Laparoscopic Hernia Defect Obliteration With ProFlor-E

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: ProFlor laparoscopic technique

• Registration Number: NCT04718298
• Lead Sponsor: University of Cagliari

Brief Summary

This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect

Detailed Description

The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias

Exclusion Criteria

• ASA >4 patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Inguinal hernia repair laparoscopic	ProFlor laparoscopic technique	recurrent inguinal hernia after open repair or bilateral hernia patients

Primary Outcome Measures

Name	Time	Method
Feasibility of inguinal hernia defect obliteration with ProFlor	intraoperative	Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	from early stage until 18 months postop	assessment of postoperative pain through Visual Analogue Scale

Trial Locations

Locations (1)

University of Palermo; 🇮🇹 Palermo, Please Select, Italy