Abstract
Louis, MO; Mayo Clin, Rochester, MN; Indiana Univ, Indianapolis, IN; Park Plaza Med Ctr, Houston, TX; Dartmouth Hitchcock Med Ctr, Lebanon, NH; Colorado Univ, Denver, CO; Emory Univ, Atlanta, GA; C R BAAD, Inc, IN. Introduction: A totally transoral outpatient procedure for the treatment of gastroesophageal reflux disease (GERD) would be appealing to physicians and patients. Methods: A multicenter trial was initiated for 64 patients suffering from symptomatic GERD. Inclusion criteria were 3 or more heartburn episodes per week while off medication, dependency on antisecretory medicine and documented acid reflux by pH monitoring (pH 40kg/ meter2) previous esophageal surgery and hiatus hernia >2 cm. Patients underwent esophageal manometry, endoscopy, 24 hour pH monitoring and completed a MOS SF-36 quality of life (QOL) questionnaire and symptom severity scoring. Patients were then randomized to a linear or circumferential plication configuration group. After the endoscopic valvuloplasty patients repeated the (QOL) questionnaire and underwent endoscopy, manometry and 24 hour pH monitoring at 3 months and 6 months. All adverse procedural events were recorded. Symptom change scores were analyzed with the Wilcoxon signed-rank test. Procedural success was defined as patients that were symptom free with fewer than 4 doses of acid reduction medicine per month. Results: Sixty-two percent of patients experienced success at 3 months. Six month data are pending. Mean three month symptom change scores demonstrated procedural efficacy. GROUP MEAN VALUES Baseline, 3 months p (sign rank test): Heartburn score 62.5, 16.6, 0.0001, Heartburn frequency 2.8, 1.4, 0.0001, Heartburn severity 22.8, 9.2, 0.0001, Regurgitation 1.8, 0.6, 0.0001 respectively, Of those patients suffering with regurgitation (80%), more than one half (55%) reported they no longer suffer from this problem. Only patients with preprocedure acid reflux time >10% had an improvement in % time pH
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