The objective of this study is to determine whether early inguinal hernia repair (prior to discharge home) or late inguinal hernia repair (approximately 5 months after discharge home) is the safer surgical approach for premature infants who are…
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the proportion of infants with * 1 Serious
Adverse Event (SAE), measured from enrolment through 10 months after
enrolment.
Secondary outcome
1. Compare the overall safety of early and late IH repair with respect to
neurodevelopmental outcome assessed with intra-operative measurements and at
22-26 months corrected age (at selected sites with well-established follow up
programs).
2. Using Bayesian and frequentist analyses, evaluate specific hypotheses about
patient characteristics that may influence the relative safety of early and
late IH repair.
3. To conduct the HIP Trial in an exemplary manner and thereby promote the
newly established American pediatric Surgery Research Collaborative (pedSRC) as
an ongoing research network
Background summary
Very few commonly used neonatal surgical therapies have been evaluated to
determine their safety. Due to the lack of evidence, current decision- making
regarding neonatal surgery relies primarily on the preferences of the surgeons
and neonatologists. As IH repair in premature infants is the most commonly
performed operation in premature infants with an associated morbidity of
30-40%, we have chosen to focus on this group. It is unknown whether the IH
repair prior to discharge home or delayed IH repair is the safer approach in
premature infants.
Study objective
The objective of this study is to determine whether early inguinal hernia
repair (prior to discharge home) or late inguinal hernia repair (approximately
5 months after discharge home) is the safer surgical approach for premature
infants who are diagnosed with an inguinal hernia while in the NICU. In order
to do so, several centres throughout the Netherlands will be collaborating with
a multicentre RCT conducted by the Vanderbilt University Medical Center. The
Erasmus MC will be the coordinating center in the Netherlands.
Study design
International multicentre randomized pragmatic clinical trial. Randomization
will be stratified according to site and GA (gestational age) strata (<28 weeks
and * 28 weeks estimated GA) to further ensure as equal risk groups as
possible.
Intervention
The early inguinal hernia repair group will be operated on before discharge
home (~38 weeks PMA (post menstrual age)). The late inguinal hernia repair
group in comparison will be operated on 5 months after discharge home (60 weeks
PMA).
Study burden and risks
Two additional assessments will take place in the postoperative period (one as
an outpatient visit and one by phone). After this the patient will enter the
follow-up phase for neurodevelopmental assessment. This requires additional
neurodevelopmental assessments, which will be combined with standard of care
visits to assure minimal burden for the participants and caretakers. The burden
of the eye-tracking examination is minimal as it is non- invasive, there will
be no intervention and it does not require active participation of the child.
The eye-tracking session will take 15 minutes with a maximum op to 30 minutes.
The Bayley Score of Infant Development wille be performed af 2 years of age and
the assessement will take up to 90 minutes.
Risk related to timing of operation
Current decision-making regarding inguinal hernia repair relies primarily on
the preferences of the surgeons and neonatologists partly due to lack of
evidence. Current care differs from early repair (before discharge) and late
repair (> 60 PMA). There is a void in our clinical knowledge regarding safety
and optimal time of operation. For early repair there may be greater risk of
complications from general anesthesia and the operation may be more challenging
to perform. In the late repair group there may be risk of hernia incarceration
and strangulation of the trapped bowel which could result in emergency surgery.
Anaesthesia risk
The majority of the premature infants undergoing IH repair have general
anaesthesia. Multiple studies have identified an association between general
anaesthesia and neurotoxicity, however none of these studies were randomized
clinical trials and have serious limitations as such. Inguinal hernia repair is
considered the standard and required treatment for infants with an inguinal
hernia. Anaesthesia is a necessary component of this surgical treatment.
The inguinal hernia is anatomically different in early childhood than it is at
a later age. It also is more frequently seen in premature infants (~50%) and
requires surgical care. The inguinal hernia, the operation and the associated
age related problems are specific for this patient group.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1) gestational age (GA)<37 weeks
2) diagnosed with inguinal hernia by pediatric surgeon
3) diagnosed during hospital stay
4) Parental informed consent
Exclusion criteria
1) Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure
2) Associated factor impacts timing of IH repair
3) Known major congenital anomaly or chromosomal abnormality (specified in protocol)
4) Family unable / unwilling to return for follow up or are not willing to participate if the patient is randomized for late IH repair;
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 |
|---|---|
| ClinicalTrials.gov | NCT01678638 |
| CCMO | NL56310.078.18 |