Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06204497
NA

The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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