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

2. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

144

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Fremgangsmåte: Conventional Stapling

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nanfang Hospital, Southern Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. mai 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NFEC-2025-248

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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