Elsevier

Journal of Pediatric Surgery

Volume 53, Issue 9, September 2018, Pages 1643-1650
Journal of Pediatric Surgery

Original Article
Surgical practice and outcome in 711 neonates and infants undergoing hernia repair in a large multicenter RCT: Secondary results from the GAS Study,☆☆

https://doi.org/10.1016/j.jpedsurg.2018.01.003Get rights and content

Abstract

Background

The GAS study is an international RCT to evaluate neurodevelopmental outcome comparing general plus regional anesthesia versus regional anesthesia alone in 722 neonates and infants who had inguinal hernia repair up to 60 weeks of postmenstrual age. This paper comprises a secondary descriptive analysis of hernias, aspects of surgery and outcomes.

Methods

The incidence of unilateral and bilateral hernias, side preponderance, predictive factors for bilateral hernias and surgical approaches were collated. Follow-up outcome data were examined at 2 years.

Results

Of 711 eligible patients, there were 679 with hernia data showing that 321 hernias were right-sided, 190 left and 168 bilateral. Male to female ratio was 5:1. Of those with unilateral hernias, 25.8% underwent contralateral exploration and in these cases a patent processus vaginalis was found in 68.9%. Bilateral hernias were more common in younger and female patients. At 2 years there was a recurrence rate of 0.99% and in 2.7% of patients a hernia was evident on the contralateral side (metachrony), and this was unrelated to the anesthesia technique.

Conclusions

Bilateral hernias are associated with lower gestational age at birth and female gender. There was a low incidence of complications and the anesthesia technique did not affect surgical outcome.

Level of evidence

Level 1 evidence from prospective treatment study.

Section snippets

Methods

The protocol for the GAS study has been published by The Lancet http://www.thelancet.com/protocol-reviews/09PRT9078 [13]. The analyses presented here were not specified in detail in the original protocol; however, a separate detailed analysis plan was written prior to running the analyses reported here and was agreed by the Trial Steering Committee.

Demographics

Fig. 1 and Table 1 summarize the demographic data. Of the 722 infants randomized from February 2007 to January 2013, 719 (GA 358, RA 361) had data available for analysis. A total of 711 infants (98.5%) underwent inguinal hernia repair (GA 355, RA 356), with data on type of exploration available on 674 patients and data on hernia repair in 653. In total, 557 patients (78.3%) (GA 282, RA 275) had both baseline hernia surgery and 2-year outcome data available. In the RA group, 286 patients out of

Discussion

A recent report by Wang and the Committee on Fetus and Newborn and Section on Surgery of the American Academy of Pediatrics in 2012 concluded that: “Given the lack of data supporting evidence-based approaches to inguinal hernias in infants, consideration should be given to large, prospective, randomized, controlled trials to answer these important questions” [1]. Although our large multicenter RCT was not primarily aimed at determining the surgical outcome 2 years after the primary hernia

Acknowledgments

GAS Consortium

Australia:

Andrew J. Davidson and Geoff Frawley (Department of Anaesthesia and Pain Management, Murdoch Childrens Research Institute and The Royal Children’s Hospital and University of Melbourne, Melbourne, Australia); Pollyanna Hardy (National Perinatal Epidemiology Unit, Clinical Trials Unit, University of Oxford, Oxford, UK); Sarah J. Arnup, Tibor Schuster and Katherine Lee (Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne,

Funding sources

All hospitals and centers were generously supported by departmental funding.

In addition to this funding, specific grants received for this study are as follows:

Australia: The Australian National Health & Medical Research Council (Project Grants #1002906 and 491226); Australian and New Zealand College of Anaesthetists (Project Grant #11/021 and 07/012); The Murdoch Childrens Research Institute. This study was supported by the Victorian Government’s Operational Infrastructure Support Program.

USA:

References (23)

  • G. Vaos et al.

    Optimal timing for repair of an inguinal hernia in premature infants

    Pediatr Surg Int

    (2010)
  • Cited by (15)

    • Anaesthesia for surgery in infancy

      2023, Anaesthesia and Intensive Care Medicine
      Citation Excerpt :

      The open procedure is relatively quick (approximately 30 minutes per side), and involves ligating a patent processus vaginalis into which herniation has occurred. The procedure can also be performed laparoscopically, even in small or premature infants or when the hernia is incarcerated.1 The main proposed benefit of a laparoscopic approach is that it allows exploration of the contralateral side, and ligation of a second patent processus vaginalis if present.

    • Feasibility, safety and outcome of inguinal hernia repair under spinal versus general anesthesia in preterm and term infants

      2021, Journal of Pediatric Surgery
      Citation Excerpt :

      In case of intraoperative agitation, crying, or movements of the upper part of the body, gentle manual containment and/or a sucrose-sweetened pacifier maintained in the baby's mouth were successful to obtain control of the baby, instead of switching to GA. Our outcomes on SA parallel those reported in a previous Cochrane review and in a subsequent randomized study, which did not demonstrate any difference between all types of RA and GA in preterm infants undergoing IHR, in terms of duration of surgery and average length of hospital stay [20,21]. Regarding postoperative pain, we adopted the FLACC score, which is a validated behavioral scale for scoring postoperative pain in young children who are unable to communicate their pain [11].

    • Anaesthesia for surgery in infancy

      2020, Anaesthesia and Intensive Care Medicine
      Citation Excerpt :

      The open procedure is relatively quick (approximately 30 min per side), and involves ligating a patent processus vaginalis into which herniation has occurred. The procedure can also be performed laparoscopically, even in small or premature infants or when the hernia is incarcerated.1 Unilateral hernia repair is likely to be faster when performed as an open procedure, but the main proposed benefit of a laparoscopic approach is that it allows exploration of the contralateral side, and ligation of a second patent processus vaginalis if present.

    • Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial

      2019, The Lancet
      Citation Excerpt :

      Assessment at 2 years was regarded as an interim or secondary outcome because neurodevelopmental delays can be measured more accurately at 5 years of age. Data relating to apnoea in the immediate postoperative period, intraoperative blood pressure, regional anaesthesia, and surgical outcomes from the GAS trial were also published previously.17–20 In this Article, we report the primary outcome of the trial, in addition to various secondary outcomes, measured at age 5 years.

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    Conflict of Interest: All authors have no conflict of interest to disclose.

    ☆☆

    Clinical Trial Registration: This trial is registered with ANZCTR, number ACTRN12606000441516, ClinicalTrials.gov, number NCT00756600, and the UK Clinical Research Network (UKCRN), number 12437565.

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