NCT05807763

Fundoplication in Laparoscopic PEH Repair Based on FLIP

Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: The Foundation for Surgical Innovation and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Prospective Randomized Controlled Trial in which patients who meet criteria will be randomized to receive a concurrent fundoplication or no fundoplication at the time of paraesophageal hernia repair. Patients with known objective gastroesophageal reflux disease prior to surgery, those found to have a short esophagus in the operating room or defective gastroesophageal reflux barrier by intra-operative impedance planimetry measurements and/or endoscopic valve grade will be excluded.

Conditions

• Paraesophageal Hernia

Interventions

Type	Name	Description
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".

Timeline

• Start date: 2023-02-22
• Primary completion: 2025-02-22
• Completion: 2029-02-22
• First posted: 2023-04-11
• Last updated: 2024-11-27

Locations

2 sites across 1 country: United States