RecruitingNot ApplicableNCT05306496

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up

Sponsor

Cousin Biotech

Enrollment

200 participants

Start Date

Aug 4, 2022

Study Type

INTERVENTIONAL

Conditions

Inguinal Hernia Femoral Hernia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
Patients with American Society of Anesthesiologists (ASA) grade I to III.
Patient ≥ 18 years of age at study entry.
Patient and investigator signed and dated the informed consent form prior to the index-procedure.

Exclusion Criteria12

Patient has a recurrent inguinal or femoral hernia.
Patient is treated using the Lichtenstein technique.
Patients with ASA grade IV and V.
Patient is allergic to the components of the 4DMESH®.
Presence of an infected site.
Patient has a life expectancy of less than 5 years.
Patient is unable / unwilling to provide informed consent.
Patient is unable to comply with the protocol or proposed follow-up visits.
Patient is enrolled in another study (BE/ES) / Participation in a clinical trial within 3 months prior to the initial visit (FR).
Patient is pregnant (BE/FR) / Pregnant women (ES).
Patient benefiting from a legal protection measure (minors, under guardianship, curatorship, safeguard of justice, future protection mandate or family empowerment) (FR).
Patient not benefiting from a social protection scheme (FR).

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Interventions

DEVICEPre-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.