Fundoplication in Laparoscopic PEH Repair Based on FLIP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Paraesophageal Hernia

Intervention / Treatment
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* Procedure: Laparoscopic paraesophageal hernia repair without fundoplication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Fundoplication | |
| Experimental: Study Group<br>No Fundoplication | Procedure: Laparoscopic paraesophageal hernia repair without fundoplication<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD | Patients will undergo endoscopic evaluation and 48 hour pH testing to determine the incidence of objective GERD with and without fundoplication after PEH repair. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hernia recurrence | Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paraesophageal hernia repair, Laparoscopic paraesophageal hernia repair, PEH repair, Lap PEH repair, FLIP, Functional luminal imaging probe, GERD, Gastroesophageal Reflux Disease