Nijjar Rajwinder S, Watson David I, Jamieson Glyn G, Archer Stephen, Bessell Justin R, Booth Michael, Cade Richard, Cullingford Graham L, Devitt Peter G, Fletcher David R, Hurley James, Kiroff George, Martin Ian J G, Nathanson Leslie K, Windsor John A
University of Adelaide, Adelaide, South Australia.
Arch Surg. 2010 Jun;145(6):552-7. doi: 10.1001/archsurg.2010.81.
Laparoscopic 90 degrees anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication.
A multicenter, prospective, double-blind randomized clinical trial with a minimum of 5 years' follow-up.
Nine university teaching hospitals in 6 major cities throughout Australia and New Zealand.
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).
Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication.
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.
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.
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.
Australian New Zealand Clinical Trials Register Identifier: ACTRN12607000298415.
腹腔镜90度前位部分胃底折叠术治疗胃食管反流病的效果与腹腔镜nissen胃底折叠术相当。
一项多中心、前瞻性、双盲随机临床试验，至少随访5年。
澳大利亚和新西兰6个主要城市的9所大学教学医院。
112例行初次抗反流手术的患者被随机分为接受腹腔镜nissen胃底折叠术（52例患者）或前位90度部分胃底折叠术（60例患者）。
腹腔镜nissen胃底折叠术并切断胃短血管或腹腔镜前位90度部分胃底折叠术。
在随访1年和5年时对烧心、吞咽困难、气体相关症状的临床结局以及对手术结局的满意度进行盲法评估。使用0至10的模拟量表评估症状严重程度。
97例患者接受了5年随访。另外3例在随访期间死亡，4例拒绝随访，8例失访；89%的患者完成了5年随访。在5年随访时，前位胃底折叠术患者烧心的平均模拟评分为2.2，nissen胃底折叠术患者为0.9（P = 0.003）。两组吞咽困难评分无显著差异。前位胃底折叠术后结局满意度的平均评分为7.1，nissen胃底折叠术后为8.1（P = 0.18）。nissen胃底折叠术后88%的患者报告结局良好或极佳，前位胃底折叠术后为77%。
腹腔镜nissen胃底折叠术和前位90度部分胃底折叠术在5年随访时患者满意度水平相似，不良反应情况也相似。然而，在5年随访时，腹腔镜nissen胃底折叠术对反流症状的控制更优。
澳大利亚新西兰临床试验注册标识符：ACTRN12607000298415。
