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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2029-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia Femoral Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No