The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.
This is a multi-center cohort study, evaluating short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies. 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, the hospital length of stay, and pain and QOL scores will be collected as secondary outcomes.
Study Type
OBSERVATIONAL
Enrollment
186
With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the cholecystectomy according to the surgeon's standard practice.
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.
Baptist Health-South Florida
Miami, Florida, United States
Progressive Surgical Associates, Silver Cross Hospital
New Lenox, Illinois, United States
Lovelace Medical Group
Albuquerque, New Mexico, United States
St. David's Healthcare
Austin, Texas, United States
Conversion to open
The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach
Time frame: Intra-operative
Number of adverse events
Intra-operative or post-operative adverse events related to the cholecystectomy
Time frame: Intra-operative through the 30 days follow-up period
Re-admissions
Re-admissions to the hospital related to the cholecystectomy through the 30 days follow-up period
Time frame: After discharge from the hospital post-procedure through the 30 days follow-up period
Re-operations
Re-operations related to the cholecystectomy through 30 days follow-up
Time frame: After the procedure but prior to discharge, through the 30 day follow-up period
Operative time
Operative time, defined as first incision to closure of the incision
Time frame: Intra-operative
Use of intra-operative imaging
The rate of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
Time frame: Intra-operative
Length of hospital stay
How long the patient was admitted to the hospital
Time frame: From admission to discharge, up to approximately one week
Biliary anatomy identification
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Ability for surgeons to identify biliary anatomy and incidence of abnormal biliary anatomy intra-operatively
Time frame: Intra-operative
Change in pain score assessed by the PROMIS 3a from baseline to 14 days
Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain
Time frame: 14 days
Change in pain score assessed by the PROMIS 3a from baseline to 30 days
Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain
Time frame: 30 days
Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 14 days
Quality of life using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Time frame: 14 days
Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 30 days
Quality of life using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Time frame: 30 days