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.
Age ≤ 85 years old, regardless of gender.
Patients with mid - low rectal cancer, where the lower edge of the cancer focus is ≤ 10 cm from the anus and who can undergo rectal anastomosis with a circular stapler (including mid - low and some ultra - low rectal anastomoses). This includes patients after neoadjuvant therapy, patients with insufficient function of important organs such as the heart, liver, and kidneys who can tolerate surgery, and patients after intestinal obstruction stent placement or chemotherapy after intestinal obstruction stent placement.
For patients who, after being fully informed by doctors, still clearly refuse neoadjuvant therapy (for advanced rectal cancer) and/or immunotherapy (for MSI - H/dMMR rectal cancer) and request direct surgery, they are generally not included in this study. If a patient insists on enrolling, the operating surgeon must have a second conversation with the patient and/or their family members, and sign in the medical record to confirm the following: The patient is aware of the existence of the neoadjuvant therapy/immunotherapy pathway but refuses the relevant treatment and insists on direct surgery. Only in this case can the patient be allowed to enroll.
Patients who received conversion therapy due to distant organ (such as liver, lung) metastasis before surgery and then underwent surgery with primary anastomosis can be included in this study. If organ metastasis is accidentally found during surgery, or if the small intestine or bladder in the pelvic floor is invaded, but the surgeon believes it does not affect rectal anastomosis, the patient does not need to withdraw from the study.
Patients who, through examination and pre - operative consultation, cannot tolerate routine surgery.
Patients who are currently participating in other clinical studies.
Since the test device (SIS reinforcement patch) is derived from porcine - sourced materials, out of respect for specific religious beliefs (such as Islam), we do not recommend that subjects whose beliefs prohibit contact with porcine - sourced products participate in this study. We will fully communicate this situation with all potential subjects, and the subjects will make their own decisions based on their personal beliefs and cultural backgrounds.
Patients who do not meet the NCCN and the National Health Commission of China's treatment standards for rectal cancer will not be included in this study. For example, patients who should receive neoadjuvant therapy before surgery should preferentially choose neoadjuvant therapy, and MSI - H/dMMR patients are required to undergo immunotherapy first.
Parallel
SIS-reinforced anastomosis
DeviceThis 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.
Rate of anastomotic leak within 30 days post-surgery
Proportion of participants with an anastomotic leak (AL) within 30 days post-surgery. AL is a defect in the intestinal wall anastomosis, confirmed by clinical signs (e.g., fever, fecal drain output), imaging (CT scan with contrast extravasation or peri-anastomotic collections), or endoscopy. Leaks are graded per International Study Group of Rectal Cancer (ISREC) criteria: Grade A (no intervention), B (managed without reoperation), or C (requires reoperation).
Rate of anastomotic leak within 30 days post-surgery
The proportion of participants experiencing an anastomotic leak (AL) within 30 days after surgery. AL is defined as a defect in the integrity of the intestinal wall at the anastomosis site, leading to communication between the intra- and extraluminal compartments. Diagnosis is based on a combination of clinical signs (e.g., fever, abdominal pain, fecal discharge from drain), imaging findings (extravasation of contrast on enema CT scan or presence of peri-anastomotic fluid/air collections), or endoscopic evidence. Leaks are graded per the International Study Group of Rectal Cancer (ISREC) classification: Grade A (requiring no active therapeutic intervention), Grade B (requiring active therapeutic intervention but manageable without reoperation), and Grade C (requiring reoperation).
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Beijing Chao Yang Hospital
Lead sponsor
Beijing Hospital
Collaborator
Huashan Hospital
Collaborator
First Affiliated Hospital of Gannan Medical University
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Changhai Hospital, Naval Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
Hubei Cancer Hospital
Collaborator
Hunan Provincial People's Hospital
Collaborator
Tongji Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Second Hospital of Jilin University
Collaborator
Jiangxi Provincial People's Hopital
Collaborator
The First Hospital of Lanzhou University, Gansu, China
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Nanjing Jiangning Hospital
Collaborator
The First Affiliated Hospital of BaoTou Medical College
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Qilu Hospital of Shandong University
Collaborator
NORTHERN JIANGSU PEOPLE'S HOSPITAL 1900
Collaborator
Suzhou Municipal Hospital
Collaborator
Jiangsu Taizhou People's Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Zhongnan Hospital
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Yunnan Cancer Hospital
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
PLA Rocket Force Characteristic Medical Center
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The General Hospital of Western Theater Command
Collaborator
China-Japan Friendship Hospital
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Zhoukou Central Hospital
Collaborator
