Avoidance of routine endotracheal intubation and general anesthesia for primary closure of gastroschisis: a systematic review and meta-analysis

Abstract

Purpose

Over the last few decades, several articles have examined the feasibility of attempting primary reduction and closure of gastroschisis without general anesthesia (GA). We aimed to systematically evaluate the impact of forgoing routine intubation and GA during primary bedside reduction and closure of gastroschisis.

Methods

The primary outcome was closure success. Secondary outcomes were mortality, time to enteral feeding, and length of hospital stay.

Results

12 studies were included: 5 comparative studies totalling 192 patients and 7 descriptive case studies totalling 56 patients. Primary closure success was statistically equivalent between the two groups, but trended toward improved success with GA/intubation (RR = 0.86, CI 0.70–1.03, p = 0.08). Mortality was equivalent between groups (RR = 1.26, CI 0.26–6.08, p = 0.65). With respect to time to enteral feeds and length of hospital stay, outcomes were either equivalent between the two groups or favored the group that underwent primary closure without intubation and GA.

Conclusion

There are few comparative studies examining the impact of performing primary bedside closure of gastroschisis without GA. A meta-analysis of the available data found no statistically significant difference when forgoing intubation and GA. Foregoing GA also did not negatively impact time to enteral feeds, length of hospital stay, or mortality.

Appendices

Appendix 1 Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] Guidelines

Section and Topic	Item #	Checklist item	Location where item is reported
TITLE
Title	1	Identify the report as a systematic review	p. 1
ABSTRACT
Abstract	2	See the PRISMA 2020 for abstracts checklist	p. 3
INTRODUCTION
Rationale	3	Describe the rationale for the review in the context of existing knowledge	p. 5–6
Objectives	4	Provide an explicit statement of the objective[s] or question[s] the review addresses	p. 6
METHODS
Eligibility criteria	5	Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses	p. 7
Information sources	6	Specify all databases, registers, websites, organizations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted	p. 6–7
Search strategy	7	Present the full search strategies for all databases, registers and websites, including any filters and limits used	p. 6–7
Selection process	8	Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process	p. 8
Data collection process	9	Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process	p. 8
Data items	10a	List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought [e.g., for all measures, time points, analyses], and if not, the methods used to decide which results to collect	p. 7–8
	10b	List and define all other variables for which data were sought [e.g., participant and intervention characteristics, funding sources]. Describe any assumptions made about any missing or unclear information	NA
Study risk of bias assessment	11	Specify the methods used to assess risk of bias in the included studies, including details of the tool[s] used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process	p. 8–9/p. 22
Effect measures	12	Specify for each outcome the effect measure[s] [e.g., risk ratio, mean difference] used in the synthesis or presentation of results	p. 9–10
Synthesis methods	13a	Describe the processes used to decide which studies were eligible for each synthesis [e.g., tabulating the study intervention characteristics and comparing against the planned groups for each synthesis [item #5]]	p. 7–8
	13b	Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions	p. 8–9
	13c	Describe any methods used to tabulate or visually display results of individual studies and syntheses	NA
	13d	Describe any methods used to synthesize results and provide a rationale for the choice[s]. If meta–analysis was performed, describe the model[s], method[s] to identify the presence and extent of statistical heterogeneity, and software package[s] used	p. 9–10
	13e	Describe any methods used to explore possible causes of heterogeneity among study results [e.g., subgroup analysis, meta–regression]	NA
	13f	Describe any sensitivity analyses conducted to assess robustness of the synthesized results	NA
Reporting bias assessment	14	Describe any methods used to assess risk of bias due to missing results in a synthesis [arising from reporting biases]	p. 8
Certainty assessment	15	Describe any methods used to assess certainty [or confidence] in the body of evidence for an outcome	NA
RESULTS
Study selection	16a	Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram	p. 10
	16b	Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded	p. 10
Study characteristics	17	Cite each included study and present its characteristics	Tables 1 and 2
Risk of bias in studies	18	Present assessments of risk of bias for each included study	p. 10 and 22
Results of individual studies	19	For all outcomes, present, for each study: [a] summary statistics for each group [where appropriate] and [b] an effect estimate and its precision [e.g., confidence/credible interval], ideally using structured tables or plots	Forrest plot
Results of syntheses	20a	For each synthesis, briefly summarize the characteristics and risk of bias among contributing studies	Table 1/p. 22/p. 10
	20b	Present results of all statistical syntheses conducted. If meta–analysis was done, present for each the summary estimate and its precision [e.g., confidence/credible interval] and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect	NA
	20c	Present results of all investigations of possible causes of heterogeneity among study results	NA
	20d	Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results	NA
Reporting biases	21	Present assessments of risk of bias due to missing results [arising from reporting biases] for each synthesis assessed	NA
Certainty of evidence	22	Present assessments of certainty [or confidence] in the body of evidence for each outcome assessed	Forest plot
DISCUSSION
Discussion	23a	Provide a general interpretation of the results in the context of other evidence	p. 13
	23b	Discuss any limitations of the evidence included in the review	p. 15
	23c	Discuss any limitations of the review processes used	p. 15
	23d	Discuss implications of the results for practice, policy, and future research	p. 15
OTHER INFORMATION
Registration and protocol	24a	Provide registration information for the review, including register name and registration number, or state that the review was not registered	p. 16
	24b	Indicate where the review protocol can be accessed, or state that a protocol was not prepared	p. 16
	24c	Describe and explain any amendments to information provided at registration or in the protocol	NA
Support	25	Describe sources of financial or non–financial support for the review, and the role of the funders or sponsors in the review	p. 2
Competing interests	26	Declare any competing interests of review authors	p. 2
Availability of data, code and other materials	27	Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review	p. 16

Appendix 2: MINORS tool for risk-of-bias assessment for descriptive and comparative studies

		Vane	Bianchi	Dolgin	Kimble	Duncan	Gore	Kasat	Davies	Cauchi	Rao	Pet	Briganti
Descriptive
Clearly stated aim		1	1	1	2	2	2	2	2	2	2	2	2
Inclusion of consecutive patients		2	2	2	2	0	2	0	2	2	2	2	2
Prospective collection of data		2	0	0	2	0	0	0	2	1	2	0	1
Endpoints appropriate to aim		2	2	1	2	2	1	2	2	2	2	2	2
Unbiased assessment of endpoint		0	0	0	0	0	0	0	0	0	0	0	0
Follow-up period appropriate to aim		2	2	2	2	2	2	0	2	2	2	2	2
Loss of follow-up < 5%		2	2	2	2	2	2	2	2	2	2	2	2
Prospective calculation of study size		0	0	0	0	0	0	0	0	0	0	0	0
Comparative
Adequate control group		NA	NA	NA	NA	NA	NA	NA	2	2	2	2	2
Contemporary group		NA	NA	NA	NA	NA	NA	NA	1	2	2	2	2
Baseline equivalence of groups		NA	NA	NA	NA	NA	NA	NA	2	2	1	2	2
Adequate statistical analyses		NA	NA	NA	NA	NA	NA	NA	2	2	2	2	2
Total		11	9	8	12	8	9	6	19	19	19	18	19