Transoral Incisionless Fundoplication in Post-POEM GERD
Sponsored by Baylor College of Medicine
About this trial
Last updated 2 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Age greater than 18 years old
- Able to sign consent
- Patients must meet standard clinical indications for POEM procedure (all indications) for the initial enrollment
- To undergo TIF: Evidence of GERD/GERD related complications after POEM:
- pathologic acid exposure on pH testing (Deemester score >14.72 or percentage time pH <4 greater than 5.3%) off of PPI (19)
- esophagitis on EGD (grades A to C)
- biopsies showing evidence of reflux esophagitis
Exclusion Criteria
- Adults unable to consent
- Pregnant women - Prisoners
- Delayed gastric emptying
- Code status of DNR/DNI or CMO
- Any patient with moderate to severe esophagitis pre-POEM
- Grade D esophagitis post POEM
- Hiatal hernia >2cm
- PPI use prior to POEM (and if PPI is needed)
- Previous surgery of the stomach
- Known GI malignancy
- Cirrhosis with portal hypertension, varices, or ascites
- Previous anti-reflux surgery
- Patients who choose not to undergo TIF or if insurance will not cover the procedure.