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

2. november 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

144

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Yanfeng Hu
  • Telefonnummer: +86 13632494551
  • E-mail: yfenghu@qq.com

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Nanfang Hospital, Southern Medical University
        • Kontakt:
          • Medical Ethics committee of NanFang Hospital
          • Telefonnummer: 020-62787238
          • E-mail: nfyyec@163.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of bleeding points per unit length
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of arterial pulsatile bleeding points per unit length
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanfang Hospital, Southern Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. maj 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

2. november 2026

Først indsendt, der opfyldte QC-kriterier

2. november 2026

Først opslået (Faktiske)

6. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NFEC-2025-248

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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