Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

Study Overview
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Brief Summary
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A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

Detailed Description
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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.

Official Title
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SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

Conditions
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Cholecystectomy

Intervention / Treatment
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* Procedure: Regular Hours
* Procedure: After Hours
* Device: Robotic-assisted Cholecystectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regular Hours<br>These subjects have undergone a cholecystectomy during regular hours at the Institution. | Procedure: Regular Hours<br>* The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.<br>Device: Robotic-assisted Cholecystectomy<br>* 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.<br>|
| After Hours<br>These subjects have undergone a cholecystectomy during after hours at the Institution. | Procedure: After Hours<br>* 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.<br>Device: Robotic-assisted Cholecystectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to open | The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach. | Intra-operative | 
| Number of adverse events | Intra-operative or post-operative adverse events related to the cholecystectomy | Intra-operative through the 30 day follow-up period | 
| Re-admissions | Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period | After discharge from the hospital post-procedure through the 30 day follow-up period | 
| Re-operations | Re-operations related to the cholecystectomy through the 30 day follow-up period | After the procedure but prior to discharge, through the 30 day follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time, defined as first incision to closure of the incision | Intra-operative | 
| Use of intra-operative imaging | The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography | Intra-operative | 
| Length of Hospital Stay (LOS) | How long the patient was admitted to the hospital | From admission to discharge, up to approximately one week |