Clinical trial NCT04888117: Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
Official title: COMPlex Cholecystectomy Trial (COMPaCT): A Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Cholecystectomy
Robotic-assisted Cholecystectomy
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is between 18 and 80 years of age at the time of surgery
2. Subject is a candidate for a cholecystectomy
3. Subject has a diagnosis of acute cholecystitis and is being admitted through the Emergency Room (ER)

Exclusion Criteria:

1. A single port (single site or single incision procedure) cholecystectomy will be performed
2. Subject will undergo a concomitant procedure
3. Subject is contraindicated for surgery or a minimally invasive approach
4. Subject has a known bleeding or clotting disorder that is not able to be controlled during surgery
5. Pregnant or suspect pregnant
6. 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
7. Subject belonging to other vulnerable population, e.g. prisoner or ward of the state
8. Subject is unable to comply with the follow-up visit schedule
9. Subject is currently participating in another research study

Primary outcomes:
measure: Conversion to open
timeFrame: Intra-operative
measure: Number of adverse events
timeFrame: Intra-operative through the 30 days follow-up period
measure: Re-admissions
timeFrame: After discharge from the hospital post-procedure through the 30 days follow-up period
measure: Re-operations
timeFrame: After the procedure but prior to discharge, through the 30 day follow-up period
Secondary outcomes:
measure: Operative time
timeFrame: Intra-operative
measure: Use of intra-operative imaging
timeFrame: Intra-operative
measure: Length of hospital stay
timeFrame: From admission to discharge, up to approximately one week
measure: Biliary anatomy identification
timeFrame: Intra-operative
measure: Change in pain score assessed by the PROMIS 3a from baseline to 14 days
timeFrame: 14 days
measure: Change in pain score assessed by the PROMIS 3a from baseline to 30 days
timeFrame: 30 days
measure: Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 14 days
timeFrame: 14 days
measure: Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health-South Florida
state: Florida
city: New Lenox
country: United States
facility: Progressive Surgical Associates, Silver Cross Hospital
state: Illinois
city: Albuquerque
country: United States
facility: Lovelace Medical Group
state: New Mexico
city: Austin
country: United States
facility: St. David's Healthcare
state: Texas
Study officials:
References: