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

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 m

Trial Details

NCT ID
NCT07209787
Phase
PHASE4
Sponsor
Beijing Chao Yang Hospital
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • SIS-reinforced anastomosis
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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 wit…
  • For patients who, after being fully informed by doctors, still clearly refuse neoadjuvant therapy (for advanced rectal cancer) and/or immunotherapy…
  • Patients who received conversion therapy due to distant organ (such as liver, lung) metastasis before surgery and then underwent surgery with prima…

For full eligibility, visit ClinicalTrials.gov.

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