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 degrees 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' follow-up. 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 degrees partial fundoplication (60 patients). INTERVENTIONS: Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees 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 degrees 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register Identifier: ACTRN12607000298415.