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OpenTrials
Completed

NCT Number: NCT04718298

Laparoscopic Hernia Defect Obliteration With ProFlor-E

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

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo

Palermo, Please Select, 90100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ASA >4 patients

Treatment and study plan

ProFlor laparoscopic technique

Device

Inguinal hernia repair laparoscopic

Primary outcomes

  1. Feasibility of inguinal hernia defect obliteration with ProFlor

    Time frame: intraoperative

    Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor

Secondary outcomes

  1. Postoperative pain

    Time frame: from early stage until 18 months postop

    assessment of postoperative pain through Visual Analogue Scale

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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