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腹腔镜下 Nissen 或 180°前部分胃底折叠术治疗胃食管反流病 12 年后的长期症状控制:一项随机临床试验。

Long-term symptom control of gastro-oesophageal reflux disease 12 years after laparoscopic Nissen or 180° anterior partial fundoplication in a randomized clinical trial.

机构信息

Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.

Department of Surgery, Prince of Wales Hospital, Randwick, Australia.

出版信息

Br J Surg. 2017 Jun;104(7):852-856. doi: 10.1002/bjs.10473. Epub 2017 Feb 3.

Abstract

BACKGROUND

Laparoscopic 180° anterior fundoplication has been shown to achieve similar reflux control to Nissen fundoplication, with fewer side-effects, up to 5 years. However, there is a paucity of long-term follow-up data on this technique and antireflux surgery in general. This study reports 12-year outcomes of a double-blind RCT comparing laparoscopic Nissen versus 180° laparoscopic anterior fundoplication for gastro-oesophageal reflux disease (GORD).

METHODS

Patients with proven GORD were randomized to laparoscopic Nissen or 180° anterior fundoplication. The 12-year outcome measures included reflux control, dysphagia, gas-related symptoms and patient satisfaction. Measures included scores on a visual analogue scale, a validated Dakkak score for dysphagia and Visick scores.

RESULTS

Of the initial 163 patients randomized (Nissen 84, anterior 79), 90 (55·2 per cent) completed 12-year follow-up (Nissen 52, anterior 38). There were no differences in heartburn, dysphagia, gas-related symptoms, patient satisfaction or surgical reintervention rate. Use of acid-suppressing drugs was less common after Nissen than after 180° anterior fundoplication: four of 52 (8 per cent) and 11 of 38 (29 per cent) respectively (P = 0·008). The proportion of patients with absent or only mild symptoms was slightly higher after Nissen fundoplication: 45 of 50 (90 per cent) versus 28 of 38 (74 per cent) (P = 0·044).

CONCLUSION

The two surgical procedures provided similar control of heartburn and post-fundoplication symptoms, with similar patient satisfaction and reoperation rates on long-term follow-up.

摘要

背景

腹腔镜 180° 前胃底折叠术已被证明可与 Nissen 胃底折叠术达到相似的反流控制效果,且副作用更少,长达 5 年。然而,关于这种技术和抗反流手术的长期随访数据很少。本研究报告了一项比较腹腔镜 Nissen 与腹腔镜 180° 前胃底折叠术治疗胃食管反流病(GORD)的双盲 RCT 的 12 年结果。

方法

经证实患有 GORD 的患者被随机分为腹腔镜 Nissen 或 180° 腹腔镜前胃底折叠术组。12 年的随访结果包括反流控制、吞咽困难、气体相关症状和患者满意度。测量包括视觉模拟评分、吞咽困难的 Dakkak 评分和 Visick 评分。

结果

在最初随机分配的 163 例患者中(Nissen 84 例,前胃底折叠术 79 例),90 例(55.2%)完成了 12 年的随访(Nissen 52 例,前胃底折叠术 38 例)。两组在烧心、吞咽困难、气体相关症状、患者满意度或手术再干预率方面均无差异。Nissen 组比 180° 前胃底折叠术组使用抑酸药物的情况更少:52 例中有 4 例(8%),38 例中有 11 例(29%)(P=0.008)。Nissen 胃底折叠术组中无症状或仅有轻度症状的患者比例略高:50 例中有 45 例(90%),38 例中有 28 例(74%)(P=0.044)。

结论

两种手术方法在长期随访中均能提供相似的烧心和术后症状控制,患者满意度和再手术率相似。

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