Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367309
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-27
Brief Title:
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ALPINE
Brief Summary:
This study investigates on the effect of two different operative techniques to treat abdominal wall hernias
The goal of this clinical trial is to learn if the eTEP Extended totally extraperitoneal repair technique leads to a better outcome than the IPOM Intraperitoneal onlay mesh technique
The main questions it aims to answer are
pain after the operation
rate of complications
rate of recurrence and reoperations
quality of life
Participants will
Either be operated using the eTEP or the IPOM technique Be followed up either in person or via email phone call at day 1 day 7 day 14 6 weeks 6 months 1 3 and 5 years after the surgery to asses the above-stated main and some more outcomes
The goal of this clinical trial is to learn if the eTEP Extended totally extraperitoneal repair technique leads to a better outcome than the IPOM Intraperitoneal onlay mesh technique
The main questions it aims to answer are
pain after the operation
rate of complications
rate of recurrence and reoperations
quality of life
Participants will
Either be operated using the eTEP or the IPOM technique Be followed up either in person or via email phone call at day 1 day 7 day 14 6 weeks 6 months 1 3 and 5 years after the surgery to asses the above-stated main and some more outcomes
Detailed Description:
None
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