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

May 26, 2023 updated by: Intuitive Surgical

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
    • Illinois
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • Progressive Surgical Associates, Silver Cross Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reza Gamagami, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Not yet recruiting
        • Lovelace Medical Group
        • Contact:
        • Principal Investigator:
          • Mario Leyba, MD
    • Texas
      • Austin, Texas, United States, 78701
        • Not yet recruiting
        • St. David's Healthcare
        • Contact:
        • Principal Investigator:
          • Vinnie Choudhry, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: Intra-operative
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
Time Frame: Intra-operative through the 30 days follow-up period
Intra-operative or post-operative adverse events related to the cholecystectomy
Intra-operative through the 30 days follow-up period
Re-admissions
Time Frame: After discharge from the hospital post-procedure through the 30 days follow-up period
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
Time Frame: After the procedure but prior to discharge, through the 30 day follow-up period
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
Time Frame: Intra-operative
Operative time, defined as first incision to closure of the incision
Intra-operative
Use of intra-operative imaging
Time Frame: Intra-operative
The rate of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
Intra-operative
Length of hospital stay
Time Frame: From admission to discharge, up to approximately one week
How long the patient was admitted to the hospital
From admission to discharge, up to approximately one week
Biliary anatomy identification
Time Frame: Intra-operative
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

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, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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