Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
CTIF
1 other identifier
interventional
142
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2021
CompletedFirst Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
ExpectedAugust 19, 2025
August 1, 2025
4.5 years
February 10, 2021
August 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Change in AET
[Time Frame: 6 months]
Incidence of bloating
[Time Frame: 6 months]
Incidence of dysphagia
[Time Frame: 6 months]
Change in distensibility index of GE junction
[Time Frame: 6 months]
Cessation of Proton Pump Inhibitor (PPI) use
[Time Frame: 6 months]
- +4 more secondary outcomes
Study Arms (2)
Laparoscopic Nissen Fundoplication (LNF)
ACTIVE COMPARATORControl
Combo Transoral Incisionless Fundoplication (CTIF)
ACTIVE COMPARATORTreatment
Interventions
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
Eligibility Criteria
You may qualify if:
- 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:
- Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- EndoGastric Solutionscollaborator
- University of California, Irvinecollaborator
- Fox Valley Surgical Associatescollaborator
- University of Southern Californiacollaborator
- The University of Texas Health Science Center, Houstoncollaborator
- University of Texas at Austincollaborator
- Institute of Esophageal and Reflux Surgerycollaborator
Study Sites (7)
University of California Irvine
Irvine, California, 92697, United States
University of Southern California
Los Angeles, California, 90033, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 880113, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
The University of Texas at Austin
Austin, Texas, 78712, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Fox Valley Surgical
Appleton, Wisconsin, 54911, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking 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.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2021
First Posted
March 12, 2021
Study Start
January 26, 2021
Primary Completion
July 31, 2025
Study Completion (Estimated)
January 1, 2030
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Health information may be collected from: Past, present and future medical records. Research procedures, including research office visits, tests, interviews and questionnaires. Health information will be used and/or given to others to: Do the research. Report the results. See if the research was conducted following the approved study plan, and applicable rules and regulations. Health information may be used and shared with: Mayo Clinic research staff involved in this study or clinical care. Researchers involved in this study at other institutions. The sponsor of this study and the people or groups hired by the sponsor to help perform this research. The Mayo Clinic Institutional Review Board that oversees the research. Federal and State agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies) or government agencies in other countries that oversee or review research.