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

N/AActive Not RecruitingNCT05306496

Cousin Biotech196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

196

Conditions

Inguinal Hernia Femoral Hernia

Interventions

Pre-shaped 4DMESH®DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (9)

Ziekenhuis Oost-Limburg Genk

Genk, Limburg, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Vlaams-Brabant, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

Hôpital Lyon Sud, Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

Hernia recurrence

To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.

Time frame: At 12-months follow-up

Secondary Outcomes

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.

Time frame: At index-procedure

Duration of surgery

To determine the mean duration of the surgery.

Time frame: At index-procedure

Duration of hospital stay

To determine the mean duration of hospital stay.

Time frame: 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.

Time frame: At 5-years follow-up

Early recurrences

To determine the early recurrence rate at 4-5 weeks follow-up.

Time frame: 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).

Time frame: At 24-months follow-up

Data from ClinicalTrials.gov

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CHU de Nantes

Nantes, France

CHU de Reims

Reims, France

CH de Tourcoing

Tourcoing, France

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Viamed Santa Ángela de la Cruz en Sevilla

Seville, Spain

Late recurrence rate

To determine the recurrence rate at 60-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).

Time frame: 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 ).

Time frame: 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.

Time frame: At 5-years follow-up

Explantation rate

To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: At 60-months follow-up

Intake of analgesics

To register intake of analgesics.

Time frame: 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.

Time frame: At 4-5 weeks follow-up

Intake of analgesics

To register intake of analgesics.

Time frame: At 12-months follow-up

Intake of analgesics

To register intake of analgesics.

Time frame: At 24-months follow-up

Intake of analgesics

To register intake of analgesics.

Time frame: At 60-months follow-up

QoL

To assess QoL by the EQ-5D questionnaire.

Time frame: At baseline

QoL

To assess QoL by the EQ-5D questionnaire.

Time frame: At 4-5 weeks follow-up

QoL

To assess QoL by the EQ-5D questionnaire.

Time frame: At 12-months follow-up

QoL

To assess QoL by the EQ-5D questionnaire.

Time frame: At 24-months follow-up

QoL

To assess QoL by the EQ-5D questionnaire.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: At 60-months follow-up