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

PHASE4RecruitingINTERVENTIONAL
Enrollment

966

Participants

Timeline

Start Date

September 8, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

August 31, 2027

Conditions
Rectal Cancer
Interventions
DEVICE

SIS-reinforced anastomosis

This intervention uses a porcine small intestinal submucosa (SIS) reinforcement patch during rectal anastomosis. The sterile, biologic, acellular mesh is mounted onto the stapler anvil and cartridge. When fired, it encircles and externally reinforces the staple line. This provides immediate mechanical support and promotes healing by serving as a scaffold for tissue integration. It is a single-use, resorbable material intended to reduce anastomotic leakage by improving seal integrity, distinguishing it from standard unreinforced stapling or other synthetic/biologic grafts.

Trial Locations (1)

100000

RECRUITING

Beijing chaoyang hospital, Beijing

All Listed Sponsors
collaborator

Beijing Hospital

OTHER_GOV

collaborator

Huashan Hospital

OTHER

collaborator

First Affiliated Hospital of Gannan Medical University

OTHER

collaborator

Guangdong Second Provincial General Hospital

OTHER

collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Changhai Hospital, Naval Medical University

UNKNOWN

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

Hubei Cancer Hospital

OTHER

collaborator

Hunan Provincial People's Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

Second Hospital of Jilin University

OTHER

collaborator

The Jiangxi Provincial People's Hospital

UNKNOWN

collaborator

The First Hospital of Lanzhou University, Gansu, China

UNKNOWN

collaborator

The First Affiliated Hospital of Nanchang University

OTHER

collaborator

Nanjing Jiangning Hospital

UNKNOWN

collaborator

The First Affiliated Hospital of BaoTou Medical College

OTHER

collaborator

The Affiliated Hospital of Qingdao University

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

NORTHERN JIANGSU PEOPLE'S HOSPITAL 1900

UNKNOWN

collaborator

Suzhou Municipal Hospital

OTHER

collaborator

Taizhou People's Hospital

UNKNOWN

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Zhongnan Hospital

OTHER

collaborator

The Third Xiangya Hospital of Central South University

OTHER

collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

collaborator

Yunnan Cancer Hospital

OTHER

collaborator

The First Affiliated Hospital, Zhejiang University

UNKNOWN

collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

PLA Rocket Force Characteristic Medical Center

OTHER

collaborator

The General Hospital of Western Theater Command

OTHER

collaborator

China-Japan Friendship Hospital

OTHER

collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

collaborator

The First Affiliated Hospital of Chongqing Medical University,China

UNKNOWN

collaborator

Zhoukou Central Hospital

OTHER

lead

Beijing Chao Yang Hospital

OTHER

NCT07209787 - SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak | Biotech Hunter | Biotech Hunter