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Hernia Exploration oR Not In Infants Analysis (HERNIIA)

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ClinicalTrials.gov Identifier: NCT03623893
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
K.M.A. Dreuning, VU University Medical Center

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Contralateral exploration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter randomized controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants and care providers are aware of allocation; masking is impossible because of the nature of the intervention.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Intervention group
Unilateral inguinal hernia repair with contralateral exploration.
Procedure: Contralateral exploration
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.

No Intervention: Control group
Unilateral inguinal hernia repair.



Primary Outcome Measures :
  1. Number of infants that undergo a second operation [ Time Frame: One year after primary hernia repair ]
    The number of infants that undergo a second operation related to unilateral inguinal hernia.


Secondary Outcome Measures :
  1. Health care costs [ Time Frame: Four weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation ]
    Total health care costs associated with each strategy, assessed by a retrospective cost questionnaire and the iMTA Productivity Cost Questionnaire (iPCQ)

  2. Number of operation(s) [ Time Frame: One year after primary hernia repair ]
    Total number of operation(s) related to hernia repair.

  3. Duration of operation(s) [ Time Frame: One year after primary hernia repair ]
    Total duration (in minutes) of operation(s) including anesthesia time related to hernia repair.

  4. Number of hospital admission(s) [ Time Frame: One year after primary hernia repair ]
    Total number of hospital admission(s) related to hernia repair.

  5. Duration of hospital admission(s) [ Time Frame: One year after primary hernia repair ]
    Total duration (in days) of hospital admission(s) related to hernia repair.

  6. Complications [ Time Frame: One year after primary hernia repair ]
    Occurence of wound infection, hematoma/hydrocele, testicular atrophy, apnea or recurrence, related to hernia repair.

  7. Health-related quality of life (HRQOL) 1 [ Time Frame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation ]
    HRQOL of the operated infants, measured by the TAPQOL (TNO-AZL Preschool Children Quality of Life, parent-reported questionnaire that is clustered into 12 multi-item scales, with higher scores (range 0-100) indicating better HRQOL)

  8. Health-related quality of life (HRQOL) 2 [ Time Frame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation ]
    HRQOL of the families of the operated infants, measured by the State-Trait Anxiety Inventory (STAI, to measure trait and state anxiety and used as an indicator of parental distress)

  9. Health-related quality of life (HRQOL) 3 [ Time Frame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation ]
    HRQOL/parental distress of the families of the operated infants, measured by the 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.

  10. Neurocognitive development 1 [ Time Frame: At children's age of 18 months. ]
    Infant development assessed by the Ages & Stages Questionnaire.

  11. Neurocognitive development 2 [ Time Frame: At children's age of 18 months. ]
    Motor and cognitive development, assessed by the Bayley Scale of Infant Development.

  12. Neurocognitive development 3 [ Time Frame: At children's age of 18 months. ]
    Early attention, assessed by Eye-tracking using saturation and novelty detection paradigm.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants aged six months or younger with a primary unilateral inguinal hernia, undergoing open hernia repair.

Exclusion Criteria:

  • Children with;

    1. incarcerated inguinal hernia, who have to be operated urgently
    2. ventricular-peritoneal drain
    3. non-descended testis
  • Patients who receive bilateral inguinal hernia repair because of increased operation risks (e.g. poor pulmonary condition)
  • Parents who are not able to understand the nature or consequences of the study

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Responsible Party: K.M.A. Dreuning, Coordinating Investigator HERNIIA trial, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03623893     History of Changes
Other Study ID Numbers: 2017.596
852001903 ( Other Grant/Funding Number: ZonMw )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by K.M.A. Dreuning, VU University Medical Center:
Metachronous contralateral inguinal hernia
Hernia repair
Contralateral exploration
Cost-effectiveness
Infants
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal