Not Yet RecruitingNot Applicable

Gastropexy as a Treatment Option for Paraesophageal Hernia

Denmark, Norway220 participantsStarted 2024-06-01

Plain-language 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?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Both emergent and elective repair of the paraoesophageal hernia Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

peri- and postoperative complications

Timeframe: 30 days after operation

Gastro-esophageal reflux disease-Health related quality of life, GERD-HRQL

Timeframe: Before surgery and 3,6 and 12 months after surgery

Short From questionnaire (SF-36) Health related quality of life

Timeframe: before surgery and 3, 6 and 12 months after surgery

Trial details

NCT IDNCT06096402

SponsorUniversity Hospital of North Norway

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Lene Osterballe, MD

+4797572401 lene.osterballe@unn.no

View on ClinicalTrials.gov More Paraesophageal Hernia trials