Clinical trial NCT04795934: Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: GERD
Hiatal Hernia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: EndoGastric Solutions
name: University of California, Irvine
name: Fox Valley Surgical Associates
name: University of Southern California
name: The University of Texas Health Science Center, Houston
name: University of Texas at Austin
name: Institute of Esophageal and Reflux Surgery
First posted: 2021-03-12
Enrollment: 142
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean difference in HRQL score ≤ 15%
timeFrame: 6 months
Secondary outcomes:
measure: Change in AET
timeFrame: [Time Frame: 6 months]
measure: Incidence of bloating
timeFrame: [Time Frame: 6 months]
measure: Incidence of dysphagia
timeFrame: [Time Frame: 6 months]
measure: Change in distensibility index of GE junction
timeFrame: [Time Frame: 6 months]
measure: Cessation of Proton Pump Inhibitor (PPI) use
timeFrame: [Time Frame: 6 months]
measure: Healing of esophagitis
timeFrame: [Time Frame: 6 months]
measure: Recurrence of hiatal hernia
timeFrame: [Time Frame: 6 months]
measure: Hill grade of GE junction
timeFrame: [Time Frame: 6 months]
measure: Adverse events rate
timeFrame: [Time Frame: 6 months]
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Englewood
country: United States
facility: Institute of Esophageal and Reflux Surgery
state: Colorado
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Appleton
country: United States
facility: Fox Valley Surgical
state: Wisconsin
Study officials:
References: