Laparoscopic hernia repair using a special mesh

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

This study tests whether a special type of mesh used in laparoscopic hernia repairs can help patients recover better and have fewer problems after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cousin Biotech (Industry-sponsored)
• Locations: 9 sites (Genk, Limburg and 8 other locations)
• Trial ID: NCT05306496 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the pre-shaped 4DMESH® in laparoscopic repairs of inguinal and femoral hernias. It aims to assess outcomes such as recurrence rates, pain levels, quality of life, and complications through a prospectively maintained database. Patients undergoing this procedure will be monitored for their recovery and return to daily activities.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with primary unilateral or bilateral inguinal or femoral hernias eligible for laparoscopic repair.

Not a fit: Patients with recurrent hernias or those who are not suitable for laparoscopic techniques will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for patients with inguinal and femoral hernias.

How similar studies have performed: Other studies using similar laparoscopic techniques have shown promising results, suggesting that this approach may be effective.

Eligibility criteria

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).

Where this trial is running

Genk, Limburg and 8 other locations

• Ziekenhuis Oost-Limburg Genk — Genk, Limburg, Belgium (Active_not_recruiting)
• Regionaal Ziekenhuis Heilig Hart Tienen — Tienen, Vlaams-Brabant, Belgium (Recruiting)
• AZ Groeninge — Kortrijk, West-Vlaanderen, Belgium (Recruiting)
• Hôpital Lyon Sud, Hospices Civils de Lyon — Lyon, France (Active_not_recruiting)
• CHU de Nantes — Nantes, France (Active_not_recruiting)
• CHU de Reims — Reims cedex, France (Active_not_recruiting)
• CH de Tourcoing — Tourcoing, France (Active_not_recruiting)
• Hospital Universitario Virgen Macarena — Sevilla, Spain (Active_not_recruiting)
• Hospital Viamed Santa Ángela de la Cruz en Sevilla — Sevilla, Spain (Active_not_recruiting)

Study contacts

• Study coordinator: Dorien Haesen, PhD

Conditions Inguinal Hernia; Femoral Hernia