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

Study Overview
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Brief Summary
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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
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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

Conditions
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GERD, Hiatal Hernia

Intervention / Treatment
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* Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION


Participation Criteria
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Eligibility Criteria
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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. Severe gastroparesis

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Nissen Fundoplication (LNF)<br>Control | Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION<br>* LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION<br>* Other names: LAPAROSCOPIC NISSEN FUNDOPLICATION;|
| Active Comparator: Combo Transoral Incisionless Fundoplication (CTIF)<br>Treatment | Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION<br>* LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION<br>* Other names: LAPAROSCOPIC NISSEN FUNDOPLICATION;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AET | Upper Endoscopy with 72 Hrs BravoPH Case Report Form | [Time Frame: 6 months] | 
| Incidence of bloating | Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form | [Time Frame: 6 months] | 
| Incidence of dysphagia | Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form | [Time Frame: 6 months] | 
| Change in distensibility index of GE junction | Endoflip (optional) Case Report Form | [Time Frame: 6 months] | 
| Cessation of Proton Pump Inhibitor (PPI) use | PPI Use Questionnaire Case Report Form | [Time Frame: 6 months] | 
| 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: 6 months] | 
| Recurrence of hiatal hernia | Upper Endoscopy with 72 Hrs BravoPH Case Report Form | [Time Frame: 6 months] | 
| Hill grade of GE junction | Upper Endoscopy with 72 Hrs BravoPH Case Report Form | [Time Frame: 6 months] | 
| Adverse events rate | Adverse Event Case Report Form | [Time Frame: 6 months] |