Department of Surgery, St Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.
Department of Surgery, Isala Clinics, Zwolle, The Netherlands.
Br J Surg. 2017 Jun;104(7):843-851. doi: 10.1002/bjs.10500. Epub 2017 Mar 13.
BACKGROUND: Partial fundoplications provide similar reflux control with fewer post-fundoplication symptoms compared with Nissen fundoplication for gastro-oesophageal reflux disease (GORD). The best choice of procedure for partial fundoplication remains unclear. The aim of this study was to compare the outcome of two different types of partial fundoplication for GORD. METHODS: A double-blind RCT was conducted between 2012 and 2015 in two hospitals specializing in antireflux surgery. Patients were randomized to undergo either a laparoscopic 270° posterior fundoplication (Toupet) or a laparoscopic 180° anterior fundoplication. The primary outcome was postoperative dysphagia at 12 months, measured by the Dakkak score. Subjective outcome was analysed at 1, 3, 6 and 12 months after surgery. Objective reflux control was assessed before and 6 months after surgery. RESULTS: Ninety-four patients were randomized to laparoscopic Toupet or laparoscopic 180° anterior fundoplication (47 in each group). At 12 months, 85 patients (90 per cent) were available for follow-up. Objective scores were available for 76 (81 per cent). Postoperative Dakkak dysphagia score at 12 months was similar in the two groups (mean 5·9 for Toupet versus 6·4 for anterior fundoplication; P = 0·773). Subjective outcome at 12 months demonstrated no significant differences in control of reflux or post-fundoplication symptoms. Overall satisfaction and willingness to undergo surgery did not differ between the groups. Postoperative endoscopy and 24-h pH monitoring showed no significant differences in mean oesophageal acid exposure time or recurrent pathological oesophageal acid exposure. CONCLUSION: Both types of partial fundoplication provided similar control of GORD at 12 months, with no difference in post-fundoplication symptoms. Registration number: NTR5702 (www.trialregister.nl).
背景:与 Nissen 胃底折叠术相比,部分胃底折叠术在治疗胃食管反流病(GORD)时可提供相似的反流控制效果,且术后并发症更少。但对于部分胃底折叠术,哪种术式最佳仍不明确。本研究旨在比较两种不同类型的部分胃底折叠术治疗 GORD 的效果。
方法:本研究为 2012 年至 2015 年在两家专门从事抗反流手术的医院开展的一项双盲 RCT。患者被随机分为腹腔镜 270°后胃底折叠术(Toupet)组或腹腔镜 180°前胃底折叠术组。术后 12 个月时,采用 Dakkak 评分评估术后吞咽困难,为主要结局。术后 1、3、6 和 12 个月时,分析主观结局。术前和术后 6 个月时评估客观反流控制情况。
结果:94 例患者被随机分为腹腔镜 Toupet 组或腹腔镜 180°前胃底折叠术组(每组 47 例)。术后 12 个月时,85 例(90%)患者可进行随访。76 例(81%)患者可提供客观评分。两组患者术后 12 个月的 Dakkak 吞咽困难评分相似(Toupet 组为 5.9 分,前胃底折叠术组为 6.4 分;P=0.773)。术后 12 个月时,两组患者的反流控制和术后胃底折叠术相关症状均无显著差异。总体满意度和再次手术意愿在两组间无差异。术后内镜检查和 24 h pH 监测显示,两组患者的食管酸暴露时间和复发性病理性食管酸暴露的平均时间均无显著差异。
结论:两种类型的部分胃底折叠术在术后 12 个月时均能提供相似的 GORD 控制效果,且术后并发症无差异。注册号:NTR5702(www.trialregister.nl)。
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