To study the effectiveness and cost-effectiveness of contralateral exploration as compared to no contralateral exploration in children aged 6 months or less that undergo unilateral inguinal hernia repair.
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of operations related to inguinal hernia within one year after inguinal
hernia repair.
Secondary outcome
Length of hospital stay related to inguinal hernia; Complications of surgery
(testicular atrophy, wound infection, apnoea, recurrence); Total duration of
operations (including anaesthesia) related to inguinal hernia repair; Direct
and indirect costs related to inguinal hernia repair within one year after
surgery; Health-related Quality of Life of the operated infants and
parents/caretakers.
Background summary
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). 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.
Study objective
To study the effectiveness and cost-effectiveness of contralateral exploration
as compared to no contralateral exploration in children aged 6 months or less
that undergo unilateral inguinal hernia repair.
Study design
A multicentre randomised controlled trial. Infants that need to undergo
unilateral inguinal hernia repair will be randomised to either contralateral
exploration or no contralateral exploration.
Intervention
Contralateral exploration or no contralateral exploration in chrildren with
unilateral inguinal hernia repair.
Study burden and risks
Burden: 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. No contralateral exploration may lead to development
of metachronous contralateral hernia with risk of incarceration, second
anaesthesia and general risks and costs of a second operation.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Infants aged 6 months or younger
Primary unilateral inguinal hernia
Undergoing open hernia repair
Exclusion criteria
Incarcerated inguinal hernia in need for an emergency operation
Ventricular-peritoneal drain
Non-descended testis
Parents who are not able to understand the nature or consequences of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59817.029.18 |
| Other | volgt nog |