Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

on behalf of the HERNIIA study group

doi:10.1186/s13063-021-05606-w

Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

on behalf of the HERNIIA study group

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

BACKGROUND: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely.

METHODS: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed.

DISCUSSION: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018.

Original language	English
Article number	670
Pages (from-to)	1-11
Number of pages	11
Journal	Trials
Volume	22
Issue number	1
Early online date	30 Sept 2021
DOIs	https://doi.org/10.1186/s13063-021-05606-w
Publication status	Published - Dec 2021

Bibliographical note

Funding Information:
This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript.

Funding Information:
We acknowledge the Child and Hospital Foundation (K&Z), and especially E. Schmidt-Cnossen, who gave advice about our study design and the parental information letter including the informed consent form, and will be closely involved throughout the whole project. In addition, we would like to thank all participating centres and collaborators involved in this project: E. Schmidt-Cnossen, L. Haverman, M. K?nigs, J. Oosterlaan, G.W. Zijp, R. van Baren, R.G.J. Visschers, H.R. Langeveld and M. Bender. Participating centres in the Netherlands are: Emma Children?s Hospital AMC, Amsterdam UMC; Amsterdam UMC, Vrije Universiteit Amsterdam; Maastricht University Medical Centre; Erasmus MC - Sophia Children?s Hospital Rotterdam; University Medical Centre Groningen, Juliana Children?s Hospital Den Haag and Maxima Medical Centre Veldhoven. JD and EH originated the study. KD, JD, JB, MR, JT, JO, MK and EH were involved in the study design, JB, MT, MR, JA, JG, MS, MK, and JO provided specific advice based on their expertise; KD and JD drafted the manuscript. All authors provided feedback to the consecutive versions of the manuscript and approved the final version. This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript.

Publisher Copyright:
© 2021, The Author(s).

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Funding

This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript. We acknowledge the Child and Hospital Foundation (K&Z), and especially E. Schmidt-Cnossen, who gave advice about our study design and the parental information letter including the informed consent form, and will be closely involved throughout the whole project. In addition, we would like to thank all participating centres and collaborators involved in this project: E. Schmidt-Cnossen, L. Haverman, M. K?nigs, J. Oosterlaan, G.W. Zijp, R. van Baren, R.G.J. Visschers, H.R. Langeveld and M. Bender. Participating centres in the Netherlands are: Emma Children?s Hospital AMC, Amsterdam UMC; Amsterdam UMC, Vrije Universiteit Amsterdam; Maastricht University Medical Centre; Erasmus MC - Sophia Children?s Hospital Rotterdam; University Medical Centre Groningen, Juliana Children?s Hospital Den Haag and Maxima Medical Centre Veldhoven. JD and EH originated the study. KD, JD, JB, MR, JT, JO, MK and EH were involved in the study design, JB, MT, MR, JA, JG, MS, MK, and JO provided specific advice based on their expertise; KD and JD drafted the manuscript. All authors provided feedback to the consecutive versions of the manuscript and approved the final version. This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript.

Funders	Funder number
Child and Hospital Foundation (K&Z
Juliana Children?s Hospital Den Haag and Maxima Medical Centre Veldhoven
ZonMw	852001903
Universitair Medisch Centrum Groningen

Keywords

Contralateral exploration
Cost-effectiveness
Infants
Inguinal hernia
Inguinal hernia repair
Metachronous hernia

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/s13063-021-05606-w

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@article{dd4a454d670348e19d43db6819036073,

title = "Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial",

abstract = "BACKGROUND: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely.METHODS: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed.DISCUSSION: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia.TRIAL REGISTRATION: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018.",

keywords = "Contralateral exploration, Cost-effectiveness, Infants, Inguinal hernia, Inguinal hernia repair, Metachronous hernia",

author = "Dreuning, {Kelly M.A.} and {van Tulder}, {Maurits W.} and Been, {Jasper V.} and Rovers, {Maroeska M.} and {de Graaff}, {Jurgen C.} and Stevens, {Markus F.} and Anema, {Johannes R.} and Twisk, {Jos W.R.} and {van Heurn}, {L. W.Ernest} and Derikx, {Joep P.M.} and {on behalf of the HERNIIA study group}",

note = "Funding Information: This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript. Funding Information: We acknowledge the Child and Hospital Foundation (K&Z), and especially E. Schmidt-Cnossen, who gave advice about our study design and the parental information letter including the informed consent form, and will be closely involved throughout the whole project. In addition, we would like to thank all participating centres and collaborators involved in this project: E. Schmidt-Cnossen, L. Haverman, M. K?nigs, J. Oosterlaan, G.W. Zijp, R. van Baren, R.G.J. Visschers, H.R. Langeveld and M. Bender. Participating centres in the Netherlands are: Emma Children?s Hospital AMC, Amsterdam UMC; Amsterdam UMC, Vrije Universiteit Amsterdam; Maastricht University Medical Centre; Erasmus MC - Sophia Children?s Hospital Rotterdam; University Medical Centre Groningen, Juliana Children?s Hospital Den Haag and Maxima Medical Centre Veldhoven. JD and EH originated the study. KD, JD, JB, MR, JT, JO, MK and EH were involved in the study design, JB, MT, MR, JA, JG, MS, MK, and JO provided specific advice based on their expertise; KD and JD drafted the manuscript. All authors provided feedback to the consecutive versions of the manuscript and approved the final version. This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript. Publisher Copyright: {\textcopyright} 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = dec,

doi = "10.1186/s13063-021-05606-w",

language = "English",

volume = "22",

pages = "1--11",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

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TY - JOUR

T1 - Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial)

T2 - study protocol for a multi-centre, randomised controlled trial

AU - Dreuning, Kelly M.A.

AU - van Tulder, Maurits W.

AU - Been, Jasper V.

AU - Rovers, Maroeska M.

AU - de Graaff, Jurgen C.

AU - Stevens, Markus F.

AU - Anema, Johannes R.

AU - Twisk, Jos W.R.

AU - van Heurn, L. W.Ernest

AU - Derikx, Joep P.M.

AU - on behalf of the HERNIIA study group

N1 - Funding Information: This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript. Funding Information: We acknowledge the Child and Hospital Foundation (K&Z), and especially E. Schmidt-Cnossen, who gave advice about our study design and the parental information letter including the informed consent form, and will be closely involved throughout the whole project. In addition, we would like to thank all participating centres and collaborators involved in this project: E. Schmidt-Cnossen, L. Haverman, M. K?nigs, J. Oosterlaan, G.W. Zijp, R. van Baren, R.G.J. Visschers, H.R. Langeveld and M. Bender. Participating centres in the Netherlands are: Emma Children?s Hospital AMC, Amsterdam UMC; Amsterdam UMC, Vrije Universiteit Amsterdam; Maastricht University Medical Centre; Erasmus MC - Sophia Children?s Hospital Rotterdam; University Medical Centre Groningen, Juliana Children?s Hospital Den Haag and Maxima Medical Centre Veldhoven. JD and EH originated the study. KD, JD, JB, MR, JT, JO, MK and EH were involved in the study design, JB, MT, MR, JA, JG, MS, MK, and JO provided specific advice based on their expertise; KD and JD drafted the manuscript. All authors provided feedback to the consecutive versions of the manuscript and approved the final version. This work is supported by The Netherlands Organisation for Health Research and Development (ZonMw), grant number 852001903. This is an investigator initiated clinical trial. Therefore, the funder (ZonMw) plays no role in the design of the study and collection, analysis and interpretation of data and in writing the manuscript. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/12

Y1 - 2021/12

N2 - BACKGROUND: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely.METHODS: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed.DISCUSSION: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia.TRIAL REGISTRATION: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018.

AB - BACKGROUND: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely.METHODS: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed.DISCUSSION: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia.TRIAL REGISTRATION: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018.

KW - Contralateral exploration

KW - Cost-effectiveness

KW - Infants

KW - Inguinal hernia

KW - Inguinal hernia repair

KW - Metachronous hernia

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Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

Access to Document

Persistent URL (handle)

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