The Foundation for Surgical Innovation and Education
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.
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.
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
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".
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