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临床试验/NCT07111429
NCT07111429尚未招募不适用

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

Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,000
试验地点
1
主要终点
Incidence of stoma complications in different SITI grades

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stoma after colorectal cancer resection.

排除标准

  • Patients who don't want to be studied

结局指标

主要结局

Incidence of stoma complications in different SITI grades

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Peking University Cancer Hospital & Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaokang Lei

Professor of Surgery, Chief physician, MD

Peking University Cancer Hospital & Institute

研究点 (1)

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