NCT07921732 Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery

Eligibility & Interventions

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This trial targets 144 participants in total. It began in 2026-05-06 with a primary completion date of 2027-12-31.

Brief Summary

The goal of the Phase III clinical trial is to evaluate whether using a biological mesh helps improve the efficacy and safety of alimentary tract reconstruction surgery. In digestive surgery, bleeding or leakage at the surgical connection (anastomosis) remains a significant clinical challenge. This study explores whether reinforcing the anastomosis with a biological mesh can effectively reduce these risks and significantly enhance the reliability of the surgical procedure. The main objectives of this study are: To evaluate the effectiveness of the biological mesh in reducing bleeding points at the surgical site during the procedure. To assess the role of the mesh in lowering the risk of postoperative complications, such as anastomotic leaks or stenosis, within 90 days after surgery. Study Groups: Experimental Group: Participants who undergo alimentary tract reconstruction with biological mesh reinforcement during surgery. Control Group: Participants who undergo conventional surgical procedures without the use of mesh. Participant Flow: Participants will undergo a health evaluation before surgery to confirm they meet the study criteria. Following the procedure, participants will receive standard postoperative care and return for follow-up clinic visits 30 and 90 days after surgery to monitor their recovery.

Eligibility Criteria

Inclusion Criteria: 1. Aged 18 to 75 years (inclusive). 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 3. American Society of Anesthesiologists (ASA) physical status classification of Grade I, II, or III. 4. Scheduled for laparoscopic or open surgery involving gastrointestinal-related anastomosis. 5. Participants must meet the following laboratory criteria: 1. Hemoglobin (Hb) ≥ 90 g/L; 2. White Blood Cell (WBC) count ≥ 3 × 10\^9/L and ≤ 12 × 10\^9/L; 3. Platelet (PLT) count ≥ 100 × 10\^9/L; 4. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2 × Upper Limit of Normal (ULN); 5. Total Bilirubin (T-Bil) ≤ 1.5 × ULN; 6. Serum Creatinine (Cr) ≤ 1 × ULN; 7. Serum Albumin ≥ 30 g/L. 6. Able to understand and sign the informed consent form. Exclusion Criteria: 1. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test. 2. Patients with coagulation disorders. 3. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, or uncontrolled chronic systemic diseases such as diabetes or hypertension. 4. Clinically significant cardiac diseases, including congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias or hypertension poorly controlled by medication, myocardial infarction within the past 6 months, or cardiac insufficiency. 5. Presence of severe uncontrolled recurrent infections. 6. Known allergy or hypersensitivity to collagen or bovine-derived materials. 7. Current participation in other clinical trials for drugs or medical devices that have not yet reached the primary endpoint time point. 8. Any other medical condition (including follow-up and compliance issues) that, in the investigator's opinion, may or will interfere with the study process.

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