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

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)

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 Overview

• Status: Recruiting
• Conditions: Rectal Cancer

• Study Type: Observational
• Enrollment (Estimated): 235

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xiao Yi; Phone Number: +86 13366036387; Email: xiaoy@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In-hospital rectal cancer patients who underwent radical resection of the primary lesion

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mid-low rectal cancer patients with temporary stoma after radical surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year non-reversal rate of temporary stoma	1 year after ostomy

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: COCG-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No