NCT02781870

Brief Summary

This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and 12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh placement versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic treatment of groin hernias. A total of 100 male and female patients will be entered in the trial in Maria Middelares Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the department of surgery will screen all eligible consecutive patients for inclusion in the study. They will inform all patients about the surgery and the follow-up with MRI scan thereafter.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2016Aug 2027

Study Start

First participant enrolled

May 9, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

10.6 years

First QC Date

May 10, 2016

Last Update Submit

April 10, 2025

Conditions

HerniaRecurrence

Outcome Measures

Primary Outcomes (1)

  • visualization of mesh surface

    Visualization of the mesh surface at 12 months postoperative observed with MRI scan rate after laparoscopic repair of unilateral inguinal hernias using the 3D-Endolap visible mesh with or without LiquiBand® Fix 8™ glue fixation.

    12 months

Secondary Outcomes (2)

  • visualization of mesh surface

    1 month

  • recurrence of inguinal hernia

    1 month, 12 months, 36 months and 60 months

Other Outcomes (1)

  • Quality of Life assessment

    1 month, 12 months, 36 months and 60 months

Study Arms (2)

No-fixation

OTHER

These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible without fixation.

Procedure: No-fixation

LiquiBand Fix glue fixation

EXPERIMENTAL

These patients will be randomized during the operation, at the time of mesh placement to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation. Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.

Procedure: LiquiBand Fix8 glue fixation

Interventions

LiquiBand Fix8 glue fixationPROCEDURE

Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.

Also known as: LiquiBand Fix8 glue
LiquiBand Fix glue fixation
No-fixationPROCEDURE

Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.

No-fixation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients presenting with primary unilateral inguinal hernia
  • patients planed for a laparoscopic repair

You may not qualify if:

  • Age below 18 years
  • recurrent or incarcerated hernias
  • open hernia repair and bilateral hernias
  • concomitant repair of another kind of abdominal hernia
  • combined surgical procedures
  • no informed consent
  • pregnant women
  • ASA score 4 or more
  • contra-indications for MRI scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Related Publications (2)

  • Mayer F, Niebuhr H, Lechner M, Dinnewitzer A, Kohler G, Hukauf M, Fortelny RH, Bittner R, Kockerling F. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016 Oct;30(10):4363-71. doi: 10.1007/s00464-016-4754-8. Epub 2016 Feb 17.

    PMID: 26886454BACKGROUND

  • Klobusicky P, Feyerherd P. Innovation in Laparoscopic Inguinal Hernia Reparation - Initial Experiences with the Parietex Progrip Laparoscopic() - Mesh. Front Surg. 2015 Jun 25;2:28. doi: 10.3389/fsurg.2015.00028. eCollection 2015.

    PMID: 26161386BACKGROUND

MeSH Terms

Conditions

HerniaRecurrence

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Filip Muysoms, MD, PhD

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Filip Muysoms, MD, PhD

CONTACT

0032-92467400filip.muysoms@azmmsj.be

Iris Kyle-Leinhase, PhD

CONTACT

+3292467451iris.kyle-leinhase@azmmsj.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
abdominal wall surgeon

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 25, 2016

Study Start

May 9, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)