Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04487522
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2020-07-08
Brief Title:
Pain and Quality of Life After Retromuscular Ventral Hernia Repair RECOVER
Sponsor:
Intuitive Surgical
Organization:
Intuitive Surgical
Study Overview
Official Title:
RECOVER a pRospECtive evaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
Status:
RECRUITING
Status Verified Date:
2023-09
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:
RECOVER
Brief Summary:
The study aims to explore the difference in outcomes relating to pain and quality of life after open laparoscopic and robotic-assisted retromuscular ventral hernia repair
Detailed Description:
This is a prospective multicenter observational study assessing outcomes relating to pain and quality of life for subjects undergoing open laparoscopic or robotic-assisted retromuscular ventral hernia repair The study will focus on short-term post-operative outcomes through 3 months The study will also collect recurrence data through 1 year During the post-operative period through 3 months pain medication intake subject reported pain on post-operative day 7 14 21 28 and 3 months and quality of life on day 28 3 months and 1 year and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected
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