Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy

Study Overview
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Brief Summary
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The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.

Detailed Description
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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.

Official Title
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COMPlex Cholecystectomy Trial (COMPaCT): A Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy

Conditions
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Laparoscopic Cholecystectomy, Robotic-assisted Cholecystectomy

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy
* Procedure: Robotic-assisted cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 18 and 80 years of age at the time of surgery Subject is a candidate for a cholecystectomy Subject has a diagnosis of acute cholecystitis and is being admitted through the Emergency Room (ER) Exclusion Criteria: A single port (single site or single incision procedure) cholecystectomy will be performed Subject will undergo a concomitant procedure Subject is contraindicated for surgery or a minimally invasive approach Subject has a known bleeding or clotting disorder that is not able to be controlled during surgery Pregnant or suspect pregnant Subject is mentally handicapped or has a psychological disorder or severe systematic illness that would preclude compliance with the study requirements or ability to provide informed consent Subject belonging to other vulnerable population, e.g. prisoner or ward of the state Subject is unable to comply with the follow-up visit schedule Subject is currently participating in another research study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic cholecystectomy<br>Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy. | Procedure: Laparoscopic cholecystectomy<br>* 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.<br>|
| Robotic-assisted cholecystectomy<br>Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy. | Procedure: 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 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 | 

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 intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography | 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 |