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NCT Number: NCT04795934

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

Procedure

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION

Other names: LAPAROSCOPIC NISSEN FUNDOPLICATION

Primary outcomes

  1. Mean difference in HRQL score ≤ 15%

    Time frame: 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 outcomes

  1. Change in AET

    Time frame: [Time Frame: 6 months]

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

  2. Incidence of bloating

    Time frame: [Time Frame: 6 months]

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

  3. Incidence of dysphagia

    Time frame: [Time Frame: 6 months]

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

  4. Change in distensibility index of GE junction

    Time frame: [Time Frame: 6 months]

    Endoflip (optional) Case Report Form

  5. Cessation of Proton Pump Inhibitor (PPI) use

    Time frame: [Time Frame: 6 months]

    PPI Use Questionnaire Case Report Form

  6. Healing of esophagitis

    Time frame: [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: [Time Frame: 6 months]

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

  8. Hill grade of GE junction

    Time frame: [Time Frame: 6 months]

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

  9. Adverse events rate

    Time frame: [Time Frame: 6 months]

    Adverse Event Case Report Form

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study 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

Acronym: CTIF

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Mar 12, 2021
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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