Gastropexy as a Treatment Option for Paraesophageal Hernia

NCT06096402 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2023-10-23

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096402 on ClinicalTrials.gov