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.
Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)
Written informed consent
≥ 18 years of age
> 5cm hiatal hernia
Lack of patient consent for study participation
Lack of consent to study due to linguistic or mental incomprehension
Patients in poor general condition (lack of anesthesia ability)
Pregnancy
Paracelsus Medical University
Lead sponsor
Medical University Innsbruck
Collaborator
Medical University of Vienna
Collaborator
Krankenhaus Barmherzige Schwestern Linz
Collaborator
Elisabethinen Hospital
Collaborator