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NCT Number: NCT05306496

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Inguinal Hernia Femoral Hernia Hernia Hernia, Abdominal Hernia, Femoral Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg Genk, Genk, Limburg, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Pre-shaped 4DMESH®

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Duration of surgery

    Time frame: At index-procedure

    To determine the mean duration of the surgery.

  3. 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.

  4. 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.

  5. Early recurrences

    Time frame: At 4-5 weeks follow-up

    To determine the early recurrence rate at 4-5 weeks follow-up.

  6. 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).

  7. 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).

  8. 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 ).

  9. 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.

  10. Explantation rate

    Time frame: At 5-years follow-up

    To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.

  11. 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.

  12. 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.

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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.

  20. Intake of analgesics

    Time frame: At 4-5 weeks follow-up

    To register intake of analgesics.

  21. Intake of analgesics

    Time frame: At 12-months follow-up

    To register intake of analgesics.

  22. Intake of analgesics

    Time frame: At 24-months follow-up

    To register intake of analgesics.

  23. Intake of analgesics

    Time frame: At 60-months follow-up

    To register intake of analgesics.

  24. QoL

    Time frame: At baseline

    To assess QoL by the EQ-5D questionnaire.

  25. QoL

    Time frame: At 4-5 weeks follow-up

    To assess QoL by the EQ-5D questionnaire.

  26. QoL

    Time frame: At 12-months follow-up

    To assess QoL by the EQ-5D questionnaire.

  27. QoL

    Time frame: At 24-months follow-up

    To assess QoL by the EQ-5D questionnaire.

  28. QoL

    Time frame: At 60-months follow-up

    To assess QoL by the EQ-5D questionnaire.

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. 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).

  36. 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).

  37. 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).

  38. 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).

  39. 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).

  40. 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).

  41. 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).

  42. 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).

  43. 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).

  44. 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).

Sponsors and collaborators

Lead sponsor

Cousin Biotech

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2029
First posted
Apr 1, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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