Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）

Rectal Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194708
• Other study ID #: COCG-02
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: January 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year non-reversal rate of temporary stoma		1 year after ostomy