Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiata… (NCT04795934) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
United States142 participantsStarted 2021-01-26
Plain-language 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.
Who can participate
Age range22 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓.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
Exclusion criteria
✕. 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.