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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
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".
NorthShore University HealthSystem
Evanston, Illinois, United States
Providence Portland Medical Center / The Oregon Clinic
Portland, Oregon, United States
Number of participants with GERD post-op
Patients will undergo endoscopic evaluation and 48 hour pH testing to determine the incidence of objective GERD with and without fundoplication after PEH repair.
Time frame: 12 months
Number of participants with hernia recurrence
Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence
Time frame: 12 months
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