Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study.

Enrolling by invitation

Conditions studied: Incisional Hernia/Prevention and Control

In brief

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.

Key facts

Study ID

NCT07744230

Run by

University of Rome Tor Vergata

People needed

100

Starts

2025-05-15

Expected to finish

2029-05-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Policlinico Tor Vergata — Rome, Lazio, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.