Five-year follow-up of a multicenter, double-blind randomized clinical trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication

摘要

Hypothesis: Laparoscopic 90° anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication. Design: A multicenter, prospective, double-blind randomized clinical trial with a minimum of 5 years’ followup. Setting: Nine university teaching hospitals in 6 major cities throughout Australia and New Zealand. Participants: One hundred twelve patients undergoing primary antireflux surgery were randomized to undergo either laparoscopic Nissen fundoplication (52 patients) or anterior 90° partial fundoplication (60 patients). Interventions: Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90° partial fundoplication. Main Outcome Measures: Blinded assessment at 1 and 5 years’ follow-up of clinical outcome for postoperative heartburn, dysphagia, gas-related symptoms, and satisfaction with the surgical outcome. Analog scales ranging from 0 to 10 were used to assess symptom severity. Results: Ninety-seven patients underwent follow-up at 5 years. Three others died during follow-up, 4 refused follow-up, and 8 were lost to follow-up; 89% remained at 5-years’ follow-up. At 5 years’ follow-up, mean analog scores for heartburn were 2.2 for anterior fundoplication vs 0.9 for Nissen fundoplication (P=.003). There were no significant differences between the groups for dysphagia scores. The mean score for outcome satisfaction was 7.1 after anterior fundoplication vs 8.1 after Nissen fundoplication (P=.18). Eighty-eight percent reported a good or excellent outcome following Nissen fundoplication vs 77% following anterior fundoplication. Conclusions: Laparoscopic Nissen and anterior 90° partial fundoplication achieve similar levels of patient satisfaction at 5 years’ follow-up, with similar adverse effect profiles. However, at 5 years’ follow-up, laparoscopic Nissen fundoplication achieves superior control of reflux symptoms.