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

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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy; Robotic-assisted Cholecystectomy
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy; Procedure: Robotic-assisted cholecystectomy

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.

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Health-South Florida
  • Illinois
    • New Lenox, Illinois, United States, 60451
      • Progressive Surgical Associates, Silver Cross Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Lovelace Medical Group
  • Texas
    • Austin, Texas, United States, 78701
      • St. David's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic cholecystectomy; Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy.	Procedure: Laparoscopic cholecystectomy; 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.
Robotic-assisted cholecystectomy; Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy.	Procedure: Robotic-assisted cholecystectomy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): January 27, 2025

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CoMPACT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No