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This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.
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Inclusion criteria
22-80 years of age
Subjects have GERD with hiatal hernia < 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
Pathologic reflux while off PPI based on Lyon criteria by either of the following:
3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.
3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
Commitment to long-term study
Ability to give consent individually or by a legally authorized representative
Exclusion criteria
Primary purpose
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Interventional model
Masking
142 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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