Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

Running, not enrolling · Not applicable

Conditions studied: GERD, Hiatal Hernia

In brief

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.

Key facts

Study ID

NCT04795934

Run by

Mayo Clinic

People needed

142

Starts

2021-01-26

Expected to finish

2030-01-01

Last updated by the study team

2025-08-19

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.
• 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

You may not qualify if…

• 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)
• Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
• Pregnancy (in females) at time of procedure
• Previous anti-reflux procedure
• Subjects requiring mesh treatment at time of procedure
• At the discretion of the site PI for subject safety
• BMI > 35 at time of surgery.
• Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
• Severe gastroparesis

Where it is running

• 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

Full record on ClinicalTrials.gov

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