• Lancet · Jan 2009

    Randomized Controlled Trial Multicenter Study

    Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial.

    • Nigel J Hall, Maurizio Pacilli, Simon Eaton, Kim Reblock, Barbara A Gaines, Aimee Pastor, Jacob C Langer, Antti I Koivusalo, Mikko P Pakarinen, Lutz Stroedter, Stefan Beyerlein, Munther Haddad, Simon Clarke, Henri Ford, and Agostino Pierro.
    • UCL Institute of Child Health and Great Ormond Street Hospital, London, UK.
    • Lancet. 2009 Jan 31;373(9661):390-8.

    BackgroundA 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.MethodsWe 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.FindingsTime 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.InterpretationBoth 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.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…