Clinical trial NCT05306496: Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
Official title: Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Femoral Hernia
Lead sponsor: Cousin Biotech
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Hernia recurrence
timeFrame: At 12-months follow-up
Secondary outcomes:
measure: Technical success
timeFrame: At index-procedure
measure: Duration of surgery
timeFrame: At index-procedure
measure: Duration of hospital stay
timeFrame: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
measure: Peri- and post-operative complications related to 4DMESH®
timeFrame: At 5-years follow-up
measure: Early recurrences
timeFrame: At 4-5 weeks follow-up
measure: Late recurrence rate
timeFrame: At 24-months follow-up
measure: Late recurrence rate
timeFrame: At 60-months follow-up
measure: Mesh migration and mesh shrinkage
timeFrame: At 12-months follow-up
measure: Re-intervention
timeFrame: At 5-years follow-up
measure: Explantation rate
timeFrame: At 5-years follow-up
measure: Return to daily activities
timeFrame: At 4-5 weeks follow-up
measure: Return to work
timeFrame: At 4-5 weeks follow-up
measure: Pre-operative pain scoring
timeFrame: At baseline
measure: Post-operative pain scoring
timeFrame: At discharge, an average of 1 day
measure: Post-operative pain scoring
timeFrame: At 4-5 weeks follow-up
measure: Post-operative pain scoring
timeFrame: At 12-months follow-up
measure: Post-operative pain scoring
timeFrame: At 24-months follow-up
measure: Post-operative pain scoring
timeFrame: At 60-months follow-up
measure: Intake of analgesics
timeFrame: At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day
measure: Intake of analgesics
timeFrame: At 4-5 weeks follow-up
measure: Intake of analgesics
timeFrame: At 12-months follow-up
measure: Intake of analgesics
timeFrame: At 24-months follow-up
measure: Intake of analgesics
timeFrame: At 60-months follow-up
measure: QoL
timeFrame: At baseline
measure: QoL
timeFrame: At 4-5 weeks follow-up
measure: QoL
timeFrame: At 12-months follow-up
measure: QoL
timeFrame: At 24-months follow-up
measure: QoL
timeFrame: At 60-months follow-up
measure: EQ-5D change
timeFrame: At 4-5 weeks follow-up
measure: EQ-5D change
timeFrame: At 12-months follow-up
measure: EQ-5D change
timeFrame: At 24-months follow-up
measure: EQ-5D change
timeFrame: At 60-months follow-up
measure: Subjective groin symptoms
timeFrame: At 4-5 weeks follow-up
measure: Subjective groin symptoms
timeFrame: At 12-months follow-up
measure: Subjective groin symptoms
timeFrame: At 24-months follow-up
measure: Subjective groin symptoms
timeFrame: At 60-months follow-up
measure: Global groin symptoms
timeFrame: At 4-5 weeks follow-up
measure: Global groin symptoms
timeFrame: At 12-months follow-up
measure: Global groin symptoms
timeFrame: At 24-months follow-up
measure: Global groin symptoms
timeFrame: At 60-months follow-up
measure: Impact on sex life
timeFrame: At 4-5 weeks follow-up
measure: Impact on sex life
timeFrame: At 12-months follow-up
measure: Impact on sex life
timeFrame: At 24-months follow-up
measure: Impact on sex life
timeFrame: At 60-months follow-up
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg Genk
state: Limburg
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Lyon
country: France
facility: Hôpital Lyon Sud, Hospices Civils de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Reims cedex
country: France
facility: CHU de Reims
city: Tourcoing
country: France
facility: CH de Tourcoing
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Viamed Santa Ángela de la Cruz en Sevilla
Study officials:
References: