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Enrolling By Invitation
NCT07744230
Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study.
Conditions: Incisional Hernia/Prevention and Control
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: University of Rome Tor Vergata
Location: Policlinico Tor Vergata Rome Lazio
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 Criteria
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 \ 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 \ 2cm in diameter, pre-Tx steroids treatment or immunosuppression, patient's rejection to participate.
Source: ClinicalTrials.gov (NCT07744230). StuddyBuddy aggregates publicly available trial information.