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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic cholecystectomy | Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy. |
| |
| Robotic-assisted cholecystectomy | Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy | Procedure | 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. |
| 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 days follow-up period |
| Re-admissions | Re-admissions to the hospital related to the cholecystectomy through the 30 days follow-up period | 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 | After the procedure but prior to discharge, through the 30 day follow-up period |
| 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 intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are eligible based on the inclusion/exclusion criteria may participate in the study. Approximately 100 subjects will be enrolled in each cohort (laparoscopic and robotic-assisted). In each cohort, a maximum of 50% of subjects may be enrolled with a Nassar Grade II, and a minimum of 50% of subjects with either Nassar Grade III or IV may be enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health-South Florida | Miami | Florida | 33176 | United States | ||
| Progressive Surgical Associates, Silver Cross Hospital |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Robotic-assisted cholecystectomy | Procedure | 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. |
|
| Intra-operative |
| Length of hospital stay | How long the patient was admitted to the hospital | From admission to discharge, up to approximately one week |
| Biliary anatomy identification | Ability for surgeons to identify biliary anatomy and incidence of abnormal biliary anatomy intra-operatively | 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 | 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 | 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) | 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) | 30 days |
| New Lenox |
| Illinois |
| 60451 |
| United States |
| Lovelace Medical Group | Albuquerque | New Mexico | 87102 | United States |
| St. David's Healthcare | Austin | Texas | 78701 | United States |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |