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Randomized Controlled Trial Multicenter Study Comparative Study
Five-year follow-up of a multicenter, double-blind randomized clinical trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication.
- Rajwinder S Nijjar, David I Watson, Glyn G Jamieson, Stephen Archer, Justin R Bessell, Michael Booth, Richard Cade, Graham L Cullingford, Peter G Devitt, David R Fletcher, James Hurley, George Kiroff, Ian J G Martin, Leslie K Nathanson, John A Windsor, and International Society for the Diseases of the Esophagus-Australasian Section.
- University of Adelaide, Adelaide, South Australia.
- Arch Surg. 2010 Jun 1;145(6):552-7.
HypothesisLaparoscopic 90 degrees anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication.DesignA multicenter, prospective, double-blind randomized clinical trial with a minimum of 5 years' follow-up.SettingNine university teaching hospitals in 6 major cities throughout Australia and New Zealand.ParticipantsOne 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).InterventionsLaparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication.Main Outcome MeasuresBlinded 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.ResultsNinety-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.ConclusionsLaparoscopic 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 RegistrationAustralian New Zealand Clinical Trials Register Identifier: ACTRN12607000298415.
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