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Published on: June 17, 2018
Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised
Nigel J Hall1, Maurizio Pacilli, Simon Eaton
1UCL Institute of Child Health and Great Ormond Street Hospital, London, UK.
Insights
Laparoscopic pyloromyotomy for infantile pyloric stenosis leads to faster feeding and shorter recovery than open surgery. Both methods are safe, but laparoscopy offers advantages for experienced centers.
Area of Science:
- Pediatric Surgery
- Minimally Invasive Surgery
- Gastrointestinal Surgery
Background:
- Infantile pyloric stenosis is a common condition requiring surgical intervention.
- Laparoscopic pyloromyotomy is increasingly used, but its efficacy compared to open surgery is not well-established.
- This study aimed to compare outcomes of open versus laparoscopic pyloromyotomy.
Purpose of the Study:
- To compare the effectiveness and safety of laparoscopic pyloromyotomy versus open pyloromyotomy in infants with pyloric stenosis.
- To evaluate key postoperative recovery metrics including time to full enteral feeding and length of hospital stay.
Main Methods:
- A multicenter, international, double-blind, randomized controlled trial involving 180 infants.
- Infants were randomized to either open (n=93) or laparoscopic pyloromyotomy (n=87).
- Primary outcomes were time to full enteral feeding and duration of postoperative recovery; trial halted early due to observed benefit.
Main Results:
- Laparoscopic pyloromyotomy resulted in significantly faster achievement of full enteral feeding (18.5h vs 23.9h, p=0.002).
- Postoperative length of stay was shorter for the laparoscopic group (33.6h vs 43.8h, p=0.027).
- Rates of vomiting and complications were comparable between open and laparoscopic approaches.
Conclusions:
- Both open and laparoscopic pyloromyotomy are safe and effective for treating infantile pyloric stenosis.
- Laparoscopic pyloromyotomy demonstrates superior outcomes regarding feeding and recovery time.
- The study recommends the adoption of laparoscopic pyloromyotomy in centers with appropriate surgical expertise.
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.
