The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia

Study acronym: PEH2
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2026 to Mar 22, 2024
    • Enrollment target: estimated 70 to confirmed 74
    • Study completion date changed from estimate of Dec 31, 2026 to Jun 17, 2025
    • Secondary endpoints: details revised at 3 of 6 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria revised
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.
Trial Details
NCT Number NCT04179578
Lead Sponsor Karolinska Institutet
Conditions
(from sponsor)		 Paraesophageal Hernia
Related terms Hernia, Hiatal
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov