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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with stoma after colorectal cancer resection.

Disqualifiers

Patients who don't want to be studied

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: SITI-CD Classification of Stoma-related Complication in cancer patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1year

Secondary outcomes

1

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.

Time frame
2022-08 till 2023-08
2

Global applicability of the SITI grades criteria

Time frame
2022-08 till 2023-08

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Cancer Hospital & Institute

Lead sponsor

Beijing Chao Yang Hospital

Collaborator

Peking University Third Hospital

Collaborator

Peking University First Hospital

Collaborator

Peking University People's Hospital

Collaborator

Peking Union Medical College Hospital

Collaborator

Beijing New Journey Cancer Hospital

Collaborator

Beijing Nanjiao Tumor Hospital

Collaborator

Xuanwu Hospital, Beijing

Collaborator

Beijing Hospital

Collaborator

Hebei medical college fourth hospital

Collaborator

China-Japan Union Hospital, Jilin University

Collaborator

Jiangsu Province people hospital

Collaborator

Jinzhou Medical University

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Ruijin Hospital

Collaborator

Changhai Hospital

Collaborator

The Second Affiliated Hospital of Suzhou Medical University

Collaborator

Tianjin People's Hospital

Collaborator

Yantai Yuhuangding Hospital

Collaborator

First Affiliated Hospital of Zhejiang University

Collaborator

Zhejiang cancer University

Collaborator

China-Japan Friendship Hospital

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborator

Affiliated Drum Tower Hospital, Nanjing University

Collaborator

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