Status:
RECRUITING
Gastropexy in the Repair of Patients with Paraesophageal Hernias
Lead Sponsor:
Ersta Diakoni
Collaborating Sponsors:
Göteborg University
Sundsvall Hospital
Conditions:
Paraesophageal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.
Detailed Description
Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group. Control Group: Patients undergo a crural repair combi...
Eligibility Criteria
Inclusion
- \- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers
Exclusion
- Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
- Diagnosis of achalasia or any other significant esophageal motility disorder.
- Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
- Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2030
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06107634
Start Date
June 1 2023
End Date
August 2 2030
Last Update
December 18 2024
Active Locations (6)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
2
Skåne University Hospital Lund
Lund, Sweden, 221 85
3
Nyköping Hospital
Nyköping, Sweden, 611 85
4
Ersta Hospital
Stockholm, Sweden, 11691