Biological mesh reinforcement for digestive tract reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter Phase III randomized trial comparing biological mesh reinforcement with standard stapling in digestive surgery. It aims to see if the mesh lowers bleeding at the anastomosis and reduces postoperative issues like leaks or narrowing within 90 days. Participants will be adults 18–75 planned for GI tract anastomosis, assigned to either the mesh or conventional approach. Outcomes will include safety and efficacy of the reconstruction technique in real-world surgical settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yanfeng Hu
• Email: yfenghu@qq.com
• Phone: +86 13632494551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.