Gastropexy as a Treatment Option for Paraesophageal Hernia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adults with a paraesophageal hernia with indication of operation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • no intervention, but surgical practice as usual is continued. Its a pragmatic study

    Procedure/Surgery

    no intervention

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: anterior gastropexy, no fundoplication1 intervention
Group B: anterior gastropexy and fundoplication1 intervention

Trial outcomes

Primary outcomes

1

peri- and postoperative complications

according to clavien-dindo score

Time frame
30 days after operation
2

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

Time frame
Before surgery and 3,6 and 12 months after surgery
3

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

Time frame
before surgery and 3, 6 and 12 months after surgery

Secondary outcomes

1

Total number of patients with radiological recurrence after one year

esophagus x-ray/barium swallow one year after surgery

Time frame
one year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: