Femoral Hernia, Inguinal Hernia
Conditions
Brief summary
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.
Interventions
DEVICEPre-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.
Sponsors
Cousin Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 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. |
| Duration of surgery | At index-procedure | To determine the mean duration of the surgery. |
| Duration of hospital stay | 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. |
| Peri- and post-operative complications related to 4DMESH® | At 5-years follow-up | To determine the rate of peri- and post-operative complications related to 4DMESH® up to 5-years follow-up. |
| Early recurrences | At 4-5 weeks follow-up | To determine the early recurrence rate at 4-5 weeks follow-up. |
| Late recurrence rate | At 24-months follow-up | To determine the recurrence rate at 24-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call). |
| Mesh migration and mesh shrinkage | 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 ). |
| Re-intervention | At 5-years follow-up | To determine the incidence of hernia surgery related re-interventions since the (robot-assisted) laparoscopic TEP or TAPP procedure. |
| Explantation rate | At 5-years follow-up | To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure. |
| Return to daily activities | 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. |
| Return to work | 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. |
| Pre-operative pain scoring | 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). |
| Post-operative pain scoring | 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). |
| Intake of analgesics | At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day | To register intake of analgesics. |
| QoL | At baseline | To assess QoL by the EQ-5D questionnaire. |
| EQ-5D change | 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). |
| Subjective groin symptoms | 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). |
| Global groin symptoms | 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). |
| Impact on sex life | At 4-5 weeks follow-up | To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better). |
Countries
Belgium, France, Spain
Outcome results
None listed