Understanding why some temporary stomas for rectal cancer can't be reversed
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)
This study looks at why some people with temporary stomas after rectal cancer surgery can't have them reversed, to help understand the reasons and improve future outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 235 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06194708 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the reasons why some patients with mid-low rectal cancer who received temporary ostomies after surgery are unable to have them reversed. It will explore the proportion of non-reversible stomas and identify the main causes behind this issue. By collecting and analyzing patient data before and during surgery, the study seeks to develop a predictive model for stoma reversal timing and assess risk factors that may influence this outcome.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with pathologically confirmed rectal adenocarcinoma who have undergone radical resection and received a temporary ostomy.
Not a fit: Patients who initially had a permanent stoma or those with distant metastasis or multi-primary colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve patient outcomes by providing insights that lead to better management of temporary stomas in rectal cancer patients.
How similar studies have performed: While this study addresses a specific aspect of stoma management, similar observational studies have shown success in understanding postoperative outcomes in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.