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Clinical Trials in Italy / NCT07744230
Enrolling by invitation Observational

Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study.

NCT07744230 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-05-15
Last updated
2026-08-04

Condition(s) studied

Incisional Hernia/Prevention and Control

Investigational drug(s) / intervention(s)

mesh

mesh: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: \- 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Policlinico Tor Vergata Rome Lazio

More University of Rome Tor Vergata trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07744230 on ClinicalTrials.gov ↗ ← All trials in Italy