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Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
Sponsor: Mayo Clinic
Summary
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.
Official title: Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair Combined With Transoral Incisionless Fundoplication Versus Laparoscopic Nissen Fundoplication for Treatment of Gastroesophageal Reflux Disease in Patients Requiring Hiatal Hernia Repair
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2021-01-26
Completion Date
2030-01
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
Locations (7)
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
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