Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study.

NCT07744230 | Enrolling By Invitation

• 1 other identifier: REGISTRO SPERIMENTAZIONI 284.2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter prospective, consecutive case series study, on the use of a bio-absorbable mesh for prevention of incisional hernia, in high risk patients, after orthotopic liver transplantation.

Conditions

Incisional Hernia/Prevention and Control

Keywords

liver transplantation; incisional hernia; prevention; mesh

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernias after LT

  To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.

  2 years follow up

Secondary Outcomes (1)

• Incidence of IH in different type of incisions, Incidence od SSO

  2 years follow up

Interventions

mesh PROCEDURE

The technique used for surgical incision and for abdominal wall closure will follow each participating center policy. A slowly absorbable material will be used for closure by all centers. After conventional closure a bio-absorbable mesh will be placed in a onlay position (PHASIX - C. R. Bard, Inc/Davol Inc, Warwick, RI). The above mentioned meshes are currently available in the participating centers. The surgeons will be specifically trained in using a prophylactic onlay mesh. An overlapping of 3 cm must be obtained on every side of surgical incision. Fixation methods allowed: interrupted long- term absorbable suture. Subcutaneous and skin closure following center practice. The operating surgeon can decide for the placement of a subcutaneous drain if necessary.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing liver transplantation in 5 centers in Italy

You may qualify if:

• Have at least 3 of the following pre transplant risk factors for IH (definition of high Risk Patients):
• Age \>60
• Sex M
• Obesity (HR 1.74, 1.04 to 2.91) (16) (BMI equal to or higher than 30 kg/m², according WHO definition)
• Smoker (OR 3.93, 1.82 to 8.49) (14). An adult who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day, according WHO definition.
• Diabetes (OR 6.68, 2.02 to 22.0) (14) as defined by Centers of Disease Control and Prevention):
• Result A1C Test Fasting Blood Sugar Test Glucose Tolerance Test Random Blood Sugar Test Diabetes 6.5% or above 126 mg/dL or above 200 mg/dL or above 200 mg/dL or above
• IRC according KDIGO definition: "CKD is defined as abnormalities of kidney structure or function, present for \>3 months, with implications for health," and requires one of two criteria documented or inferred for \>3 months: either GFR \<60 ml/min/1.73 m2 or markers of kidney damage, including albuminuria.
• MELD \> 22 (16)
• COPD (HR 2.35, 1.44 to 3.83) (16): previous diagnosis of emphysema, chronic bronchitis, and chronic obstructive asthma. In pulmonary function testing, a postbronchodilator FEV1/FVC ratio of \<0.70 is commonly considered diagnostic for COPD according The Global Initiative for Chronic Obstructive Lung Disease (GOLD) system.
• Moderate/Large ascites at time of transplant. The International Ascites Club classifies the severity classification of ascites as follows: moderate ascites (grade 2): moderate abdominal distention, large ascites (grade 3): marked abdominal distention.
• Sarcopenia (if diagnosed with CT-scan or RM). The study of the muscular compartment at the level of the third lumbar vertebra (L3) by CT is the gold standard technique in the assessment of sarcopenia. (10) The sum of the areas of psoas, erector spinae, multifidus, quadratus lomborum, rectus of the abdomen, transverse and internal and external obliques are divided by the squared height of the patient and define the skeletal muscle index: SMI (Skeletal Muscle Index) = SMA (Skeletal Muscle Area) (cm²) / height (m²). Sarcopenia is defined by cut-off values below 41,6 cm²/m² for men and 32 cm²/m² for women.

You may not qualify if:

• \- retransplant, previous upper quadrants laparotomies, previous incisional hernia repair, umbilical hernia \> 2cm in diameter, pre-Tx steroids treatment or immunosuppression, patient's rejection to participate.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

MeSH Terms

Conditions

Incisional Hernia

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)