NETS²ᴳ - Gastroschisis
An international, multi-centre cohort study of infants with gastroschisis identified through BAPS-CASS and the Canadian Paediatric Surgery Network (CAPSNet) will be performed. This study will investigate the impact that both pre-operative, and operative factors have on core outcomes identified in the NETS¹ᴳ study.
- Determine whether 5-minute APGAR scores and the macroscopic appearance of the infant’s extruded organs at birth impact core outcomes after initial treatment and at one year of life?
- Determine whether choice of surgical strategy impacts core outcomes after initial treatment, and at one year of life?
- Develop definitions for low- and high-risk gastroschisis
- Develop an international, multi-centre paediatric surgical research network.
- Embed the core outcome set from the NETS¹ᴳ study as the standard for reporting outcomes in gastroschisis studies.
- Improve counselling and consenting of parents of infants with gastroschisis
- Inform management guidelines for infants with gastroschisis
Treatment of gastroschisis comprises two stages; visceral reduction, and defect closure. Methods of visceral reduction include ward-based reduction (WBR), non-operative silo reduction (NSR), operative reduction under general anaesthesia (OR), and operative silo reduction (OSR). Closure can be suture-less, sutured, patched, or via secondary intention. It is currently unclear which gives the best outcomes. There is currently also no accepted definition of high-risk gastroschisis.
It is not presently possible to perform a randomised controlled trial (RCT) comparing the two main methods of treatment, OR and NSR, as despite community equipoise existing, each individual surgeon has a strongly held belief in their chosen repair method. Surgeons are therefore unwilling to randomise between treatments, resulting in the only attempted RCT comparing these interventions failing to recruit.
Conducting a large-scale observational study investigating the impact of both pre-operative and operative factors on core outcomes for infants with gastroschisis is therefore essential. This will help to define low- and high-risk populations of infants with gastroschisis and make a meaningful assessment of whether equipoise exists between surgical repair strategies.
This study will be an international, multi-centre cohort study of infants with gastroschisis identified through BAPS-CASS and CAPSNet datasets. Between these datasets, we have 1300 infants with initial admission information, and 301 with one-year follow up. Secondary analysis of the previously prospectively collected data that forms these datasets will be performed.
The full study protocol will be published here shortly.
- Mr Benjamin Allin, National Perinatal Epidemiology Unit.
- Mr Sean Marven, Sheffield Children’s Hospital
- Dr Erik Skarsgard, BC Children’s Hospital, Vancouver.
- Professor Jenny Kurinczuk, National Perinatal Epidemiology Unit
- Professor Marian Knight, National Perinatal Epidemiology Unit
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- ^ Molik KA, Gingalewski CA, West KW, Rescorla FJ, Scherer LR, Engum SA, et al. Gastroschisis: a plea for risk categorization. Journal of pediatric surgery. 2001;36(1):51-5.
- ^ Clark RH, Walker MW, Gauderer MW. Factors associated with mortality in neonates with gastroschisis. European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery [et al] = Zeitschrift fur Kinderchirurgie. 2011;21(1):21-4.
- ^ Kassa AM, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. Journal of pediatric surgery. 2011;46(11):2108-14.
- ^ Owen A, Marven S, Johnson P, Kurinczuk J, Spark P, Draper ES, et al. Gastroschisis: A national cohort study to describe contemporary surgical strategies and outcomes. Journal of pediatric surgery. 2010;45(9):1808-16.
- ^ Pastor AC, Phillips JD, Fenton SJ, Meyers RL, Lamm AW, Raval MV, et al. Routine use of a SILASTIC spring-loaded silo for infants with gastroschisis: a multicenter randomized controlled trial. J Pediatr Surg. 2008;43(10):1807-12.