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

NANot yet recruitingINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

May 1, 2027

Study Completion Date

May 1, 2027

Conditions
Hiatal Hernia
Interventions
DEVICE

Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet

Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.

All Listed Sponsors
collaborator

Medical University Innsbruck

OTHER

collaborator

Medical University of Vienna

OTHER

collaborator

Krankenhaus Barmherzige Schwestern Linz

OTHER

collaborator

Elisabethinen Hospital

OTHER

lead

Paracelsus Medical University

OTHER

NCT04591860 - A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only | Biotech Hunter | Biotech Hunter