NCT06194708RecruitingNot Applicable
Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）on Behalf of Chinese Ostomy Collaboration Group (COCG-02)
Peking Union Medical College Hospital1 site in 1 country235 target enrollmentStarted: May 15, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 235
- Locations
- 1
- Primary Endpoint
- 1-year non-reversal rate of temporary stoma
Study Overview
Brief Summary
The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are:
- To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and their main causes.
- To use the basic information we collected from patients before and during surgery to develop an individualized model for predicting the time of stoma reversal and explore the risk factors affecting stoma reversal.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically confirmed as rectal adenocarcinoma;
- •The tumor is located within 12cm from the anal verge;
- •Primary tumor is radically resected;
- •The patient received a temporary ostomy during the in-hospital visit of the resection of the primary tumor.
Exclusion Criteria
- •The stoma was initially recognized as permanent stoma;
- •Patients with distant metastasis;
- •Patients with multi-primary colorectal cancer.
Outcomes
Primary Outcomes
1-year non-reversal rate of temporary stoma
Time Frame: 1 year after ostomy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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