Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
- Conditions
- Femoral HerniaInguinal Hernia
- Registration Number
- NCT05306496
- Lead Sponsor
- Cousin Biotech
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Duration of surgery At index-procedure To determine the mean duration of the surgery.
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 ).
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.
EQ-5D change 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).
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 60-months follow-up To determine the recurrence rate at 60-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).
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.
Intake of analgesics At 60-months follow-up To register intake of analgesics.
QoL At 60-months follow-up To assess QoL by the EQ-5D questionnaire.
Global groin symptoms At 60-months follow-up To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Post-operative pain scoring 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).
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).
Subjective groin symptoms 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).
Impact on sex life At 60-months follow-up To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Trial Locations
- Locations (9)
Regionaal Ziekenhuis Heilig Hart Tienen
🇧🇪Tienen, Vlaams-Brabant, Belgium
Ziekenhuis Oost-Limburg Genk
🇧🇪Genk, Limburg, Belgium
AZ Groeninge
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Hôpital Lyon Sud, Hospices Civils de Lyon
🇫🇷Lyon, France
CHU de Nantes
🇫🇷Nantes, France
CH de Tourcoing
🇫🇷Tourcoing, France
CHU de Reims
🇫🇷Reims cedex, France
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Viamed Santa Ángela de la Cruz en Sevilla
🇪🇸Sevilla, Spain