Gastropexy as a Treatment Option for Paraesophageal Hernia

NCT06096402 | Not Yet Recruiting

• 1 other identifier: 625668 (REK)
• Study Type: observational
• Target: 220
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

paraesophageal hernia; gastropexy; fundoplication

Outcome Measures

Primary Outcomes (3)

• peri- and postoperative complications

  according to clavien-dindo score

  30 days after operation

• 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

• 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 Outcomes (1)

• Total number of patients with radiological recurrence after one year

  one year after surgery

Study Arms (2)

anterior gastropexy, no fundoplication

patients with indication of operative management of a paraesophageal hernia

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

anterior gastropexy and fundoplication

patients with indication of operative management of a paraesophageal hernia

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

Interventions

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

no intervention

anterior gastropexy and fundoplication; anterior gastropexy, no fundoplication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with a paraesophageal hernia with indication of operation

You may qualify if:

• \- Both emergent and elective repair of the paraoesophageal hernia

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Hvidovre University Hospital: collaborator
• St. Olavs Hospital: collaborator

Study Sites (3)

Hvidovre Hospital

Copenhagen, Denmark

Location

University Hospital of North Norway

Harstad, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Erlend Mortensen, MD, PhD

  University of North Norway

  STUDY DIRECTOR

Central Study Contacts

Lene Osterballe, MD

CONTACT

+4797572401; lene.osterballe@unn.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 23, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

NO (2); DK (1)