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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hiatal Hernia; GERD
• Intervention / Treatment: Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • University of California Irvine
      • Contact: Kenneth J Chang, MD; Phone Number: 714-456-6187; Email: kchang@hs.uci.edu
      • Contact: Figueroa Cesar; Phone Number: 714-456-7539; Email: figuerc1@hs.uci.edu
      • Sub-Investigator: Ninh T Nguyen, MD
      • Principal Investigator: Kenneth J Chang, MD
    • Los Angeles, California, United States, 90033
      • Not yet recruiting
      • University of Southern California
      • Contact: John C Lipham, MD; Phone Number: 323-442-9067; Email: John.Lipham@med.usc.edu
      • Contact: Stephanie Varela; Phone Number: 213-220-5885; Email: stephanie.varela@med.usc.edu
      • Principal Investigator: John C Lipham, MD
  • Colorado
    • Englewood, Colorado, United States, 880113
      • Recruiting
      • Institute of Esophageal and Reflux Surgery
      • Contact: Reginald Bell, M.D.; Phone Number: 303-788-7700; Email: reg@iersurgery.com
      • Contact: Rachel Heidrick; Phone Number: 303-788-1636; Email: rachel@iersurgery.com
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Elizabeth A Lemke, MPH; Phone Number: 507-266-3317; Email: Lemke.Elizabeth@mayo.edu
      • Contact: Samantha Thorson; Phone Number: 507-255-4803; Email: Thorson.Samantha@Mayo.edu
      • Principal Investigator: Barham K Abu Dayyeh, MD
      • Sub-Investigator: Reisenauer S Janani, MD
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • The University of Texas at Austin
      • Contact: Rose "RJ" Goodrich; Phone Number: 512-495-2112; Email: rose.jonesgoodrich@austin.utexas.edu
      • Principal Investigator: F. P. "Tripp" Buckley III, MD, FACS
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center at Houston
      • Contact: Erik B Wilson, MD; Phone Number: 713-486-1338; Email: Erik.B.Wilson@uth.tmc.edu
      • Contact: Connie Pollard; Email: Connie.Pollard@uth.tmc.edu
      • Principal Investigator: Erik B Wilson, MD
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • Recruiting
      • Fox Valley Surgical
      • Contact: Peter G Janu; Phone Number: 920-277-3015; Email: Peter.Janu@fvsawi.com
      • Contact: Wendy; Email: pjanu@new.rr.com
      • Principal Investigator: Peter G Janu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: The University of Texas Health Science Center, Houston; University of Southern California; University of California, Irvine; University of Texas at Austin; EndoGastric Solutions; Fox Valley Surgical Associates; Institute of Esophageal and Reflux Surgery

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: 19-005226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No