Trials / Completed
CompletedNCT04551820
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 520 (actual)
- Sponsor
- Intuitive Surgical · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Regular Hours | The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays. |
| PROCEDURE | After Hours | The after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday. |
| DEVICE | Robotic-assisted Cholecystectomy | With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care. |
Timeline
- Start date
- 2020-08-05
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2020-09-16
- Last updated
- 2021-11-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04551820. Inclusion in this directory is not an endorsement.