Full-thickness gastroplication for the treatment of gastroesophageal reflux disease: short-term results of a feasibility clinical trial.

This was a prospective study that evaluates subjective and objective patient parameters 3 months after full-thickness gastroplication. Forty-one patients with documented gastroesophageal reflux disease and persistent symptoms despite medical treatment, without radiologic visible hiatal hernia, were enrolled in the study and underwent endoscopic full-thickness gastroplication with one or more plicator implants. Evaluation of Gastrointestinal Quality of Life Index, symptoms typically related to reflux, gas bloat, and bowel dysfunction and esophageal manometry, and impedance-pH monitoring were performed at baseline and 3 months after the procedure. The mean Gastrointestinal Quality of Life Index score, and general and reflux-specific scores improved significantly (P<0.01), and gas bloat-specific symptom scores and bowel dysfunction-specific symptom scores were reduced (P<0.05) on follow-up. The numbers of total, acid, proximal, upright, and recumbent reflux episodes were all reduced (P<0.01). Manometric data remained almost unchanged. DeMeester score reduced nonsignificantly (P<0.098). 21.6% of the patients were on proton-pump inhibitor medication on a daily basis after the procedure. There was only 1 postprocedure incident (bleeding) that required intervention. In conclusion, endoscopic full-thickness plication is a safe and well-tolerated procedure that significantly improves quality of life and eliminates gastroesophageal reflux disease symptoms in the majority of patients, without side effects seen after laparoscopic fundoplication.