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LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR WITH TRANSORAL INCISIONLESS FUNDOPLICATION IN GERD

Kenneth Chang


A Study On:

  • Other

Status:

  • Open

Eligibility

GERD
Hiatal Hernia
22 Years to 80 Years (Adult, Older Adult)

Interested in joining this trial?

Official Title

MULTICENTER SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS REQUIRING HIATAL HERNIA REPAIR

Details

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.


Eligibility

You can join if...

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.

  1. Commitment to long-term study
  2. 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

Get in touch with our study team