GERD, Hiatal Hernia
Conditions
Brief 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.
Interventions
PROCEDURELAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
Sponsors
Mayo Clinic
EndoGastric Solutions
University of California, Irvine
Fox Valley Surgical Associates
University of Southern California
The University of Texas Health Science Center, Houston
University of Texas at Austin
Institute of Esophageal and Reflux Surgery
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 22-80 years of age 2. 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 3. 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. 4. Commitment to long-term study 5. Ability to give consent individually or by a legally authorized representative
Exclusion criteria
1. 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) 2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator 3. Pregnancy (in females) at time of procedure 4. Previous anti-reflux procedure 5. Subjects requiring mesh treatment at time of procedure 6. At the discretion of the site PI for subject safety 7. BMI \> 35 at time of surgery. 8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty. 9. Severe gastroparesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in HRQL score ≤ 15% | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AET | [Time Frame: 6 months] | Upper Endoscopy with 72 Hrs BravoPH Case Report Form |
| Incidence of bloating | [Time Frame: 6 months] | Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form |
| Incidence of dysphagia | [Time Frame: 6 months] | Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form |
| Change in distensibility index of GE junction | [Time Frame: 6 months] | Endoflip (optional) Case Report Form |
| Cessation of Proton Pump Inhibitor (PPI) use | [Time Frame: 6 months] | PPI Use Questionnaire Case Report Form |
| Healing of esophagitis | [Time Frame: 6 months] | 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 |
| Recurrence of hiatal hernia | [Time Frame: 6 months] | Upper Endoscopy with 72 Hrs BravoPH Case Report Form |
| Hill grade of GE junction | [Time Frame: 6 months] | Upper Endoscopy with 72 Hrs BravoPH Case Report Form |
| Adverse events rate | [Time Frame: 6 months] | Adverse Event Case Report Form |
Countries
United States
Outcome results
None listed