Clinical Trial

A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

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Summary
A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh). The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-10-12; most recent amendment 2024-04-01.
Trial Details
NCT Number NCT04591860
Lead Sponsor Paracelsus Medical University
Collaborators: Medical University Innsbruck, Medical University of Vienna, Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital
Conditions Hiatal Hernia
Enrollment 165 participants
Start Date 2024-05-01
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-04-02