NCT05807763View on ClinicalTrials.gov

Fundoplication in Laparoscopic PEH Repair Based on FLIP

NAEnrolling by invitationINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

February 22, 2023

Primary Completion Date

February 22, 2025

Study Completion Date

February 22, 2029

Conditions
Paraesophageal Hernia
Interventions
PROCEDURE

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."

Trial Locations (2)

60201

NorthShore University HealthSystem, Evanston

97213

Providence Portland Medical Center / The Oregon Clinic, Portland

All Listed Sponsors
lead

The Foundation for Surgical Innovation and Education

OTHER