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.
Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure). Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
University Hospitals Leuven
Leuven, Belgium
University of Nantes Hospital
Nantes, France
Karolinska University, Ersta Hospital
Stockholm, Sweden
Karolinska University, Huddinge Hospital
Stockholm, Sweden
Proportion of patients in clinical remission
Fifty nine per cent of patients remained in clinical remission
Time frame: at 6 month follow-up
Reduction in symptoms
GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004.
Time frame: at 6 moths follow-up
Normalized esophageal acid exposure
Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure.
Time frame: at 6 months follow-up
Healed reflux esophagitis
In 80% of patients healing of esophagitis was observed
Time frame: at 6 months follow-up
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