Gastropexy as a Treatment Option for Paraesophageal Hernia
NCT06096402 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220
Last updated 2023-10-23
Summary
The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. The incidence of PEH increases with age and the older patient typically has additional co-morbidities, reduced physiological fitness, and frailty which makes surgery challenging regarding increased morbidity and mortality. Thus, the decision to offer surgery can be challenging in this cohort of patients. The need of an anti-reflux procedure as part of the repair is one of the main subjects for discussion worldwide. To date no consensus exists and many surgical centres do a routine anti-reflux procedure as part of their standard operation for PEH. But is this procedure redundant? Can the patients be managed with a less complicated procedure; an anterior gastropexy with comparable outcome?
Conditions
- Paraesophageal Hernia
Interventions
- PROCEDURE
-
no intervention, but surgical practice as usual is continued. Its a pragmatic study
no intervention
Sponsors & Collaborators
-
Hvidovre University Hospital
collaborator OTHER -
St. Olavs Hospital
collaborator OTHER -
University Hospital of North Norway
lead OTHER
Principal Investigators
-
Kim Erlend Mortensen, MD, PhD · University of North Norway
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- Denmark
- Norway
Study Locations
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