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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04795934
Collaborator
EndoGastric Solutions (Industry), University of California, Irvine (Other), Fox Valley Surgical Associates (Other), University of Southern California (Other), The University of Texas Health Science Center, Houston (Other), University of Texas at Austin (Other), Institute of Esophageal and Reflux Surgery (Other)
142
Enrollment
7
Locations
2
Arms
70.1
Anticipated Duration (Months)
20.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
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.
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Jan 26, 2021
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Change in AET [[Time Frame: 6 months]]

      Upper Endoscopy with 72 Hrs BravoPH Case Report Form

    2. Incidence of bloating [[Time Frame: 6 months]]

      Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form

    3. Incidence of dysphagia [[Time Frame: 6 months]]

      Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form

    4. Change in distensibility index of GE junction [[Time Frame: 6 months]]

      Endoflip (optional) Case Report Form

    5. Cessation of Proton Pump Inhibitor (PPI) use [[Time Frame: 6 months]]

      PPI Use Questionnaire Case Report Form

    6. 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

    7. Recurrence of hiatal hernia [[Time Frame: 6 months]]

      Upper Endoscopy with 72 Hrs BravoPH Case Report Form

    8. Hill grade of GE junction [[Time Frame: 6 months]]

      Upper Endoscopy with 72 Hrs BravoPH Case Report Form

    9. Adverse events rate [[Time Frame: 6 months]]

      Adverse Event Case Report Form

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    1. Commitment to long-term study

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California Irvine Irvine California United States 92697
    2 University of Southern California Los Angeles California United States 90033
    3 Institute of Esophageal and Reflux Surgery Englewood Colorado United States 880113
    4 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    5 The University of Texas at Austin Austin Texas United States 78712
    6 University of Texas Health Science Center at Houston Houston Texas United States 77030
    7 Fox Valley Surgical Appleton Wisconsin United States 54911

    Sponsors and Collaborators

    • 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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Barham K. Abu Dayyeh, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04795934
    Other Study ID Numbers:
    • 19-005226
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Hernia
    Hernia, Hiatal

    Study Results

    No Results Posted as of Jun 23, 2022