SIS-reinforced versus standard bowel connection after mid-to-low rectal cancer surgery

A Prospective, Multicenter, Randomized Controlled Study Comparing Effect of Conventional Versus SIS-Reinforced Rectum Anastomosis On Anastomotic Leak Following Radical Resection of Mid-to-Low Rectal Cancer（SISReal）

This trial will test whether using an SIS patch at the bowel connection lowers leak rates and the need for a temporary stoma in people having mid-to-low rectal cancer surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 966 (estimated)
• Ages: N/A to 85 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07209787 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter Phase 4 trial compares SIS (small intestinal submucosa) reinforcement placed around a stapled colorectal anastomosis with the conventional stapled anastomosis in patients with mid-to-low rectal cancer. Patients are randomly assigned to receive either the SIS-reinforced anastomosis or the standard anastomosis, and outcomes are tracked after surgery. The primary outcome is anastomotic leakage within 30 days, and secondary outcomes include rates of temporary stoma formation and postoperative complications. The trial is being run at major Chinese tertiary hospitals with standardized surgical protocols and follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults up to 85 years old with mid-to-low rectal cancer (tumor edge ≤10 cm from the anus) who are planned for a circular-stapled rectal anastomosis and can tolerate surgery.

Not a fit: Patients with high rectal tumors not suitable for a stapled anastomosis, those unfit for surgery, or those requiring a different surgical approach are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, SIS reinforcement could reduce anastomotic leaks and lower the need for temporary stomas after rectal cancer surgery.

How similar studies have performed: Small series and retrospective reports have suggested that reinforcement materials may reduce leak rates, but large randomized evidence specifically for SIS reinforcement is limited.

Eligibility criteria

Inclusion Criteria--

1. Age ≤ 85 years old, regardless of gender.
2. 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.
3. 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.
4. 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.
5. The patient or their authorized representative voluntarily signs the informed consent form and can cooperate to complete the follow - up during the trial.

Exclusion Criteria--

1. Patients who, through examination and pre - operative consultation, cannot tolerate routine surgery.
2. Patients who are currently participating in other clinical studies.
3. 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.
4. 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.
5. Due to the possible difficulty in matching the number of patients/omissions with regular patients, patients who require lateral lymph node dissection and those who receive Ta - TME will not be included in this study.
6. Patients who, due to language or intellectual disabilities, cannot understand the content of the trial protocol, cannot complete the follow - up, or for whom the researcher deems there are other situations that are not suitable for enrollment (such as uncontrolled severe underlying diseases, mental illness, etc.).

Where this trial is running

Beijing, Beijing Municipality

• Beijing chaoyang hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chunxiang Ye

Conditions Rectal Cancer