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Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
Sponsor: Cousin Biotech
Summary
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
Official title: Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-08-04
Completion Date
2029-09-30
Last Updated
2024-04-16
Healthy Volunteers
No
Conditions
Interventions
Pre-shaped 4DMESH®
The 4DMESH® mesh is semi-resorbable parietal reinforcement implant made of 25% Polypropylene (non-resorbable) and 75% Poly-L-Lactic Acid (resorbable). 4DMESH® meshes are designed for the repair and reinforcement of inguinal and femoral hernias. 4DMesh is a CE-marked, class III medical device manufactured by Cousin Biotech.
Locations (9)
Ziekenhuis Oost-Limburg Genk
Genk, Limburg, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Vlaams-Brabant, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium
Hôpital Lyon Sud, Hospices Civils de Lyon
Lyon, France
CHU de Nantes
Nantes, France
CHU de Reims
Reims, France
CH de Tourcoing
Tourcoing, France
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Viamed Santa Ángela de la Cruz en Sevilla
Seville, Spain