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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Complication,Postoperative; Stoma
• Intervention / Treatment: Diagnostic test: Novel severity grading system of stoma-related complication in cancer patients

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: LIN WANG, MD; Phone Number: +8613910975011; Email: wanglinmd@foxmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
      • Contact: Lin Wang, MD; Phone Number: +86 139 1097 5011
      • Sub-Investigator: Lin Wang, M.D.

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with colostomy after bowel cancer surgery were followed up for one year to understand the type and occurrence time of the complications of colostomy. Patients who were unwilling to accept the study were excluded

Description

Inclusion Criteria:

• Patients with stoma after colorectal cancer resection.

Exclusion Criteria:

• Patients who don't want to be studied

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SITI-CD Classification of Stoma-related Complication in cancer patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stoma complications in different SITI grades	To understand the complications of different SITI grades, to clarify the rationality and feasibility of SITI grades, and to provide reasonable treatment for patients.	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current status of surgeons' cognition of stoma complications	To understand the current situation of stoma complications in cancer patients, and to standardize the cognition of stoma classification among surgeons.It includes the classification criteria and treatment methods of stoma.	2022-08 till 2023-08
Global applicability of the SITI grades criteria		2022-08 till 2023-08

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Peking University First Hospital; Changhai Hospital; Shanxi Province Cancer Hospital; Peking University People's Hospital; Peking Union Medical College Hospital; Peking University Third Hospital; Xuanwu Hospital, Beijing; Ruijin Hospital; First Affiliated Hospital of Zhejiang University; Beijing Chao Yang Hospital; Beijing Hospital; China-Japan Friendship Hospital; Sixth Affiliated Hospital, Sun Yat-sen University; China-Japan Union Hospital, Jilin University; Yantai Yuhuangding Hospital; Tianjin People's Hospital; Jinzhou Medical University; Beijing New Journey Cancer Hospital; Beijing Nanjiao Tumor Hospital; Hebei medical college fourth hospital; Jiangsu Province people hospital; The Second Affiliated Hospital of Suzhou Medical University; Zhejiang cancer University; Affiliated Drum Tower Hospital, Nanjing University
• Investigators: Principal Investigator: LIN WANG, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: August 1, 2025
• First Submitted That Met QC Criteria: August 1, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: stoma complications; SITI-CD Classification
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: PekingUCHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Based on SITI classification, we will decide whether to conduct multicenter study or not

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No