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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia; Femoral Hernia
• Intervention / Treatment: Device: Pre-shaped 4DMESH®

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg Genk
  • Vlaams-Brabant
    • Tienen, Vlaams-Brabant, Belgium, 3300
      • Regionaal Ziekenhuis Heilig Hart Tienen
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • AZ Groeninge
• France
  • Lyon, France, 69002
    • Hôpital Lyon Sud, Hospices Civils de Lyon
  • Nantes, France, 44093
    • CHU de Nantes
  • Reims, France, 51092
    • CHU de Reims
  • Tourcoing, France, 59208
    • CH de Tourcoing
• Spain
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41014
    • Hospital Viamed Santa Ángela de la Cruz en Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.	At 12-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	To determine the percentage of procedures with technical success, defined as (robot-assisted) laparoscopic TEP or TAPP as intended without technical difficulties and without conversion to open laparotomy.	At index-procedure
Duration of surgery	To determine the mean duration of the surgery.	At index-procedure
Duration of hospital stay	To determine the mean duration of hospital stay.	At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
Peri- and post-operative complications related to 4DMESH®	To determine the rate of peri- and post-operative complications related to 4DMESH® up to 5-years follow-up.	At 5-years follow-up
Early recurrences	To determine the early recurrence rate at 4-5 weeks follow-up.	At 4-5 weeks follow-up
Late recurrence rate	To determine the recurrence rate at 24-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).	At 24-months follow-up
Late recurrence rate	To determine the recurrence rate at 60-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).	At 60-months follow-up
Mesh migration and mesh shrinkage	To evaluate the incidence of mesh migration and mesh shrinkage at 12-months follow-up via abdominal ultrasound (only in specialized investigational centers ).	At 12-months follow-up
Re-intervention	To determine the incidence of hernia surgery related re-interventions since the (robot-assisted) laparoscopic TEP or TAPP procedure.	At 5-years follow-up
Explantation rate	To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.	At 5-years follow-up
Return to daily activities	To determine the mean number of days when the patient returned to daily activities after the operation, assessed at 4-5 weeks follow-up.	At 4-5 weeks follow-up
Return to work	To determine the mean number of days when the patient returned to work after the operation, assessed at 4-5 weeks follow-up.	At 4-5 weeks follow-up
Pre-operative pain scoring	To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).	At baseline
Post-operative pain scoring	To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).	At discharge, an average of 1 day
Post-operative pain scoring	To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).	At 4-5 weeks follow-up
Post-operative pain scoring	To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).	At 12-months follow-up
Post-operative pain scoring	To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).	At 24-months follow-up
Post-operative pain scoring	To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain).	At 60-months follow-up
Intake of analgesics	To register intake of analgesics.	At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
Intake of analgesics	To register intake of analgesics.	At 4-5 weeks follow-up
Intake of analgesics	To register intake of analgesics.	At 12-months follow-up
Intake of analgesics	To register intake of analgesics.	At 24-months follow-up
Intake of analgesics	To register intake of analgesics.	At 60-months follow-up
QoL	To assess QoL by the EQ-5D questionnaire.	At baseline
QoL	To assess QoL by the EQ-5D questionnaire.	At 4-5 weeks follow-up
QoL	To assess QoL by the EQ-5D questionnaire.	At 12-months follow-up
QoL	To assess QoL by the EQ-5D questionnaire.	At 24-months follow-up
QoL	To assess QoL by the EQ-5D questionnaire.	At 60-months follow-up
EQ-5D change	To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).	At 4-5 weeks follow-up
EQ-5D change	To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).	At 12-months follow-up
EQ-5D change	To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).	At 24-months follow-up
EQ-5D change	To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).	At 60-months follow-up
Subjective groin symptoms	To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).	At 4-5 weeks follow-up
Subjective groin symptoms	To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).	At 12-months follow-up
Subjective groin symptoms	To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).	At 24-months follow-up
Subjective groin symptoms	To assess subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin).	At 60-months follow-up
Global groin symptoms	To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).	At 4-5 weeks follow-up
Global groin symptoms	To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).	At 12-months follow-up
Global groin symptoms	To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).	At 24-months follow-up
Global groin symptoms	To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).	At 60-months follow-up
Impact on sex life	To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).	At 4-5 weeks follow-up
Impact on sex life	To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).	At 12-months follow-up
Impact on sex life	To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).	At 24-months follow-up
Impact on sex life	To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).	At 60-months follow-up

Collaborators and Investigators

• Sponsor: Cousin Biotech

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): September 23, 2025
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal; Hernia, Femoral
• Other Study ID Numbers: RAPID4D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No