SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak

The goal of this clinical trial is to learn whether using a reinforcing material called SIS (small intestinal submucosa) during bowel connection after rectal cancer surgery can help prevent anastomotic leakage-a serious complication where the connection between two parts of the intestine fails to heal properly. This study will focus on patients with mid-to-low rectal cancer who are scheduled for surgery. The main questions the study aims to answer are: Does using an SIS-reinforced connection reduce the rate of anastomotic leakage within 30 days after surgery compared to standard connection methods? Does it also reduce the need for a temporary stoma (an opening in the abdomen for waste removal)? Researchers will compare two groups: Intervention group: Patients who receive the SIS-reinforced connection during surgery. Control group: Patients who receive the standard connection without reinforcement. Participants in this study will: Be randomly assigned to either the intervention or control group. Undergo standard laparoscopic or robot-assisted rectal cancer surgery. Be followed up at 30 days, 90 days, and 12 months after surgery to check for complications, stoma status, and quality of life. This study is being conducted across multiple hospitals in China to ensure the results are reliable and widely applicable.

NCT Number	NCT07209787
Lead Sponsor	Beijing Chao Yang Hospital Collaborators: Beijing Hospital, Huashan Hospital, First Affiliated Hospital of Gannan Medical University, Guangdong Second Provincial General Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Harbin Medical University, Changhai Hospital, Henan Provincial People's Hospital, Hubei Cancer Hospital, Hunan Provincial People's Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Hospital of Jilin University, Jiangxi Provincial People's Hopital, LanZhou University, The First Affiliated Hospital of Nanchang University, Nanjing Jiangning Hospital, The First Affiliated Hospital of BaoTou Medical College, The Affiliated Hospital of Qingdao University, Qilu Hospital of Shandong University, NORTHERN JIANGSU PEOPLE'S HOSPITAL 1900, Suzhou Municipal Hospital, Jiangsu Taizhou People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhongnan Hospital, The Third Xiangya Hospital of Central South University, First Affiliated Hospital of Xinjiang Medical University, Yunnan Cancer Hospital, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Zhengzhou University, PLA Rocket Force Characteristic Medical Center, The General Hospital of Western Theater Command, China-Japan Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chongqing Medical University, Zhoukou Central Hospital
Conditions	Rectal Cancer
Enrollment	966 participants
Start Date	2025-10-21
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-17