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

NCT ID: NCT07111429

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2025-12-15

Brief 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.

Detailed Description

The complications related to stoma can be divided into five categories: skin complications near stoma (SKIN), abdominal incision complications at stoma (INCISION), abdominal wall fascia tunnel complications (abdominal Fascia/Muscular Tunnel complications), intestinal and mesenteric complications（Intestine）, and functional complications of ileostomy (Dehydration after IL). According to the actual situation of colostomy patients, the SITI classification is proposed to classify the complications from Grade Ia to V. The specific classification is as follows: Grade Ia, only need to observe, no treatment. Grade Ib, non-invasive treatment is required, and no drug is used. Grade IIa, invasive treatment without anesthesia, such as filling or local medication. Grade IIb, except for Grade IIa treatment, drugs, antibiotics, blood transfusion, etc. are used throughout the body. Grage IIIa, requiring intervention under local anesthesia. Grade IIIb, requiring intervention treatment of general anesthesia. Grade IVa, life threatening complications, including dialysis and single organ dysfunction. Grade IVb, complication of multiple organ dysfunction. Grade V, patient died. Classification, classification and grading can help ostomy therapists effectively identify and manage ostomy complications. The establishment of the database is convenient for researchers to explore the attribution of complications and the incidence of various types of complications.

Conditions

Complication,Postoperative; Stoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SITI-CD Classification of Stoma-related Complication in cancer patients

SITI-CD Classification of Stoma-related Complication in cancer patients

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with stoma after colorectal cancer resection.

Exclusion Criteria

• Patients who don't want to be studied

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Beijing New Journey Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Beijing Nanjiao Tumor Hospital

UNKNOWN

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Hebei medical college fourth hospital

UNKNOWN

Sponsor Role: collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role: collaborator

Jiangsu Province people hospital

UNKNOWN

Sponsor Role: collaborator

Jinzhou Medical University

OTHER

Sponsor Role: collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Suzhou Medical University

UNKNOWN

Sponsor Role: collaborator

Tianjin People's Hospital

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Zhejiang cancer University

UNKNOWN

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Affiliated Drum Tower Hospital, Nanjing University

UNKNOWN

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Xiaokang Lei

Professor of Surgery, Chief physician, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LIN WANG

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

LIN WANG, MD

Role: CONTACT

wanglinmd@foxmail.com

+8613910975011

Facility Contacts

Lin Wang, MD

Role: primary

+86 139 1097 5011

Other Identifiers

PekingUCHI

Identifier Type: -

Identifier Source: org_study_id