Cholecystectomy
Conditions
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.
Interventions
PROCEDURERegular Hours
The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.
PROCEDUREAfter 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.
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.
Sponsors
Intuitive Surgical
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject between 18 and 80 years of age at the time of surgery. * Subject underwent a robotic-assisted cholecystectomy during the study time period.
Exclusion criteria
* Cholecystectomy was performed as a secondary procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cholecystectomy Converted to Open | Intra-operative | The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach. |
| Number of Adverse Events | Intra-operative through the 30 day follow-up period | Intra-operative or post-operative adverse events related to the cholecystectomy |
| Re-admissions | After discharge from the hospital post-procedure through the 30 day follow-up period | Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period |
| Re-operations | After the procedure but prior to discharge, through the 30 day follow-up period | Re-operations related to the cholecystectomy through the 30 day follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intra-operative | Operative time, defined as first incision to closure of the incision |
| Use of Intra-operative Imaging | Intra-operative | The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography |
| Length of Hospital Stay (LOS) | From admission to discharge, up to approximately one week | How long the patient was admitted to the hospital |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 71 Participants |
| Race (NIH/OMB) White | 380 Participants |
| Sex: Female, Male Female | 218 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 336 | 0 / 169 |
| other Total, other adverse events | 18 / 336 | 9 / 169 |
| serious Total, serious adverse events | 0 / 336 | 0 / 169 |
Outcome results
None listed