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Completed

NCT Number: NCT04888117

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Robotic-assisted Cholecystectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Health-South Florida, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Operative time

    Time frame: Intra-operative

    Operative time, defined as first incision to closure of the incision

  2. Use of intra-operative imaging

    Time frame: Intra-operative

    The rate of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography

  3. Length of hospital stay

    Time frame: From admission to discharge, up to approximately one week

    How long the patient was admitted to the hospital

  4. Biliary anatomy identification

    Time frame: Intra-operative

    Ability for surgeons to identify biliary anatomy and incidence of abnormal biliary anatomy intra-operatively

  5. 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

  6. 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

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 17, 2021
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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