(Santa Ana, CA)-Coastal Communities Hospital announces that Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute and the most prominent journal in the field of gastrointestinal disease, has published landmark data from the first-ever blinded, randomized, sham- and placebo-controlled clinical study of the Transoral Incisionless Fundoplication (TIF®) procedure.
Of the 87 patients who were randomly assigned to the group that underwent the TIF procedure and then received an ongoing course of placebo medication, 67% reported elimination of troublesome regurgitation. Meanwhile, of the 42 patients who were randomized to undergo sham surgery and then continued to take optimized dose of proton pump inhibitor (PPI) regiment, just 45% reported elimination of the same symptom.
“Consistent with the Montreal definition, the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) study enrolled patients with troublesome regurgitation and objectively confirmed gastroesophageal reflux disease (GERD). This is the first ever randomized blinded trial to focus exclusively on regurgitation,” said Coastal Communities Hospital Dr. Yasser Salem. “The results of this study suggests that the TIF procedure provides an attractive option to manage troublesome GERD symptoms, especially considering there are virtually no side-effects after the TIF procedure. I’m thrilled with outcome of this study and it is truly an honor to be featured in Gastroenterology for our accomplishments,” continued Dr. Salem.
Note: Eight participating academic and community centers screened 696 patients of which 129 were enrolled into the RESPECT study. The investigators, consisting of 15 general surgeons and a gastroenterologist, will follow the patients for 12 months. Additional information about the RESPECT study can be found at www.clinicaltrials.gov. Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up occurred at two, 12 and 26 weeks. At the six-month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.
