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

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.

NCT Number	NCT07111429
Lead Sponsor	Peking University Cancer Hospital & Institute Collaborators: Beijing Chao Yang Hospital, Peking University Third Hospital, Peking University First Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Beijing New Journey Cancer Hospital, Beijing Nanjiao Tumor Hospital, Xuanwu Hospital, Beijing, Beijing Hospital, Hebei medical college fourth hospital, China-Japan Union Hospital, Jilin University, Jiangsu Province people hospital, Jinzhou Medical University, Shanxi Province Cancer Hospital, Ruijin Hospital, Changhai Hospital, The Second Affiliated Hospital of Suzhou Medical University, Tianjin People's Hospital, Yantai Yuhuangding Hospital, First Affiliated Hospital of Zhejiang University, Zhejiang cancer University, China-Japan Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Affiliated Drum Tower Hospital, Nanjing University
Conditions	Complication,Postoperative, Stoma
Enrollment	5,000 participants
Start Date	2025-08-15
Primary Completion	2025-12-15 (estimated)
Study Completion	2025-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-08-08