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The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
Sponsor: Sir Run Run Shaw Hospital
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.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
570
Start Date
2024-01-31
Completion Date
2025-09-28
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
Stent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.
Locations (20)
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
Peking Union Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospita
Beijing, Beijing Municipality, 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 Municipality, China
ChangHai Hospital, The Second Military Medical University
Shanghai, Shanghai Municipality, 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