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

Summary

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.

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.

Sponsors & Collaborators

• Beijing Hospital

  collaborator OTHER_GOV

• Huashan Hospital

  collaborator OTHER

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Changhai Hospital, Naval Medical University

  collaborator UNKNOWN

• Henan Provincial People's Hospital

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

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

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• The Jiangxi Provincial People's Hospital

  collaborator UNKNOWN

• The First Hospital of Lanzhou University, Gansu, China

  collaborator UNKNOWN

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Nanjing Jiangning Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of BaoTou Medical College

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• NORTHERN JIANGSU PEOPLE'S HOSPITAL 1900

  collaborator UNKNOWN

• Suzhou Municipal Hospital

  collaborator OTHER

• Taizhou People's Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• The First Affiliated Hospital, Zhejiang University

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• PLA Rocket Force Characteristic Medical Center

  collaborator OTHER

• The General Hospital of Western Theater Command

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Zhoukou Central Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-11

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• China

Study Locations