Bell RC, Barnes WE, Carter BJ, Sewell RW. Mavrelis PG, Ihde GM, Hoddinott KM, Fox MA, Freeman KD, Gunsberger T, Hausmann MG, Dargis D, Gill BD, Wilson E, Trad KS
Am Surg. 2014 Nov; 80(11):1093-1105.
The aim of this study was to assess prospectively 2-year outcomes of transoral incisionless fundoplication (TIF) in a multicenter setting.
A 14 center U.S. registry was designed to evaluate the effects of the TIF 2.0 procedure on chronic gastroesophageal reflux disease (GERD) in over 100 patients. Primary outcome was symptom assessment. Secondary outcomes were proton pump inhibitor (PPI) use, degree of esophagitis, safety and changes in esophageal acid exposure.
One hundred twenty-seven patients underwent TIF between January 2010 and April 2011, 19 (15%) of which were lost to follow-up. Eight patients undergoing revisional surgery were included, as failures, in the 108 remaining patients. No serious adverse events were reported.
GERD Health-related Quality of Life and regurgitation scores improved by ≥ 50% in 63 of 96 (66%) and 62 of 88 (70%) of patients who had elevated preoperative scores. The Reflux Symptom Index score normalized in 53 of 82 (65%) of patients. Daily PPI use decreased from 91% to 29%. In patients amenable to postoperative testing, esophagitis healed in 12 of 16 (75%) and esophageal acid exposure normalized in 8 of 14 (57%). TIF safely achieved sustained symptomatic control over a 2-year period in two-thirds of patients with a virtual absence of de novo side effects.
Link to abstract on PubMed: Bell RC, et al; Am Surg. 2014 Nov;80(11):1093-1105