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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07111429
Acronym
COCG-SITI
Enrollment
5000
Registered
2025-08-08
Start date
2025-08-15
Completion date
2025-12-15
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication,Postoperative, Stoma

Keywords

stoma complications, SITI-CD Classification

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.

Interventions

DIAGNOSTIC_TESTNovel 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.

Sponsors

Beijing Chao Yang Hospital
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
Peking University People's Hospital
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
Beijing New Journey Cancer Hospital
CollaboratorUNKNOWN
Beijing Nanjiao Tumor Hospital
CollaboratorUNKNOWN
Xuanwu Hospital, Beijing
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
Hebei medical college fourth hospital
CollaboratorUNKNOWN
China-Japan Union Hospital, Jilin University
CollaboratorOTHER
Jiangsu Province people hospital
CollaboratorUNKNOWN
Jinzhou Medical University
CollaboratorOTHER
Shanxi Province Cancer Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
Changhai Hospital
CollaboratorOTHER
The Second Affiliated Hospital of Suzhou Medical University
CollaboratorUNKNOWN
Tianjin People's Hospital
CollaboratorOTHER
Yantai Yuhuangding Hospital
CollaboratorOTHER
First Affiliated Hospital of Zhejiang University
CollaboratorOTHER
Zhejiang cancer University
CollaboratorUNKNOWN
China-Japan Friendship Hospital
CollaboratorOTHER
Sixth Affiliated Hospital, Sun Yat-sen University
CollaboratorOTHER
Affiliated Drum Tower Hospital, Nanjing University
CollaboratorUNKNOWN
Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with stoma after colorectal cancer resection.

Exclusion criteria

* Patients who don't want to be studied

Design outcomes

Primary

MeasureTime frameDescription
Incidence of stoma complications in different SITI grades1yearTo understand the complications of different SITI grades, to clarify the rationality and feasibility of SITI grades, and to provide reasonable treatment for patients.

Secondary

MeasureTime frameDescription
Current status of surgeons' cognition of stoma complications2022-08 till 2023-08To 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.
Global applicability of the SITI grades criteria2022-08 till 2023-08

Countries

China

Contacts

Primary ContactLIN WANG, MD
wanglinmd@foxmail.com+8613910975011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026