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Multi-centre prospective cohort study of diaphragmatic defect phenotype and repair in neonates with congenital diaphragmatic hernia: “The Defect Study”

Multi-centre prospective cohort study of diaphragmatic defect phenotype and repair in neonates with congenital diaphragmatic hernia: “The Defect Study”
Multi-centre prospective cohort study of diaphragmatic defect phenotype and repair in neonates with congenital diaphragmatic hernia: “The Defect Study”
Defect size and closure technique in neonates with congenital diaphragmatic hernia (CDH) has long-term consequences for morbidity in survivors. Although subjective operative reporting of the defect size has been standardized, objective evaluation is lacking. There is no reported optimum closure technique related to the size and position of the diaphragmatic defect. We aim to objectively describe diaphragmatic defects and repair methods, at the time of neonatal CDH repair, through a prospective multi-centre service evaluation project. We will evaluate all neonates born with CDH surviving to diaphragmatic repair. All specialist paediatric surgical centres in the UK, Ireland and New Zealand will be invited to participate. Non-identifiable patient data will be collected over a 24-month period using a REDCap database. Diaphragmatic defects and hemidiaphragm measurements will be recorded intra-operatively alongside standardized defect reporting. Closure technique and 1-year outcomes will be captured. Demographics and peri-operative data will be reported as median (interquartile range), mean (standard deviation) or categorical variables. Defect measurement will be calculated as an ellipse with area displayed as a histogram. Patch usage will be compared to the defect area using univariate logistic regression analysis. Univariate logistic regression analysis will also be used to assess for the association between peri-operative variables and complications. Where possible, a multi-variate regression analysis will be performed. Centres will register the project as service evaluation at each participating hospital site. The results will be submitted to an international peer reviewed journal and will be disseminated via appropriate international forums and through patient support networks (CDH-UK).
Eastwood, Mary Patrice
1662d674-7040-40e1-80fb-4d121a32328e
Harwood, Rachel
24728c26-1d7c-4751-b79b-7abf03cd5c3f
Rhodes, Hannah
0a549fd0-a40f-4f58-9d2e-53dec4b17ac8
Bethell, George Stephen
a485d94a-a308-44d0-a5c8-bc566106f280
Bradnock, Timothy J
9d2abacf-54a6-4676-900c-67bc0585aee8
Hall, Nigel
6919e8af-3890-42c1-98a7-c110791957cf
Paediatric Surgery Trainee Research Network
Eastwood, Mary Patrice
1662d674-7040-40e1-80fb-4d121a32328e
Harwood, Rachel
24728c26-1d7c-4751-b79b-7abf03cd5c3f
Rhodes, Hannah
0a549fd0-a40f-4f58-9d2e-53dec4b17ac8
Bethell, George Stephen
a485d94a-a308-44d0-a5c8-bc566106f280
Bradnock, Timothy J
9d2abacf-54a6-4676-900c-67bc0585aee8
Hall, Nigel
6919e8af-3890-42c1-98a7-c110791957cf

Paediatric Surgery Trainee Research Network (2022) Multi-centre prospective cohort study of diaphragmatic defect phenotype and repair in neonates with congenital diaphragmatic hernia: “The Defect Study”. Journal of Surgical Protocols and Research Methodologies, 1. (doi:10.1093/jsprm/snab009).

Record type: Article

Abstract

Defect size and closure technique in neonates with congenital diaphragmatic hernia (CDH) has long-term consequences for morbidity in survivors. Although subjective operative reporting of the defect size has been standardized, objective evaluation is lacking. There is no reported optimum closure technique related to the size and position of the diaphragmatic defect. We aim to objectively describe diaphragmatic defects and repair methods, at the time of neonatal CDH repair, through a prospective multi-centre service evaluation project. We will evaluate all neonates born with CDH surviving to diaphragmatic repair. All specialist paediatric surgical centres in the UK, Ireland and New Zealand will be invited to participate. Non-identifiable patient data will be collected over a 24-month period using a REDCap database. Diaphragmatic defects and hemidiaphragm measurements will be recorded intra-operatively alongside standardized defect reporting. Closure technique and 1-year outcomes will be captured. Demographics and peri-operative data will be reported as median (interquartile range), mean (standard deviation) or categorical variables. Defect measurement will be calculated as an ellipse with area displayed as a histogram. Patch usage will be compared to the defect area using univariate logistic regression analysis. Univariate logistic regression analysis will also be used to assess for the association between peri-operative variables and complications. Where possible, a multi-variate regression analysis will be performed. Centres will register the project as service evaluation at each participating hospital site. The results will be submitted to an international peer reviewed journal and will be disseminated via appropriate international forums and through patient support networks (CDH-UK).

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Accepted/In Press date: 6 December 2021
e-pub ahead of print date: 2 February 2022
Additional Information: Author Nigel Hall additional organisational unit affiliation: University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.

Identifiers

Local EPrints ID: 453134
URI: http://eprints.soton.ac.uk/id/eprint/453134
PURE UUID: 6de97460-971d-4ac7-8482-30b66dc35356
ORCID for Nigel Hall: ORCID iD orcid.org/0000-0001-8570-9374

Catalogue record

Date deposited: 08 Jan 2022 22:32
Last modified: 18 May 2022 01:40

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Contributors

Author: Mary Patrice Eastwood
Author: Rachel Harwood
Author: Hannah Rhodes
Author: George Stephen Bethell
Author: Timothy J Bradnock
Author: Nigel Hall ORCID iD
Corporate Author: Paediatric Surgery Trainee Research Network

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