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

GERD Clinical Trial

— CTIF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795934
• Other study ID #: 19-005226
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• GERD
• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Fox Valley Surgical	Appleton	Wisconsin
United States	The University of Texas at Austin	Austin	Texas
United States	Institute of Esophageal and Reflux Surgery	Englewood	Colorado
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of California Irvine	Irvine	California
United States	University of Southern California	Los Angeles	California
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (8)

Lead Sponsor	Collaborator
Mayo Clinic	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in AET	Upper Endoscopy with 72 Hrs BravoPH Case Report Form	[Time Frame: 6 months]
Secondary	Incidence of bloating	Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form	[Time Frame: 6 months]
Secondary	Incidence of dysphagia	Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form	[Time Frame: 6 months]
Secondary	Change in distensibility index of GE junction	Endoflip (optional) Case Report Form	[Time Frame: 6 months]
Secondary	Cessation of Proton Pump Inhibitor (PPI) use	PPI Use Questionnaire Case Report Form	[Time Frame: 6 months]
Secondary	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]
Secondary	Recurrence of hiatal hernia	Upper Endoscopy with 72 Hrs BravoPH Case Report Form	[Time Frame: 6 months]
Secondary	Hill grade of GE junction	Upper Endoscopy with 72 Hrs BravoPH Case Report Form	[Time Frame: 6 months]
Secondary	Adverse events rate	Adverse Event Case Report Form	[Time Frame: 6 months]

External Links

•   Mayo Clinic Clinical Trials