Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451432
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-27
Brief Title:
The Cost- Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Hernia Endoscopic oR opeN Repair In chIldren Analysis A Randomized Controlled Trial to Study the Cost- Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
Status:
RECRUITING
Status Verified Date:
2024-06
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-2
Brief Summary:
This study assess the cost-effectiveness of open versus laparoscopic Percutaneous Inguinal Ring Suturing PIRS technique for unilateral inguinal hernia repair in children aged 0-16 years
Detailed Description:
Research question Inguinal hernia repair is one of the most common operations in children After open unilateral inguinal hernia repair 6-8 of patients develops an inguinal hernia on the contralateral side Laparoscopic inguinal hernia offers the opportunity to inspect the contralateral groin and repair an asymptomatic contralateral hernia if present
Main question What is the most cost-effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years the open or laparoscopic Percutaneous Inguinal Ring Suturing PIRS technique
Hypothesis The optimal treatment for children with an inguinal hernia is laparoscopic hernia repair since the surgeon can inspect and possibly repair the contralateral groin Laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia less hospital admissions lower costs and a better quality of life compared to open inguinal hernia repair
Study design Multicentre randomized controlled trial
Study population Children aged 0 - 16 years with a unilateral inguinal hernia
Intervention Inguinal hernia repair with the laparoscopic PIRS technique
Usual carecomparison Inguinal hernia repair with the open technique
Outcome Measures Primary Number of operations related to inguinal hernia repair and cost-effectiveness social and healthcare related costs Secondary complications total duration of surgery including anaesthesia and total duration of operating room time post-operative pain length of hospital stay time to normal daily activities cosmetic appearance health-related quality of life All outcome measures will be assessed within two years after the primary inguinal hernia correction
Sample sizedata analysis 464 patients power of 080 alpha 005 Cost-effectiveness analysisbudget impact analysis The economic evaluation will be assessed from a societal and health care perspective Cost-effectiveness will be assessed in terms of QALYs and the primary and secondary outcomes A budget impact analysis will be conducted using the Budget Impact Analyse - leidraad en rekentool of ZonMw Missing data will be imputed
Main question What is the most cost-effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years the open or laparoscopic Percutaneous Inguinal Ring Suturing PIRS technique
Hypothesis The optimal treatment for children with an inguinal hernia is laparoscopic hernia repair since the surgeon can inspect and possibly repair the contralateral groin Laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia less hospital admissions lower costs and a better quality of life compared to open inguinal hernia repair
Study design Multicentre randomized controlled trial
Study population Children aged 0 - 16 years with a unilateral inguinal hernia
Intervention Inguinal hernia repair with the laparoscopic PIRS technique
Usual carecomparison Inguinal hernia repair with the open technique
Outcome Measures Primary Number of operations related to inguinal hernia repair and cost-effectiveness social and healthcare related costs Secondary complications total duration of surgery including anaesthesia and total duration of operating room time post-operative pain length of hospital stay time to normal daily activities cosmetic appearance health-related quality of life All outcome measures will be assessed within two years after the primary inguinal hernia correction
Sample sizedata analysis 464 patients power of 080 alpha 005 Cost-effectiveness analysisbudget impact analysis The economic evaluation will be assessed from a societal and health care perspective Cost-effectiveness will be assessed in terms of QALYs and the primary and secondary outcomes A budget impact analysis will be conducted using the Budget Impact Analyse - leidraad en rekentool of ZonMw Missing data will be imputed
Study Oversight
Has Oversight DMC:
None
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?:
None