Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. | Clinical Trial | StuddyBuddy@endsection Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.
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Completed NCT05706662

Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

Conditions: Inguinal Hernia

Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 188
Sponsor: University of Palermo

Location: Italy

Summary

Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.

Eligibility Criteria

Inclusion Criteria:Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia.Exclusion Criteria:Recurrent inguinal herniaIncarcerated inguinal herniaHernia not in the inguinal areaSigns of obvious local or systemic infectionASA score > 4Presenting with unstable angina or NYHA class of IVPregnantActive drug userImmunosuppression, chemotherapyChronic renal insufficiencyAbdominal ascitesInfection in area of the surgical fieldBMI >35

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05706662). StuddyBuddy aggregates publicly available trial information.