Complication,PostoperativeCOCG-SITINCT07111429
Chinese Ostomy Collaboration Group (COCG) Clinical Study -SITI Classification
An observational study of Complication,Postoperative and Stoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complication,Postoperative, Stoma
- What is being tested?
- Novel severity grading system of stoma-related complication in cancer patients
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 15 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with stoma after colorectal cancer resection.
Who cannot join
- Patients who don't want to be studied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Wang, MD, +86 139 1097 5011
Lin Wang, M.D.
About this study
Official 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
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.
Read the 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
- Being tested
- Novel severity grading system of stoma-related complication in cancer patients
- Keywords
- stoma complications, SITI-CD Classification
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel severity grading system of stoma-related complication in cancer patientsDiagnostic test
Over 5000 stoma patients treated at 26 centers between 2022 and 2023 were classified according to SITI-CD Classification.
| Study group | Role | What they receive |
|---|---|---|
| SITI-CD Classification of Stoma-related Complication in cancer patients | SITI-CD Classification of Stoma-related Complication in cancer patients Receives: Diagnostic Test: Novel severity grading system of stoma-related complication in cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year
Secondary outcomes (2)
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.
Measured: 2022-08 till 2023-08
Global applicability of the SITI grades criteria
Measured: 2022-08 till 2023-08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University Third Hospital, Peking University First Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Beijing New Journey Cancer Hospital, Beijing Nanjiao Tumor Hospital, Xuanwu Hospital, Beijing, Beijing Hospital, Hebei medical college fourth hospital, China-Japan Union Hospital, Jilin University, Jiangsu Province people hospital, Jinzhou Medical University, Shanxi Province Cancer Hospital, Ruijin Hospital, Changhai Hospital, The Second Affiliated Hospital of Suzhou Medical University, Tianjin People's Hospital, Yantai Yuhuangding Hospital, First Affiliated Hospital of Zhejiang University, Zhejiang cancer University, China-Japan Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Affiliated Drum Tower Hospital, Nanjing University
- Responsible party
- Principal investigator, Xiaokang Lei, Peking University Cancer Hospital & Institute
- Investigators
- LIN WANG, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111429
- Sponsor's protocol ID
- PekingUCHI
- Acronym
- COCG-SITI
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Based on SITI classification, we will decide whether to conduct multicenter study or not
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07111429
- Acronym / sponsor ID
- COCG-SITI / PekingUCHI
- Conditions
- Complication,Postoperative, Stoma
- Keywords
- stoma complications, SITI-CD Classification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University Third Hospital, Peking University First Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Beijing New Journey Cancer Hospital, Beijing Nanjiao Tumor Hospital, Xuanwu Hospital, Beijing, Beijing Hospital, Hebei medical college fourth hospital, China-Japan Union Hospital, Jilin University, Jiangsu Province people hospital, Jinzhou Medical University, Shanxi Province Cancer Hospital, Ruijin Hospital, Changhai Hospital, The Second Affiliated Hospital of Suzhou Medical University, Tianjin People's Hospital, Yantai Yuhuangding Hospital, First Affiliated Hospital of Zhejiang University, Zhejiang cancer University, China-Japan Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Affiliated Drum Tower Hospital, Nanjing University
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SITI-CD Classification of Stoma-related Complication in cancer patients | – | Diagnostic Test: Novel severity grading system of stoma-related complication in cancer patientsSITI-CD Classification of Stoma-related Complication in cancer patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with stoma after colorectal cancer resection.
Key exclusion criteria (1 listed)
- Patients who don't want to be studied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel severity grading system of stoma-related complication in cancer patientsOver 5000 stoma patients treated at 26 centers between 2022 and 2023 were classified according to SITI-CD Classification. | Diagnostic test | SITI-CD Classification of Stoma-related Complication in cancer patients |
Primary outcome
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.
2 secondary outcomes
Current status of surgeons' cognition of stoma complications
Time frame: 2022-08 till 2023-08
Global applicability of the SITI grades criteria
Time frame: 2022-08 till 2023-08
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided. Based on SITI classification, we will decide whether to conduct multicenter study or not
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LIN WANG principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication,Postoperative and Stoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIN WANG, MD (+8613910975011, wanglinmd@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stoma complications in different SITI grades (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.