NCT03623893

Brief Summary

This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than six months with a unilateral inguinal hernia. In half of the participants contralateral exploration will be performed, while in the other half only unilateral inguinal hernia repair will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

4.1 years

First QC Date

August 2, 2018

Last Update Submit

May 17, 2023

Conditions

Inguinal Hernia

Keywords

Metachronous contralateral inguinal herniaHernia repairContralateral explorationCost-effectivenessInfants

Outcome Measures

Primary Outcomes (1)

  • Proportion of infants that undergo a second operation

    The number of infants that undergo a second operation related to unilateral inguinal hernia within one year after primary inguinal hernia repair

    One year after primary hernia repair

Secondary Outcomes (4)

  • Total duration of operation(s) including anaesthesia time and hospital admission(s)

    One year after primary hernia repair

  • Complications of anaesthesia and surgery

    During hospital admission, four weeks and one year after primary hernia repair

  • Health-related quality of life (HRQOL) of the operated infant

    At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation

  • Parental distress and anxiety

    At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, before and four weeks after re-operation

Other Outcomes (1)

  • Economic evaluation

    Four weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation

Study Arms (2)

Intervention group

OTHER

Unilateral inguinal hernia repair with contralateral exploration.

Procedure: Contralateral exploration

Control group

NO INTERVENTION

Unilateral inguinal hernia repair.

Interventions

Contralateral explorationPROCEDURE

Surgery eventually performed when a patent processus vaginalis or hernia exists on the other side than the side on which the child has to be operated on, will be exactly the same as the inguinal hernia repair on the 'symptomatic' side. Exploration of the contralateral side will increase anaesthesia time by 10-15 minutes.

Intervention group

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Infants with (1) incarcerated inguinal hernia requiring urgent surgery, (2) a ventricular-peritoneal drain, (3) non-descended testis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Amsterdam UMC, Vrije Universiteit Amsterdam

Amsterdam, Netherlands

Location

Emma Children's Hospital, Amsterdam UMC, University of Amsterdam

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, Netherlands

Location

Juliana Children's Hospital, HagaZiekenhuis

The Hague, Netherlands

Location

Máxima Medical Center

Veldhoven, Netherlands

Location

Related Publications (1)

  • Dreuning KMA, van Tulder MW, Been JV, Rovers MM, de Graaff JC, Stevens MF, Anema JR, Twisk JWR, van Heurn LWE, Derikx JPM; HERNIIA study group. Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial. Trials. 2021 Sep 30;22(1):670. doi: 10.1186/s13063-021-05606-w.

    PMID: 34593022DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and care providers are aware of allocation; masking is impossible because of the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator HERNIIA trial

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 9, 2018

Study Start

April 17, 2019

Primary Completion

May 9, 2023

Study Completion

May 15, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Locations

NL(7)