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

2 november 2026 bijgewerkt door: Nanfang Hospital, Southern Medical University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

144

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Yanfeng Hu
  • Telefoonnummer: +86 13632494551
  • E-mail: yfenghu@qq.com

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Werving
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Medical Ethics committee of NanFang Hospital
          • Telefoonnummer: 020-62787238
          • E-mail: nfyyec@163.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental Group: Biological Mesh Reinforcement

Participants in this group will undergo alimentary tract reconstruction using a linear stapler with biological mesh reinforcement. During the procedure, researchers will record intraoperative raw data, including the number of bleeding points per unit length within 10 minutes after stapling, among other related clinical indicators. Following the surgery, participants will receive standard postoperative care. A 90-day monitoring period will be conducted to track anastomotic-related complications, specifically focusing on postoperative bleeding, leakage, stenosis, and other related conditions.
Apparaat: Biological Mesh for Digestive Surgery

A biological mesh specifically designed for reinforcement during alimentary tract reconstruction. It is used in conjunction with linear stapling devices during the surgical procedure to enhance the integrity of the anastomosis. The mesh provides mechanical support to the staple line, aiming to improve surgical outcomes by reducing intraoperative bleeding and the risk of postoperative complications, including leaks and stenosis, among other related conditions.
Actieve vergelijker: Control Group: Conventional Stapling

Participants in this group will undergo conventional alimentary tract reconstruction using a linear stapler alone. Identical intraoperative raw data regarding bleeding points and other related clinical indicators will be recorded for baseline comparison. Following the surgery, participants will receive standard postoperative care. Consistent with the experimental group, a 90-day monitoring period will track anastomotic-related complications, such as postoperative bleeding, leakage, stenosis, and other related conditions.
Procedure: Conventional Stapling

Participants will undergo conventional alimentary tract reconstruction using a linear stapler alone, without the use of reinforcing mesh.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of bleeding points per unit length
Tijdsspanne: Intraoperatively (within 10 minutes after stapling)

The number of bleeding points on the staple line or anastomosis that require clinical hemostasis or suture reinforcement within 10 minutes after stapler firing, divided by the total length of the line. Observation sites include: gastric resection margins, duodenal closure margins, intestinal closure margins, gastrointestinal anastomosis, esophagogastric anastomosis, esophagojejunal anastomosis, enteroenteric anastomosis, and others.
Intraoperatively (within 10 minutes after stapling)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of arterial pulsatile bleeding points per unit length
Tijdsspanne: Intraoperatively (within 10 minutes after stapling)

The number of arterial pulsatile bleeding points per unit length on the staple line or anastomosis requiring clinical hemostasis within 10 minutes after firing. Observation sites are consistent with the primary outcome.
Intraoperatively (within 10 minutes after stapling)
Time required for hemostatic management
Tijdsspanne: During the surgical procedure

The total duration (in minutes) spent on performing additional hemostasis or reinforcement procedures for bleeding points at the anastomosis or staple line.
During the surgical procedure
Total operative time
Tijdsspanne: From the start of surgery to the end of surgery

The total duration of the surgery.
From the start of surgery to the end of surgery
Incidence of anastomotic-related complications
Tijdsspanne: Up to 90 days post-surgery

The percentage of participants experiencing complications specifically related to the surgical connection, including anastomotic bleeding, anastomotic leakage, and anastomotic stenosis.
Up to 90 days post-surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nanfang Hospital, Southern Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 mei 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

2 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

6 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NFEC-2025-248

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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