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.

Key objectives

  1. 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?
  2. Determine whether choice of surgical strategy impacts core outcomes after initial treatment, and at one year of life?
  3. Develop definitions for low- and high-risk gastroschisis

Wider aims

  1. Develop an international, multi-centre paediatric surgical research network.
  2. Embed the core outcome set from the NETS¹ᴳ study as the standard for reporting outcomes in gastroschisis studies.
  3. Improve counselling and consenting of parents of infants with gastroschisis
  4. Inform management guidelines for infants with gastroschisis

Background

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[1][2][3][4][5][6]. There is currently also no accepted definition of high-risk gastroschisis[5][7][8][9][10]

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[11], 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[12].

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.

Participants

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.

Funding

National Institute for Health Research

Investigators

References

  1. ^ Kandasamy Y, Whitehall J, Gill A, Stalewski H. Surgical management of gastroschisis in North Queensland from 1988 to 2007. J Paediatr Child Health. 2010;46(1-2):40-4.
  2. ^ Villela Rodriguez J, Salinas Lopez MP, Navas R. [Medical-surgical course of neonates with gastroschisis according to time, abdominal closure method and intestinal involvement: six years of experience]. Cir Pediatr. 2009;22(4):217-22.
  3. ^ Bonnard A, Zamakhshary M, de Silva N, Gerstle JT. Non-operative management of gastroschisis: a case-matched study. Pediatr Surg Int. 2008;24(7):767-71.
  4. ^ Tsai MH, Huang HR, Chu SM, Yang PH, Lien R. Clinical features of newborns with gastroschisis and outcomes of different initial interventions: primary closure versus staged repair. Pediatr neonatol. 2010;51(6):320-5.
  5. a, b Payne NR, Pfleghaar K, Assel B, Johnson A, Rich RH. Predicting the outcome of newborns with gastroschisis. J Pediatr Surg. 2009;44(5):918-23.
  6. ^ Allin B, Tse W, Johnson P, Marven S, Knight M. Challenges of improving the evidence base in smaller surgical specialties, as highlighted by a systematic review of gastroschisis management. Unpublished Systematic Review2014.
  7. ^ Cowan KN, Puligandla PS, Laberge JM, Skarsgard ED, Bouchard S, Yanchar N, et al. The gastroschisis prognostic score: reliable outcome prediction in gastroschisis. Journal of pediatric surgery. 2012;47(6):1111-7.
  8. ^ 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.
  9. ^ 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.
  10. ^ Kassa AM, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. Journal of pediatric surgery. 2011;46(11):2108-14.
  11. ^ 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.
  12. ^ 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.