Fundoplication in Laparoscopic PEH Repair Based on FLIP (PEHFLIP)

The Foundation for Surgical Innovation and Education

Status

Invitation-only

Conditions

Paraesophageal Hernia

Treatments

Procedure: Laparoscopic paraesophageal hernia repair without fundoplication

Study type

Interventional

Funder types

Other

Identifiers

NCT05807763

STUDY2022000698

Details and patient eligibility

About

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.

Full 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.

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients undergoing laparoscopic paraesophageal hernia repair

Exclusion criteria

History of a prior hiatal hernia/paraesophageal hernia repair
Patients with objective GERD preoperatively
Intra-operative short esophagus
Defective gastroesophageal reflux barrier as determined by impedance planimetry (FLIP)
Defective gastroesophageal reflux barrier as determined by intra-operative endoscopy