Hernia Exploration oR Not In Infants Analysis

Inguinal Hernia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623893
• Other study ID #: 2017.596
• Secondary ID: 852001903
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: May 15, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, Vrije Universiteit Amsterdam	Amsterdam
Netherlands	Emma Children's Hospital, Amsterdam UMC, University of Amsterdam	Amsterdam
Netherlands	Juliana Children's Hospital, HagaZiekenhuis	Den Haag
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus MC - Sophia Children's Hospital	Rotterdam
Netherlands	Máxima Medical Center	Veldhoven

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic evaluation	Total health care costs associated with each strategy, assessed by a retrospective cost questionnaire and the iMTA Productivity Cost Questionnaire (iPCQ).	Four weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
Primary	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	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	One year after primary hernia repair
Secondary	Complications of anaesthesia and surgery	Occurence of wound infection, hematoma, hydrocele, testicular atrophy, apnoea or recurrence of inguinal hernia, related to hernia repair.	During hospital admission, four weeks and one year after primary hernia repair
Secondary	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.	At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
Secondary	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.	At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, before and four weeks after re-operation