Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux … (NCT01110811) | Clinical Trial Compass
CompletedNot Applicable
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
Belgium, France, Sweden60 participantsStarted 2010-04
Plain-language summary
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-80 years
* On daily PPIs for \> 6 months
* Documented PPI dependency
* Persistent GERD symptoms without PPI therapy during the titration phase of the study
* Evidence of two or more of the following while off PPI therapy (\> 10 days):
* Erosive esophagitis (Los Angeles grade A-C)
* Abnormal ambulatory pH study
* Moderate to severe GERD symptoms
* Normal or near normal esophageal motility (by manometry)
* Patient willing to cooperate with post-operative dietary recommendations and assessment tests
* Signed informed consent
Exclusion Criteria:
* BMI \> 35
* Hiatal hernia \> 3 cm
* Esophagitis LA grade D
* Esophageal ulcer
* Esophageal stricture
* Barretts esophagus (Prague: C\>1, M\>2)
* Esophageal motility disorder
* Severe gastric paralysis
* Pregnancy or plans for pregnancy in the next 12 months
* Immunosuppression
* ASA \> 2
* Portal hypertension and/or varices
* History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
* Active gastro-duodenal ulcer disease
* Gastric outlet obstruction or stenosis
* Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
* Coagulation disorders