Rectal Cancer
Conditions
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.
Interventions
PROCEDUREstoma 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
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complication | within the first 2 weeks after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative quality of life | five years |
| survival rate | five years |
| Disease-free survival | five years |
Countries
China
Outcome results
None listed