Surgery for paraesophageal hernias with or without gastropexy
Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial
This study is testing whether adding a stomach-fixing procedure during surgery for paraesophageal hernias helps patients recover better than just the standard surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ersta Diakoni Academic / other |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT06107634 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves patients scheduled for surgery to repair primary paraesophageal hernias. Participants are randomized into two groups: one receiving conventional surgical repair and the other receiving the same repair with the addition of gastropexy, which fixes parts of the stomach and diaphragm. Follow-up assessments include imaging and patient-reported outcomes to evaluate the effectiveness of the interventions over time.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with primary paraesophageal hernias who are scheduled for surgical repair.
Not a fit: Patients with previous major upper gastrointestinal surgery or significant esophageal motility disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with paraesophageal hernias.
How similar studies have performed: While similar surgical approaches have been explored, the specific combination of gastropexy with paraesophageal hernia repair is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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 Criteria: * 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.
Where this trial is running
Gothenburg and 5 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Skåne University Hospital Lund — Lund, Sweden (Not_yet_recruiting)
- Nyköping Hospital — Nyköping, Sweden (Recruiting)
- Ersta Hospital — Stockholm, Sweden (Recruiting)
- Sundsvall County Hospital — Sundsvall, Sweden (Recruiting)
- Uppsala Academic Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Marcus Reuterwall Hansson, PhD
- Email: marcus.reuterwall.hansson@ki.se
- Phone: +466147500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.