NCT07111429

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 1, 2025

Last Update Submit

August 1, 2025

Conditions

Complication,PostoperativeStoma

Keywords

stoma complicationsSITI-CD Classification

Outcome Measures

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.

    1year

Secondary Outcomes (2)

  • Current status of surgeons' cognition of stoma complications

    2022-08 till 2023-08

  • Global applicability of the SITI grades criteria

    2022-08 till 2023-08

Study Arms (1)

SITI-CD Classification of Stoma-related Complication in cancer patients

SITI-CD Classification of Stoma-related Complication in cancer patients

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

Interventions

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.

SITI-CD Classification of Stoma-related Complication in cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with stoma after colorectal cancer resection.

You may not qualify if:

  • Patients who don't want to be studied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • LIN WANG

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LIN WANG, MD

CONTACT

+8613910975011wanglinmd@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Chief physician, MD

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

August 15, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations

CN(1)