About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults with a paraesophageal hernia with indication of operation
Trial design
Cohort
Prospective
Treatments tested in this trial
no intervention, but surgical practice as usual is continued. Its a pragmatic study
Procedure/Surgeryno intervention
Treatment groups
Trial outcomes
Primary outcomes
peri- and postoperative complications
according to clavien-dindo score
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
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
Secondary outcomes
Total number of patients with radiological recurrence after one year
esophagus x-ray/barium swallow one year after surgery
Sponsors and contacts
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University Hospital of North Norway
Lead sponsor
Hvidovre University Hospital
Collaborator
St. Olavs Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: