Laparoscopic CholecystectomyNCT04888117
Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
An observational study of Laparoscopic Cholecystectomy and Robotic-assisted Cholecystectomy, run by Intuitive Surgical at 4 sites in United States.
Trial summary
The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy, Robotic-assisted Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy and Robotic-assisted cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 186 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jun 2021to 27 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lovelace Medical Group
Albuquerque, New Mexico, 87102
St. David's Healthcare
Austin, Texas, 78701
Baptist Health-South Florida
Miami, Florida, 33176
Progressive Surgical Associates, Silver Cross Hospital
New Lenox, Illinois, 60451
About this study
Official title: 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.
Read the 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.
- Being tested
- Laparoscopic cholecystectomy, Robotic-assisted cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
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 cholecystectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy | Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy. Receives: Procedure: Laparoscopic cholecystectomy | |
| Robotic-assisted cholecystectomy | Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy. Receives: Procedure: Robotic-assisted cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to open
The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach
Measured: Intra-operative
Number of adverse events
Intra-operative or post-operative adverse events related to the cholecystectomy
Measured: 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
Measured: 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
Measured: After the procedure but prior to discharge, through the 30 day follow-up period
Secondary outcomes (8)
Operative time
Operative time, defined as first incision to closure of the incision
Measured: Intra-operative
Use of intra-operative imaging
The rate of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
Measured: Intra-operative
Length of hospital stay
How long the patient was admitted to the hospital
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start5 Jun 2021
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888117
- Sponsor's protocol ID
- COMPaCT
- Status last verified
- Jan 2025
- First submitted
- 11 May 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPlex Cholecystectomy Trial (COMPaCT): A Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
- ClinicalTrials.gov ID
- NCT04888117
- Acronym / sponsor ID
- COMPaCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy | – | Procedure: Laparoscopic cholecystectomySubject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy. |
| Robotic-assisted cholecystectomy | – | Procedure: Robotic-assisted cholecystectomySubject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyWith 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. | Procedure or surgery | Laparoscopic cholecystectomy |
| Robotic-assisted cholecystectomyWith 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. | Procedure or surgery | Robotic-assisted cholecystectomy |
Primary outcome
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
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
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
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
8 secondary outcomes
Operative time
Time frame: Intra-operative
Use of intra-operative imaging
Time frame: Intra-operative
Length of hospital stay
Time frame: From admission to discharge, up to approximately one week
Biliary anatomy identification
Time frame: Intra-operative
Change in pain score assessed by the PROMIS 3a from baseline to 14 days
Time frame: 14 days
Change in pain score assessed by the PROMIS 3a from baseline to 30 days
Time frame: 30 days
Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 14 days
Time frame: 14 days
Change in Quality of Life assessment: EQ-5D-5L (EQ) from baseline to 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Robotic-assisted Cholecystectomy, run by Intuitive Surgical at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to open (time frame: Intra-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.