Multicenter, prospective, double-blind, randomized trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication

Abstract

Hypothesis Laparoscopic anterior 90º partial fundoplication for gastroesophageal reflux is associated with a lower incidence of postoperative dysphagia and other adverse effects compared with laparoscopic Nissen fundoplication. Design A multicenter, prospective, double-blind, randomized controlled trial. Setting Nine university teaching hospitals in 6 major cities in Australia and New Zealand. Participants One hundred twelve patients with proven gastroesophageal reflux disease presenting for laparoscopic fundoplication were randomized to undergo either a Nissen (52 patients) or an anterior 90º partial procedure (60 patients). Patients with esophageal motility disorders, patients requiring a concurrent abdominal procedure, and patients who had undergone previous antireflux surgery were excluded from this study. Interventions Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90º partial fundoplication. Main Outcome Measures Independent assessment of dysphagia, heartburn, and overall satisfaction 1, 3, and 6 months after surgery using multiple clinical grading systems. Objective measurement of esophageal manometric parameters, esophageal acid exposure, and endoscopic assessment. Results Postoperative dysphagia, and wind-related adverse effects were less common after a laparoscopic anterior 90º partial fundoplication. Relief of heartburn was better following laparoscopic Nissen fundoplication. Overall satisfaction was better after anterior 90º partial fundoplication. Lower esophageal sphincter pressure, acid exposure, and endoscopy findings were similar for both procedures. Conclusions At the 6-month follow-up, laparoscopic anterior 90º partial fundoplication is followed by fewer adverse effects than laparoscopic Nissen fundoplication with full fundal mobilization, and it achieves a higher rate of satisfaction with the overall outcome. However, this is offset to some extent by a greater likelihood of recurrent gastroesophageal reflux symptoms.