Actively Recruiting
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak
Led by Beijing Chao Yang Hospital · Updated on 2026-03-13
966
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
B
Beijing Chao Yang Hospital
Lead Sponsor
B
Beijing Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 85 years or younger, any gender
- Diagnosis of mid-to-low rectal cancer with tumor located 10 cm or less from the anus
- Eligible for rectal anastomosis using a circular stapler, including patients after neoadjuvant therapy or with some organ dysfunction who can tolerate surgery
- Patients who refuse neoadjuvant or immunotherapy after being informed and consent to direct surgery with surgeon confirmation
- Patients who had conversion therapy for distant metastasis and then surgery with primary anastomosis
- Voluntary informed consent and ability to complete follow-up during the trial
You will not qualify if you...
- Unable to tolerate routine surgery based on examination and consultation
- Currently participating in other clinical studies
- Religious beliefs prohibiting contact with porcine-derived products like the SIS reinforcement patch
- Not meeting treatment standards for rectal cancer, such as needing neoadjuvant therapy or immunotherapy first
- Patients requiring lateral lymph node dissection or who receive Ta-TME surgery
- Inability to understand the trial protocol or complete follow-up due to language, intellectual disabilities, severe uncontrolled diseases, or mental illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing chaoyang hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
C
Chunxiang Ye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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