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

April 14, 2026 updated by: Cousin Biotech

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hernia recurrence
Time Frame: At 12-months follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: At index-procedure
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
Time Frame: At index-procedure
To determine the mean duration of the surgery.
At index-procedure
Duration of hospital stay
Time Frame: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
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®
Time Frame: At 5-years follow-up
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
Time Frame: At 4-5 weeks follow-up
To determine the early recurrence rate at 4-5 weeks follow-up.
At 4-5 weeks follow-up
Late recurrence rate
Time Frame: At 24-months follow-up
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
Time Frame: At 60-months follow-up
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
Time Frame: At 12-months follow-up
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
Time Frame: At 5-years follow-up
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
Time Frame: At 5-years follow-up
To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.
At 5-years follow-up
Return to daily activities
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At baseline
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
Time Frame: At discharge, an average of 1 day
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
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At 12-months follow-up
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
Time Frame: At 24-months follow-up
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
Time Frame: At 60-months follow-up
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
Time Frame: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
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
Time Frame: At 4-5 weeks follow-up
To register intake of analgesics.
At 4-5 weeks follow-up
Intake of analgesics
Time Frame: At 12-months follow-up
To register intake of analgesics.
At 12-months follow-up
Intake of analgesics
Time Frame: At 24-months follow-up
To register intake of analgesics.
At 24-months follow-up
Intake of analgesics
Time Frame: At 60-months follow-up
To register intake of analgesics.
At 60-months follow-up
QoL
Time Frame: At baseline
To assess QoL by the EQ-5D questionnaire.
At baseline
QoL
Time Frame: At 4-5 weeks follow-up
To assess QoL by the EQ-5D questionnaire.
At 4-5 weeks follow-up
QoL
Time Frame: At 12-months follow-up
To assess QoL by the EQ-5D questionnaire.
At 12-months follow-up
QoL
Time Frame: At 24-months follow-up
To assess QoL by the EQ-5D questionnaire.
At 24-months follow-up
QoL
Time Frame: At 60-months follow-up
To assess QoL by the EQ-5D questionnaire.
At 60-months follow-up
EQ-5D change
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At 12-months follow-up
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
Time Frame: At 24-months follow-up
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
Time Frame: At 60-months follow-up
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
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At 12-months follow-up
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
Time Frame: At 24-months follow-up
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
Time Frame: At 60-months follow-up
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
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At 12-months follow-up
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
Time Frame: At 24-months follow-up
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
Time Frame: At 60-months follow-up
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
Time Frame: At 4-5 weeks follow-up
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
Time Frame: At 12-months follow-up
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
Time Frame: At 24-months follow-up
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
Time Frame: At 60-months follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cousin Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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