Ventral Hernia Prevention After Liver Transplantation

Medical University of Graz

Status: Terminated

Conditions: Liver Transplantation; Ventral Hernia

Treatments: Device: Phasix mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03222102

Ventral hernia prevention

Details and patient eligibility

About

This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.

Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.

Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

Full description

Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.

This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.

PHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.

Patients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.

Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• First transplantation
• Signed Informed Consent

Exclusion criteria

• Combined transplantation
• Revisions after liver transplantation
• Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)
• Preexisting abdominal wall hernia except umbilical hernia after liver transplantation
• Pregnant/lactating women
• Known allergies to tetracycline hydrochloride and kanamycin sulfate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Phasix mesh

Experimental group

Description:

Phasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation.

Treatment:

Device: Phasix mesh

Standard surgery

No Intervention group

Description:

Surgery will be performed according to routine, without the use of Phasix mesh.