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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
142
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
University of California Irvine
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mean difference in HRQL score ≤ 15%
Hypothesis: TIF is non-inferior to LNF as measured by quality of life at 6 months post-procedure using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score. GERD-HRQL Scoring Total Score: Calculated by summing the individual scores to questions 1-15. * Greatest possible score (worst symptoms) = 75 * Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . * Worst heartburn symptoms = 30 * No heartburn symptoms = 0 * Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions 10-15. * Worst regurgitation symptoms = 30 * No regurgitation symptoms = 0 * Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Time frame: 6 months
Change in AET
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Time frame: [Time Frame: 6 months]
Incidence of bloating
Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form
Time frame: [Time Frame: 6 months]
Incidence of dysphagia
Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form
Time frame: [Time Frame: 6 months]
Change in distensibility index of GE junction
Endoflip (optional) Case Report Form
Time frame: [Time Frame: 6 months]
Cessation of Proton Pump Inhibitor (PPI) use
PPI Use Questionnaire Case Report Form
Time frame: [Time Frame: 6 months]
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The University of Texas at Austin
Austin, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Fox Valley Surgical
Appleton, Wisconsin, United States
Healing of esophagitis
Upper Endoscopy with 72 Hrs BravoPH Case Report Form assessing LA Grade system: A, B, C, or D (if present) Grade A One (or more) mucosal break no longer than 5 mm that does not extend between the tops of two mucosal folds Grade B One (or more) mucosal break more than 5 mm long that does not extend between the tops of two mucosal folds Grade C One (or more) mucosal break that is continuous between the tops of two or more mucosal folds but which involve less than 75% of the circumference Grade D One (or more) mucosal break which involves at least 75% of the esophageal circumference
Time frame: [Time Frame: 6 months]
Recurrence of hiatal hernia
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Time frame: [Time Frame: 6 months]
Hill grade of GE junction
Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Time frame: [Time Frame: 6 months]
Adverse events rate
Adverse Event Case Report Form
Time frame: [Time Frame: 6 months]