To study the most relevant outcome measures and a cost-effectiveness analysis of laparoscopic PIRS technique compared to open hernia repair in infants aged 6 months to 16 years of age with a primary unilateral inguinal hernia
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Number of operations related to inguinal hernia within two
year after inguinal hernia repair.
Secondary outcome
Duration of surgery, operative and postoperative complications, use of
different anaesthetic techniques, duration of hospital admission, postoperative
pain, time to full recovery, CPPV-rate, cosmetic appearance and
cost-effectiveness (health care and social costs).
Background summary
Paediatric inguinal hernia repair is one of the most frequently performed
operations in children. Treatment is necessary because of the risk of
incarceration of bowel, testis or ovary, which occurs in approximately 3-16% of
children with inguinal hernia. Open inguinal hernia repair is the most
performed treatment strategy in children, however, laparoscopic inguinal hernia
repair in children is increasingly performed as it allows easy contralateral
inspection and potentially results in shorter operation time and fewer
complications. Evidence regarding the superiority of laparoscopic versus open
hernia repair is lacking in children.
Study objective
To study the most relevant outcome measures and a cost-effectiveness analysis
of laparoscopic PIRS technique compared to open hernia repair in infants aged 6
months to 16 years of age with a primary unilateral inguinal hernia
Study design
A randomized controlled trial. Infants that need to undergo inguinal hernia
repair will be randomized to either open or laparoscopic correction.
Intervention
Open hernia repair or laparoscopic Percutaneous Internal Ring Sutering (PIRS)
repair
Study burden and risks
Both the open and PIRS technique are commonly used techniques in paediatric
inguinal hernia repair and are dependent of the surgeon performing the
procedure. Therefore, no extra burden of risk exist regarding this study. Both
treatment strategies are currently performed in children with unilateral
inguinal hernia who need to undergo hernia repair. Consequently, there are no
additional risks for subjects of this study and it is therefore not necessary
to install a Data Safety Monitoring Board (DSMB).
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: infants aged 0 to 16 years of age with a primary
unilateral inguinal hernia, undergoing hernia repair.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: Children with 1. incarcerated inguinal
hernia, which have to be operated urgently, 2. recurrent hernia 3.
ventricular-peritoneal drain, 4. non-descended testis, 5. 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 | NL71765.029.20 |