Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551820
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2020-08-05
Brief Title:
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
Sponsor:
Intuitive Surgical
Organization:
Intuitive Surgical
Study Overview
Official Title:
SPARC Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2021-11
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:
SPARC
Brief Summary:
A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours
Detailed Description:
The study is a retrospective multi-center chart review study of short-term patient outcomes through 30 days after robotic-assisted cholecystectomies performed during regular hours and after-hours The primary outcomes include the rate of conversion to open rate of intra-operative adverse events the rate of post-operative adverse events relating to the cholecystectomy within 30 days and re-admissions and re-operations relating to the cholecystectomy within 30 days In addition operative time the rate of use of intra-operative imaging and the hospital length of stay will be collected as secondary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None