Multicenter Single-blind Randomized Controlled Trial Of Laparoscopic Paraesophageal Hiatal Hernia Repair Combined With Transoral Incisionless Fundoplication Versus Laparoscopic Nissen Fundoplication For Treatment Of Gastroesophageal Reflux Disease In Patients Requiring Hiatal Hernia Repair
Details
Measures will be taken to minimize or avoid bias in the study "masking/blinding procedures." Neither treatment groups will be advised as to which procedure (TIF or LNF) they will be receiving. Randomization assignment will be recorded in the EDC and subject tracking, but will not be recorded within the EMR to reduce clinical team exposure to their randomized status for follow-up care. Research teams will not be blinded to the randomization results.
Eligibility
You can join if...
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:
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.