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Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Aug 2023 to Dec 2026
    • Study completion date: Aug 2028 to Aug 2027
    v8
  2. Primary completion date: May 2022 to Aug 2023
    • Study completion date: May 2025 to Aug 2028
    v7
  3. Primary completion date: May 2020 to May 2022
    • Study completion date: May 2023 to May 2025
    v6
  4. Primary completion date: May 2019 to May 2020v5
  5. Start date: May 2016 to May 9, 2016v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Interventions: LiquiBand Fix8 glue fixation (Procedure) to LiquiBand Fix8 glue fixation (Procedure), No-fixation (Procedure)
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT02781870
Lead Sponsor Algemeen Ziekenhuis Maria Middelares
Collaborators: Duomed
Conditions
(from sponsor)		 Hernia, Recurrence
Related terms Hernia, Recurrence
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov