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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306496
• Other study ID #: RAPID4D
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: September 30, 2029

Study information

• Verified date: April 2024
• Source: Cousin Biotech
• Contact: Dorien Haesen, PhD
• Phone: +32 11286948
• Email: dorien.haesen[@]archerresearch.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2029
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Hernia
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg Genk	Genk	Limburg
Belgium	AZ Groeninge	Kortrijk	West-Vlaanderen
Belgium	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen	Vlaams-Brabant
France	Hôpital Lyon Sud, Hospices Civils de Lyon	Lyon
France	CHU de Nantes	Nantes
France	CHU de Reims	Reims cedex
France	CH de Tourcoing	Tourcoing
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Viamed Santa Ángela de la Cruz en Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Cousin Biotech

Countries where clinical trial is conducted

Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of surgery	To determine the mean duration of the surgery.	At index-procedure
Secondary	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
Secondary	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
Secondary	Early recurrences	To determine the early recurrence rate at 4-5 weeks follow-up.	At 4-5 weeks follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Explantation rate	To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.	At 5-years follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intake of analgesics	To register intake of analgesics.	At 4-5 weeks follow-up
Secondary	Intake of analgesics	To register intake of analgesics.	At 12-months follow-up
Secondary	Intake of analgesics	To register intake of analgesics.	At 24-months follow-up
Secondary	Intake of analgesics	To register intake of analgesics.	At 60-months follow-up
Secondary	QoL	To assess QoL by the EQ-5D questionnaire.	At baseline
Secondary	QoL	To assess QoL by the EQ-5D questionnaire.	At 4-5 weeks follow-up
Secondary	QoL	To assess QoL by the EQ-5D questionnaire.	At 12-months follow-up
Secondary	QoL	To assess QoL by the EQ-5D questionnaire.	At 24-months follow-up
Secondary	QoL	To assess QoL by the EQ-5D questionnaire.	At 60-months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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