Hernia Exploration oR Not In Infants Analysis (HERNIIA)
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Contralateral exploration
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Metachronous contralateral inguinal hernia, Hernia repair, Contralateral exploration, Cost-effectiveness, Infants
Eligibility Criteria
Inclusion Criteria:
Infants aged younger than six months at first presentation with a primary unilateral inguinal hernia undergoing open hernia repair are considered eligible for inclusion.
Exclusion Criteria:
Infants with (1) incarcerated inguinal hernia requiring urgent surgery, (2) a ventricular-peritoneal drain, (3) non-descended testis.
Sites / Locations
- Amsterdam UMC, Vrije Universiteit Amsterdam
- Emma Children's Hospital, Amsterdam UMC, University of Amsterdam
- Juliana Children's Hospital, HagaZiekenhuis
- University Medical Center Groningen
- Maastricht University Medical Center
- Erasmus MC - Sophia Children's Hospital
- Máxima Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Unilateral inguinal hernia repair with contralateral exploration.
Unilateral inguinal hernia repair.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total duration of operation(s) including anaesthesia time and hospital admission(s)
Total duration of operation(s) including anaesthesia time and total duration of hospital admission(s) related to inguinal hernia within one year after primary repair
Complications of anaesthesia and surgery
Occurence of wound infection, hematoma, hydrocele, testicular atrophy, apnoea or recurrence of inguinal hernia, related to hernia repair.
Health-related quality of life (HRQOL) of the operated infant
HRQOL of the operated infants is measured by the TAPQOL (TNO-AZL Preschool Children Quality of Life), a parent-reported questionnaire that is clustered into 12 multi-item scales, with higher scores (range 0-100) indicating better HRQOL.
Parental distress and anxiety
Parental distress and anxiety of the families of the operated infants is measured by 1) State-Trait Anxiety Inventory (STAI), used as an indicator of parental distress, and 2) Distress Thermometer for Parents (DT-P), a well-validated, brief screening instrument that is frequently used in clinical practice in the Netherlands as a quick screener to identify distress and everyday problems in parents of children who need medical treatment.
Full Information
NCT ID
NCT03623893
First Posted
August 2, 2018
Last Updated
May 17, 2023
Sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03623893
Brief Title
Hernia Exploration oR Not In Infants Analysis
Acronym
HERNIIA
Official Title
A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
There is a high incidence of metachronous (i.e. a second) contralateral inguinal hernia (MCIH) in infants with an inguinal hernia (5-30%, most studies report 10%), with the highest risk in infants aged less than 6 months. Metachronous hernia is associated with the risk of incarceration and general risks and costs of a second operation. This can potentially be avoided by contralateral exploration at the first operation. On the other hand contralateral exploration may turn out to be unnecessary, is associated with additional operating time and cost, and may be associated with additional complications of surgery (including testicular atrophy, wound infection) and anesthesia. Both policies to routinely explore the contralateral side or not are used in the treatment of unilateral inguinal hernias in children. There is no high-grade level of evidence of the superiority of one of either policy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Metachronous contralateral inguinal hernia, Hernia repair, Contralateral exploration, Cost-effectiveness, Infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter randomized controlled trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants and care providers are aware of allocation; masking is impossible because of the nature of the intervention.
Allocation
Randomized
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Other
Arm Description
Unilateral inguinal hernia repair with contralateral exploration.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Unilateral inguinal hernia repair.
Intervention Type
Procedure
Intervention Name(s)
Contralateral exploration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of infants that undergo a second operation
Description
The number of infants that undergo a second operation related to unilateral inguinal hernia within one year after primary inguinal hernia repair
Time Frame
One year after primary hernia repair
Secondary Outcome Measure Information:
Title
Total duration of operation(s) including anaesthesia time and hospital admission(s)
Description
Total duration of operation(s) including anaesthesia time and total duration of hospital admission(s) related to inguinal hernia within one year after primary repair
Time Frame
One year after primary hernia repair
Title
Complications of anaesthesia and surgery
Description
Occurence of wound infection, hematoma, hydrocele, testicular atrophy, apnoea or recurrence of inguinal hernia, related to hernia repair.
Time Frame
During hospital admission, four weeks and one year after primary hernia repair
Title
Health-related quality of life (HRQOL) of the operated infant
Description
HRQOL of the operated infants is measured by the TAPQOL (TNO-AZL Preschool Children Quality of Life), a parent-reported questionnaire that is clustered into 12 multi-item scales, with higher scores (range 0-100) indicating better HRQOL.
Time Frame
At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
Title
Parental distress and anxiety
Description
Parental distress and anxiety of the families of the operated infants is measured by 1) State-Trait Anxiety Inventory (STAI), used as an indicator of parental distress, and 2) Distress Thermometer for Parents (DT-P), a well-validated, brief screening instrument that is frequently used in clinical practice in the Netherlands as a quick screener to identify distress and everyday problems in parents of children who need medical treatment.
Time Frame
At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, before and four weeks after re-operation
Other Pre-specified Outcome Measures:
Title
Economic evaluation
Description
Total health care costs associated with each strategy, assessed by a retrospective cost questionnaire and the iMTA Productivity Cost Questionnaire (iPCQ).
Time Frame
Four weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants aged younger than six months at first presentation with a primary unilateral inguinal hernia undergoing open hernia repair are considered eligible for inclusion.
Exclusion Criteria:
Infants with (1) incarcerated inguinal hernia requiring urgent surgery, (2) a ventricular-peritoneal drain, (3) non-descended testis.
Facility Information:
Facility Name
Amsterdam UMC, Vrije Universiteit Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Emma Children's Hospital, Amsterdam UMC, University of Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Juliana Children's Hospital, HagaZiekenhuis
City
Den Haag
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
Erasmus MC - Sophia Children's Hospital
City
Rotterdam
Country
Netherlands
Facility Name
Máxima Medical Center
City
Veldhoven
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34593022
Citation
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.
Results Reference
derived
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