Five year follow-up of a multicentre double blind randomized clinicial trial of laparoscopic Nissen vs. anterior 90o partial fundoplication.

Rajwinder Najjar, David Watson, Glyn Jamieson, S Archer, Justin Bessell, Michael Booth, R Cade, G Cullingford, P Devitt, David Fletcher, J Hurley, G Kiroff, Ian Martin, L Nathanson, John Windsor

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    Abstract

    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 satisfactionwas 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. Trial Registration: Australian New Zealand Clinical Trials Register Identifier:

    Original languageEnglish
    Pages (from-to)552-557
    Number of pages6
    JournalArchives of Surgery
    Volume145
    Issue number6
    DOIs
    Publication statusPublished - 2010

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    Najjar, R., Watson, D., Jamieson, G., Archer, S., Bessell, J., Booth, M., Cade, R., Cullingford, G., Devitt, P., Fletcher, D., Hurley, J., Kiroff, G., Martin, I., Nathanson, L., & Windsor, J. (2010). Five year follow-up of a multicentre double blind randomized clinicial trial of laparoscopic Nissen vs. anterior 90o partial fundoplication. Archives of Surgery, 145(6), 552-557. https://doi.org/10.1001/archsurg.2010.81