More than 30 peer reviewed studies, including 4 adequately powered randomized, controlled studies, a comprehensive meta-analysis and multiple prospective clinical trials have documented the safety and efficacy of the Stretta procedure. Durable treatment outcomes to at least to 48 months also have been demonstrated in multiple studies, with significant reduction or elimination of medications used to treat the symptoms of GERD, as well as improvement in GERD QOL and symptom scores. Stretta may be recommended as an appropriate therapeutic option for patients with GERD who meet current indications and patient selection criteria and choose endoluminal therapy over laparoscopic fundoplication. Those criteria include:
Adult patients (age >=18) with symptoms of heartburn, regurgitation, or both for >= 6 months who have been partially or completely responsive to antisecretory pharmacologic therapy.
The procedure has not been studied and should not be applied in treating patients with severe esophagitis, hiatus hernias > 2 cm, long segment Barrett esophagus, dysphagia, or those with a history of autoimmune disease, collagen vascular disease, and/or coagulation disorders. Further studies are needed to evaluate the role of Stretta in children if it is to be considered a therapeutic option.
Stretta is considered appropriate therapy for patients being treated for GERD who are 18 years of age or older, who have had symptoms of heartburn, regurgitation, or both for 6 months or more, who have been partially or completely responsive to anti-secretory pharmacologic therapy, and who have declined laparoscopic fundoplication.Quality of Evidence: (++++). GRADE Recommendation: Strong
Post Edited (johnboy85) : 2/18/2013 10:33:40 PM (GMT-7)