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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2030-01-31

Brief Summary

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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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Detailed Description

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Conditions

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GERD Hiatal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Laparoscopic Nissen Fundoplication (LNF)

Control

Group Type ACTIVE_COMPARATOR

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

Intervention Type PROCEDURE

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

Combo Transoral Incisionless Fundoplication (CTIF)

Treatment

Group Type ACTIVE_COMPARATOR

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

Intervention Type PROCEDURE

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

Interventions

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LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

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

Intervention Type PROCEDURE

Other Intervention Names

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LAPAROSCOPIC NISSEN FUNDOPLICATION

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No