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NCT Number: NCT07111429

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location contact

Lin Wang, M.D.

SUB_INVESTIGATOR

Lin Wang, MD

CONTACT

+86 139 1097 5011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with stoma after colorectal cancer resection.

Exclusion criteria

  • Patients who don't want to be studied

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Incidence of stoma complications in different SITI grades

    Time frame: 1year

    To understand the complications of different SITI grades, to clarify the rationality and feasibility of SITI grades, and to provide reasonable treatment for patients.

Secondary outcomes

  1. Current status of surgeons' cognition of stoma complications

    Time frame: 2022-08 till 2023-08

    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.

  2. Global applicability of the SITI grades criteria

    Time frame: 2022-08 till 2023-08

Study contacts

Contact information is provided by the study sponsor or research team.

LIN WANG, MD

CONTACT

[email protected]

+8613910975011

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

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

Registry information

Official study 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

Acronym: COCG-SITI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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