Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial
Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial
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DOI：
10.1016/s0140-6736(09)60006-4
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发表时间：
2009-01-01
期刊：
影响因子：
168.9
通讯作者：
Pierro, Agostino
中科院分区：
文献类型：
--
作者：
Hall, Nigel J.;Pacilli, Maurizio;Pierro, Agostino
背景腹腔镜下幽门环肌切开术治疗婴幼儿幽门狭窄已得到广泛应用，但其有效性尚未得到证实。我们的目的是比较开放或腹腔镜pyloromyotomy治疗pyloric stenosis.Methods后的结果，我们做了一个多中心的国际，双盲，随机，对照试验，2004年6月和2007年5月之间，在6个三级儿科手术中心。将180名婴儿随机分配至开放式（n=93）或腹腔镜幽门环肌切开术（n=87），最小化年龄、体重、出生时胎龄、首次出现碳酸氢盐、喂养类型、术前症状持续时间和试验中心。诊断为幽门狭窄的婴儿是合格的。主要结果是达到完全肠内喂养的时间和术后恢复的持续时间。我们的目标是招募200名婴儿（每组100名）;然而，数据监测和伦理委员会建议在完全招募之前停止试验，因为在中期分析时，一组婴儿的治疗获益显著。参与者，父母和护理人员不知道治疗。采用回归分析在意向治疗的基础上对数据进行分析。该试验在ClinicalTrials.gov注册，编号NCT 00144924。结果开放式幽门肌切开术组实现完全肠内喂养的时间（中位数[IQR]）为23.9 h（16.0-41.0），而开放式幽门肌切开术组为18.5 h（12.3-24. 0; p=0。002)腹腔镜组;术后住院时间为43.8 h（25.3-55. 6)与33.6小时相比（22.9-48.1; p=0.027）。术后呕吐，术中和术后并发症是相似的两个groups.Interpretation开放式和腹腔镜幽门环肌切开术是安全的程序幽门狭窄的管理。然而，腹腔镜手术优于开放性幽门环肌切开术，我们建议在有合适腹腔镜经验的中心使用。
Background A laparoscopic approach to pyloromyotomy for infantile pyloric stenosis has gained popularity but its effectiveness remains unproven. We aimed to compare outcomes after open or laparoscopic pyloromyotomy for the treatment of pyloric stenosis.Methods We did a multicentre international, double-blind, randomised, controlled trial between June, 2004, and May, 2007, across six tertiary paediatric surgical centres. 180 infants were randomly assigned to open (n=93) or laparoscopic pyloromyotomy (n=87) with minimisation for age, weight, gestational age at birth, bicarbonate at initial presentation, feeding type, preoperative duration of symptoms, and trial Centre. Infants with a diagnosis of pyloric stenosis were eligible. Primary outcomes were time to achieve full enteral feed and duration of postoperative recovery. We aimed to recruit 200 infants (100 per group); however, the data monitoring and ethics committee recommended halting the trial before full recruitment because of significant treatment benefit in one group at interim analysis. Participants, parents, and nursing staff were unaware of treatment. Data were analysed on an intention-to-treat basis with regression analysis. The trial is registered with ClinicalTrials.gov, number NCT00144924.Findings Time to achieve full enteral feeding in the open pyloromyotomy group was (median [IQR]) 23.9 h (16.0-41.0) versus 18.5 h (12.3-24. 0; p=0 . 002) in the laparoscopic group; postoperative length of stay was 43.8 h (25.3-55. 6) versus 33.6 h (22.9-48.1; p=0.027). Postoperative vomiting, and intra-operative and postoperative complications were similar between the two groups.Interpretation Both open and laparoscopic pyloromyotomy are safe procedures for the management of pyloric stenosis. However, laparoscopy has advantages over open pyloromyotomy, and we recommend its use in centres with suitable laparoscopic experience.Funding Sir Arthur Halley Stewart Trust.