Hernia Exploration oR Not In Infants Analysis

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    378
  • sponsor
    VU University Medical Center
Updated on 21 October 2021
herniorrhaphy
repair of inguinal hernia

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.

Details
Condition INGUINAL HERNIA
Treatment Contralateral exploration
Clinical Study IdentifierNCT03623893
SponsorVU University Medical Center
Last Modified on21 October 2021

Eligibility

Yes No Not Sure

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
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