Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: inguinal hernia repair with mesh

• Registration Number: NCT05706662
• Lead Sponsor: University of Palermo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Last Update Submitted: 2023-01-21
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 hernia
• Incarcerated inguinal hernia
• Hernia not in the inguinal area
• Signs of obvious local or systemic infection
• ASA score > 4
• Presenting with unstable angina or NYHA class of IV
• Pregnant
• Active drug user
• Immunosuppression, chemotherapy
• Chronic renal insufficiency
• Abdominal ascites
• Infection in area of the surgical field
• BMI >35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lichtenstein	inguinal hernia repair with mesh	patients underwent to Lichtenstein inguinal hernia repair
ProFlor	inguinal hernia repair with mesh	patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold

Primary Outcome Measures

Name	Time	Method
early postoperative complications	30 days after surgery	bleeding, hematoma and infections
patients clinical outcome	24 months	VAS score

Secondary Outcome Measures

Name	Time	Method
evaluation of quality of life during the postoperative period	24 months	Carolina Comfort Scale - CCS

Trial Locations

Locations (1)

University of Palermo; 🇮🇹 Palermo, Italy