Surgical treatment of Necrotizing Enterocolitis: what can we learn from observational studies and what do randomized controlled trials add?

Heesewijk, A.E. van (2014) Surgical treatment of Necrotizing Enterocolitis: what can we learn from observational studies and what do randomized controlled trials add? thesis, Medicine.

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Abstract

Objective: To assess what can we learn from observational studies concerning surgical treatment of necrotizing enterocolitis ( NEC) and to determine what randomized controlled trials add to this knowledge. Data source: PubMed and the Cochrane Database of Systematic Reviews were searched to identify articles focused on the surgical treatment of NEC. Articles published between January 1, 1990 and November 11, 2013 were retrieved for further screening. Methods: Publications were eligible for inclusion when they fulfilled the following criteria: 1) low birth weight (<2500 grams) 2) preterm infants (< 37 weeks of gestational age) 3) comparison of surgical treatment of NEC; side by side comparison of laparotomy and peritoneal drainage 4) reporting of the primary outcome of mortality. Standardized checklists were used to assess the methodological quality and risk of bias in both the observational studies and the randomized controlled trials. The methodological quality of reporting of observational studies was assessed with the “Strengthening the Reporting of Observational Studies in Epidemiology” (STROBE) checklist. The Consolidated Standards of Reporting Trials (CONSORT) guidelines were used to assess the reporting quality of RCTs. Main outcome: Our primary outcome was within 90 days of surgery, within six months of surgery, before discharge or at one year corrected age. Results: Meta-analysis of all included 23 observational studies shows a significant difference in terms of overall mortality favoring laparotomy (pooled OR 0.5, CI 0.29-0.86). The two randomized controlled trials show no significant difference in terms of overall mortality between drainage and laparotomy (pooled OR 0.81; CI 0.43-1.51). A post-hoc analysis showed a significant increase of percentage of STROBE criteria met over time. These results prompted us to divide our observational studies into two groups based on the median proportion of STROBE criteria met. Using this definition of high and low quality, when only high quality observational studies are considered, comparison between observational studies and RCTs shows the same non-significant difference in mortality between infants who undergo laparotomy and those who undergo drainage.

Item Type:	Thesis (Thesis)
Supervisor name:	Huizenga, Dr.Ing. J.R. and Bos, Professor A.F.
Supervisor name:	Schmidt, Professor B. and deMauro, Dr. S.B. and Perelman School of Medicine and University of Pennsylvania, USA
Faculty:	Medical Sciences
Date Deposited:	25 Jun 2020 10:46
Last Modified:	25 Jun 2020 10:46
URI:	https://umcg.studenttheses.ub.rug.nl/id/eprint/771

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