Back to resultsLaparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
Primary Purpose
Inguinal Hernia, Femoral Hernia
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pre-shaped 4DMESH®
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Patient is pregnant.
Sites / Locations
- Ziekenhuis Oost-Limburg GenkRecruiting
- Regionaal Ziekenhuis Heilig Hart TienenRecruiting
- AZ GroeningeRecruiting
- Hôpital Lyon Sud, Hospices Civils de LyonRecruiting
- CHU de NantesRecruiting
- CHU de ReimsRecruiting
- CH de TourcoingRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Viamed Santa Ángela de la Cruz en SevillaRecruiting
Outcomes
Primary Outcome Measures
Hernia recurrence
To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.
Secondary Outcome Measures
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.
Duration of surgery
To determine the mean duration of the surgery.
Duration of hospital stay
To determine the mean duration of hospital stay.
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.
Early recurrences
To determine the early recurrence rate 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).
Late recurrence rate
To determine the recurrence rate at 60-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call).
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 ).
Re-intervention
To determine the incidence of hernia surgery related re-interventions since the (robot-assisted) laparoscopic TEP or TAPP procedure.
Explantation rate
To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.
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.
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.
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).
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).
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).
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).
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).
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).
Intake of analgesics
To register intake of analgesics.
Intake of analgesics
To register intake of analgesics.
Intake of analgesics
To register intake of analgesics.
Intake of analgesics
To register intake of analgesics.
Intake of analgesics
To register intake of analgesics.
QoL
To assess QoL by the EQ-5D questionnaire.
QoL
To assess QoL by the EQ-5D questionnaire.
QoL
To assess QoL by the EQ-5D questionnaire.
QoL
To assess QoL by the EQ-5D questionnaire.
QoL
To assess QoL by the EQ-5D questionnaire.
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
EQ-5D change
To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better).
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).
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).
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).
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).
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Global groin symptoms
To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better).
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Impact on sex life
To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05306496
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cousin Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Femoral Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pre-shaped 4DMESH®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hernia recurrence
Description
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 Outcome Measure Information:
Title
Technical success
Description
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
Title
Duration of surgery
Description
To determine the mean duration of the surgery.
Time Frame
At index-procedure
Title
Duration of hospital stay
Description
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
Title
Peri- and post-operative complications related to 4DMESH®
Description
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
Title
Early recurrences
Description
To determine the early recurrence rate at 4-5 weeks follow-up.
Time Frame
At 4-5 weeks follow-up
Title
Late recurrence rate
Description
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
Title
Late recurrence rate
Description
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
Title
Mesh migration and mesh shrinkage
Description
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
Title
Re-intervention
Description
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
Title
Explantation rate
Description
To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure.
Time Frame
At 5-years follow-up
Title
Return to daily activities
Description
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
Title
Return to work
Description
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
Title
Pre-operative pain scoring
Description
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
Title
Post-operative pain scoring
Description
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
Title
Post-operative pain scoring
Description
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
Title
Post-operative pain scoring
Description
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
Title
Post-operative pain scoring
Description
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
Title
Post-operative pain scoring
Description
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
Title
Intake of analgesics
Description
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
Title
Intake of analgesics
Description
To register intake of analgesics.
Time Frame
At 4-5 weeks follow-up
Title
Intake of analgesics
Description
To register intake of analgesics.
Time Frame
At 12-months follow-up
Title
Intake of analgesics
Description
To register intake of analgesics.
Time Frame
At 24-months follow-up
Title
Intake of analgesics
Description
To register intake of analgesics.
Time Frame
At 60-months follow-up
Title
QoL
Description
To assess QoL by the EQ-5D questionnaire.
Time Frame
At baseline
Title
QoL
Description
To assess QoL by the EQ-5D questionnaire.
Time Frame
At 4-5 weeks follow-up
Title
QoL
Description
To assess QoL by the EQ-5D questionnaire.
Time Frame
At 12-months follow-up
Title
QoL
Description
To assess QoL by the EQ-5D questionnaire.
Time Frame
At 24-months follow-up
Title
QoL
Description
To assess QoL by the EQ-5D questionnaire.
Time Frame
At 60-months follow-up
Title
EQ-5D change
Description
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
Title
EQ-5D change
Description
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
Title
EQ-5D change
Description
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
Title
EQ-5D change
Description
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
Title
Subjective groin symptoms
Description
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
Title
Subjective groin symptoms
Description
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
Title
Subjective groin symptoms
Description
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
Title
Subjective groin symptoms
Description
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
Title
Global groin symptoms
Description
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
Title
Global groin symptoms
Description
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
Title
Global groin symptoms
Description
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
Title
Global groin symptoms
Description
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
Title
Impact on sex life
Description
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
Title
Impact on sex life
Description
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
Title
Impact on sex life
Description
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
Title
Impact on sex life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Patient is pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorien Haesen, PhD
Phone
+32 11286948
Email
dorien.haesen@archerresearch.eu
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg Genk
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Van der Speeten, Prof. Dr.
Facility Name
Regionaal Ziekenhuis Heilig Hart Tienen
City
Tienen
State/Province
Vlaams-Brabant
ZIP/Postal Code
3300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Vankeirsbilck, Dr.
Facility Name
AZ Groeninge
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu D'Hondt, Dr.
Facility Name
Hôpital Lyon Sud, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Passot, Prof. Dr.
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Blanchard-Louis, Dr.
Facility Name
CHU de Reims
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohann Renard, Prof. Dr.
Facility Name
CH de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Messager, Dr.
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ramón Naranjo Fernandez, Dr.
Facility Name
Hospital Viamed Santa Ángela de la Cruz en Sevilla
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Navarrete De Carcer, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
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