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NCT07111429

Chinese Ostomy Collaboration Group (COCG) Clinical Study -SITI Classification

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

Colorectal cancer is an important cancer worldwide, and its incidence is increasing year by year. A large proportion of patients may require diverting stoma or even permanent stoma after surgery. Some of these patients will have a variety of stoma-related complications, which seriously affect the quality of life of patients. At present, the mainstream postoperative complication classification is the traditional CD classification, which is suitable for the classification of most postoperative complications. However, due to the unique anatomical characteristics of patients with stoma, the current CD classification system may not be suitable for the classification of patients with stoma-related complications. Therefore, we plan to establish a registry database of colorectal cancer patients with stoma, explore the attribution and incidence of stoma-related complications, and propose a new improved classification system, the SITI classification, on the existing CD classification, for verification and promotion.

Official title: Evaluation of a Modified Clavien-Dindo Classification (COCG) of Stoma Complication in Cancer Patients: a Prospective, Registry-based, Non-randomized Trial (COCG-01 Trial) on Behalf of Chinese Ostomy Collaboration Group

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2025-08-15

Completion Date

2025-12-15

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Novel severity grading system of stoma-related complication in cancer patients

Over 5000 stoma patients treated at 26 centers between 2022 and 2023 were classified according to SITI-CD Classification.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China