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

Not Applicable

Active, not recruiting

• Conditions: Hiatal Hernia; GERD
• Interventions: Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

• Registration Number: NCT04795934
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 142

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Nissen Fundoplication (LNF)	LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION	Control
Combo Transoral Incisionless Fundoplication (CTIF)	LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION	Treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Incidence of bloating	[Time Frame: 6 months]	Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form
Adverse events rate	[Time Frame: 6 months]	Adverse Event Case Report Form
Incidence of dysphagia	[Time Frame: 6 months]	Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form
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
Change in AET	[Time Frame: 6 months]	Upper Endoscopy with 72 Hrs BravoPH Case Report Form
Change in distensibility index of GE junction	[Time Frame: 6 months]	Endoflip (optional) Case Report Form

Trial Locations

Locations (7)

University of California Irvine; 🇺🇸 Irvine, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Institute of Esophageal and Reflux Surgery; 🇺🇸 Englewood, Colorado, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Fox Valley Surgical; 🇺🇸 Appleton, Wisconsin, United States