Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-06-03 @ 1:59 AM
Study NCT ID:
NCT03623893
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hernia Exploration oR Not In Infants Analysis
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERNIIA
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 852001903 | OTHER_GRANT | ZonMw | View |