Investigators
- Principal Investigator: Jianbin Xiang, doctor, Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- KY2015-276