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Fundoplication in Laparoscopic PEH Repair Based on FLIP
Sponsor: The Foundation for Surgical Innovation and Education
Summary
Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.
Official title: Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2023-02-22
Completion Date
2029-02-22
Last Updated
2024-11-27
Healthy Volunteers
Yes
Conditions
Interventions
Laparoscopic paraesophageal hernia repair without fundoplication
Patients undergoing laparoscopic paraesophageal hernia repair will be evaluated for risk of esophageal reflux using intra-operative impedance planimetry and endoscopic gastroesophageal valve grade. Patients deemed low risk for esophageal reflux will then be randomized to "partial fundoplication" or "no fundoplication".
Locations (2)
NorthShore University HealthSystem
Evanston, Illinois, United States
Providence Portland Medical Center / The Oregon Clinic
Portland, Oregon, United States