Paraesophageal Hernia Clinical Trial
Official title:
Selective Anterior Gastropexy as a Surgical Treatment Option for Paraesophageal Hernia
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?
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Both emergent and elective repair of the paraoesophageal hernia Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Copenhagen | |
Norway | University Hospital of North Norway | Harstad | |
Norway | St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | Hvidovre University Hospital, St. Olavs Hospital |
Denmark, Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | peri- and postoperative complications | according to clavien-dindo score | 30 days after operation | |
Primary | Gastro-esophageal reflux disease-Health related quality of life, GERD-HRQL | The GERD-HRQL questionnaire evaluates heartburn, dysphagia and regurgitation on a scale from zero (no symptoms) to five (severe symptoms) in 15 questions. Maximum score ranges from zero to 75 points | Before surgery and 3,6 and 12 months after surgery | |
Primary | Short From questionnaire (SF-36) Health related quality of life | SF-36 is a well-established questionnaire consisting of 36 health related questions. Scale is from 0-100 for each section (8 sections) A high score corresponds to a better health status | before surgery and 3, 6 and 12 months after surgery | |
Secondary | Total number of patients with radiological recurrence after one year | esophagus x-ray/barium swallow one year after surgery | one year after surgery |
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