The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

Study acronym: LJUNO
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Phase: Phase 2/3 to Not applicablev8 Show 8 more changesShow less
    • Primary completion date changed from estimate of May 2016 to Apr 2019
    • Study completion date changed from estimate of Nov 2016 to Apr 2019
    • Primary endpoints: 2 to 4
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 400 to confirmed 412
    • Start date: Dec 2006 to Sep 2006
    • Secondary endpoints: 4 to 8
    • Publications: details revised at 1 of 2 entries
  2. Study completion date: May 2016 to Nov 2016v7
  3. Primary and study completion dates pushed to May 2016
    • Study sites revised (2)
    • Collaborators: 2 to 3
    v6
  4. Primary completion date changed from estimate of Feb 2010 to May 2011
    • Study completion date: Dec 2011
    v5
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jan 2010 to Feb 2010
    • Site details revised at 2 of 2 sites
    v4
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  1. Primary completion date: Jan 2010
    • Secondary endpoints: details revised at 4 of 4 entries
    v3
  2. Study arms: 0 to 2v2
  1. Study First Submitted
  • 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.
The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes. Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.
Trial Details
NCT Number NCT00451893
Lead Sponsor Umeå University
Collaborators: Norrlandstingens Regionförbund, Jämtland County Council, Sweden, Västerbotten County Council, Sweden
Conditions
(from sponsor)		 Inguinal Hernia
Related terms Hernia, Inguinal
Enrollment 412 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov