Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanfeng Hu
- Número de teléfono: +86 13632494551
- Correo electrónico: yfenghu@qq.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510515
- Reclutamiento
- Nanfang Hospital, Southern Medical University
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Contacto:
- Medical Ethics committee of NanFang Hospital
- Número de teléfono: 020-62787238
- Correo electrónico: nfyyec@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Aged 18 to 75 years (inclusive).
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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American Society of Anesthesiologists (ASA) physical status classification of Grade I, II, or III.
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Scheduled for laparoscopic or open surgery involving gastrointestinal-related anastomosis.
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Participants must meet the following laboratory criteria:
- Hemoglobin (Hb) ≥ 90 g/L;
- White Blood Cell (WBC) count ≥ 3 × 10^9/L and ≤ 12 × 10^9/L;
- Platelet (PLT) count ≥ 100 × 10^9/L;
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2 × Upper Limit of Normal (ULN);
- Total Bilirubin (T-Bil) ≤ 1.5 × ULN;
- Serum Creatinine (Cr) ≤ 1 × ULN;
- Serum Albumin ≥ 30 g/L.
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Able to understand and sign the informed consent form.
Exclusion Criteria:
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test.
- Patients with coagulation disorders.
- Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, or uncontrolled chronic systemic diseases such as diabetes or hypertension.
- 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.
- Presence of severe uncontrolled recurrent infections.
- Known allergy or hypersensitivity to collagen or bovine-derived materials.
- Current participation in other clinical trials for drugs or medical devices that have not yet reached the primary endpoint time point.
- Any other medical condition (including follow-up and compliance issues) that, in the investigator's opinion, may or will interfere with the study process.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
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. |
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Comparador activo: 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. |
Participants will undergo conventional alimentary tract reconstruction using a linear stapler alone, without the use of reinforcing mesh. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of bleeding points per unit length
Periodo de tiempo: Intraoperatively (within 10 minutes after stapling)
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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)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of arterial pulsatile bleeding points per unit length
Periodo de tiempo: Intraoperatively (within 10 minutes after stapling)
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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)
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Time required for hemostatic management
Periodo de tiempo: During the surgical procedure
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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
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Total operative time
Periodo de tiempo: From the start of surgery to the end of surgery
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The total duration of the surgery. |
From the start of surgery to the end of surgery
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Incidence of anastomotic-related complications
Periodo de tiempo: Up to 90 days post-surgery
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NFEC-2025-248
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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