An interventional study of Laparoscopic paraesophageal hernia repair without fundoplication in Paraesophageal Hernia, sponsored by The Foundation for Surgical Innovation and Education. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by The Foundation for Surgical Innovation and Education · Not applicable, Interventional, and Treatment
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 260 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →This is the only study on the registry with The Foundation for Surgical Innovation and Education as lead sponsor.
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Exclusion Criteria:
Fundoplication
No Fundoplication
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".
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
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Feb 2025, 24 months after the start.
Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's planned 24 months is below that.
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