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

Study Overview
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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.

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

Conditions
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Inguinal Hernia, Femoral Hernia

Intervention / Treatment
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* Device: Pre-shaped 4DMESH®


Participation Criteria
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Eligibility Criteria
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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. Patient is pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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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 |