Spots Global Cancer Trial Database for The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
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Trial Identification
Brief Title: The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
Official Title: The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
Study ID: NCT06204497
Conditions
Interventions
Study Description
Brief Summary: The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.
Detailed Description: In patients with rectal cancer who have a high risk of anastomotic leakage, we aim to compare the safety and effectiveness of SDT versus ileostomy in this study. The primary endpoint of the study was severe complications that occurred within 90 days of the surgery. The secondary endpoints included total complications, the incidence of coloanal anastomotic leakage (Grade B/C), postoperative hospital stay and cost, and postoperative quality of life evaluation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Friendship Hospital, Beijing, Beijing, China
Cancer Hospital, Peking University, Beijing, Beijing, China
Peking Union Hospital, Beijing, Beijing, China
Chinese PLA General Hospita, Beijing, Beijing, China
Fujian Union Hospital, Fujian Medical University, Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Union Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiangya Hospital, Central South Universit, Changsha, Hunan, China
The First Affiliated Hospital, Jilin University, Jilin, Jilin, China
Shengjing Hospital, China Medical University, Shenyang, Liaoning, China
The Affiliated Hospital, Qingdao University, Qingdao, Shandong, China
Cancer Hospital, Fudan University, Shanghai, Shanghai, China
ChangHai Hospital, The Second Military Medical University, Shanghai, Shanghai, China
Sichuan Cancer Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital, Ningbo University, Ningbo, Zhejiang, China
The Second Affiliated Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China
Contact Details
Name: XiuJun Cai, MD
Affiliation: Sir Run Run Shaw Hospital
Role: PRINCIPAL_INVESTIGATOR
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