CholecystectomySPARCNCT04551820

Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

An observational study of Cholecystectomy, run by Intuitive Surgical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cholecystectomy
What is being tested?: Regular Hours, After Hours and Robotic-assisted Cholecystectomy
Type of treatment: Medical device, Surgery or procedure
How many people: 505 participants
Where: 1 siteUnited States
Study dates: 5 Aug 2020to 30 Sep 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Study population: Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.

Who may be able to join

Subject between 18 and 80 years of age at the time of surgery.
Subject underwent a robotic-assisted cholecystectomy during the study time period.

Who cannot join

Cholecystectomy was performed as a secondary procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

St. David's Medical Center
Austin, Texas, 78758

Other trials in United States

About this study

Official title: SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

Read the detailed description

The study is a retrospective multi-center chart review study of short-term patient outcomes through 30 days after robotic-assisted cholecystectomies performed during regular hours and after-hours. 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, and the hospital length of stay will be collected as secondary outcomes.

Conditions: Cholecystectomy
Being tested: Regular Hours, After Hours, Robotic-assisted Cholecystectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regular HoursProcedure or surgery
The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.
After HoursProcedure or surgery
The after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday.
Robotic-assisted CholecystectomyDevice
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 groups in NCT04551820
Study group	Role	What they receive
Regular Hours		These subjects have undergone a cholecystectomy during regular hours at the Institution. Receives: Procedure: Regular Hours; Device: Robotic-assisted Cholecystectomy
After Hours		These subjects have undergone a cholecystectomy during after hours at the Institution. Receives: Procedure: After Hours; Device: Robotic-assisted Cholecystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Cholecystectomy Converted 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 day follow-up period
Re-admissions
Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period
Measured: After discharge from the hospital post-procedure through the 30 day follow-up period
Re-operations
Re-operations related to the cholecystectomy through the 30 day follow-up period
Measured: After the procedure but prior to discharge, through the 30 day follow-up period

Secondary outcomes (3)

Operative Time
Operative time, defined as first incision to closure of the incision
Measured: Intra-operative
Use of Intra-operative Imaging
The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
Measured: Intra-operative
Length of Hospital Stay (LOS)
How long the patient was admitted to the hospital
Measured: From admission to discharge, up to approximately one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 202030 Sep 2021

First posted16 Sep 2020
Study start5 Aug 2020
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Case only
Time perspective: Retrospective
Enrolment: 505 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04551820
Sponsor's protocol ID: ISI-AHC-2020
Acronym: SPARC
Status last verified: Jul 2026
First submitted: 5 Aug 2020
Last updated: 9 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Choudhry V, Patel YK, McIntosh BB, Badrudduja M, Jandali M, Vijan S, Brown K. Retrospective multi-center study of robotic-assisted cholecystectomy: after-hours surgery and business-hours surgery outcomes. J Robot Surg. 2024 Jan 20;18(1):48. doi: 10.1007/s11701-023-01765-x.
PubMed 38244145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Colorectal Adenoma, Cholecystectomy

All Cholecystectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
ClinicalTrials.gov ID: NCT04551820
Acronym / sponsor ID: SPARC / ISI-AHC-2020
Conditions: Cholecystectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 505 participants (actual)
Lead sponsor: Intuitive SurgicalIndustry (pharma, biotech, devices)
Study start: 5 Aug 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 9 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Regular Hours	–	Procedure: Regular Hours, Device: Robotic-assisted CholecystectomyThese subjects have undergone a cholecystectomy during regular hours at the Institution.
After Hours	–	Procedure: After Hours, Device: Robotic-assisted CholecystectomyThese subjects have undergone a cholecystectomy during after hours at the Institution.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.

Key inclusion criteria (2 listed)

Subject between 18 and 80 years of age at the time of surgery.
Subject underwent a robotic-assisted cholecystectomy during the study time period.

Key exclusion criteria (1 listed)

Cholecystectomy was performed as a secondary procedure.

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
Regular HoursThe regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.	Procedure or surgery	Regular Hours
After HoursThe after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday.	Procedure or surgery	After Hours
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.	Device	After Hours, Regular Hours

Primary outcome

Number of Participants With Cholecystectomy Converted 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 day 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 day follow-up period
Re-admissions to the hospital related to the cholecystectomy through the 30 day 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 the 30 day follow-up period

3 secondary outcomes

Operative Time
Time frame: Intra-operative
Use of Intra-operative Imaging
Time frame: Intra-operative
Length of Hospital Stay (LOS)
Time frame: From admission to discharge, up to approximately one week

Results and safety

Results posted to the registry on 9 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regular Hours	336	336
After Hours	169	169

Primary outcome: Number of Participants With Cholecystectomy Converted to Open

Time frame: Intra-operative. Count of participants. Unit: Participants

Measure	Business Hours n = 336	After Hours n = 169
Value	4	0

Primary outcome: Number of Adverse Events

Time frame: Intra-operative through the 30 day follow-up period. Number. Unit: number of events

Measure	Business Hours n = 336	After Hours n = 169
Value	19	10

Primary outcome: Re-admissions

Time frame: After discharge from the hospital post-procedure through the 30 day follow-up period. Count of participants. Unit: Participants

Measure	After Hours n = 169	Business Hours n = 336
Value	5	12

Primary outcome: Re-operations

Time frame: After the procedure but prior to discharge, through the 30 day follow-up period. Count of participants. Unit: Participants

Measure	After Hours n = 169	Business Hours n = 336
Value	4	4

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Intra-procedure until the 1st follow-up visit through 30 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Business Hours	0 of 336 (0%)	18 of 336 (5.4%)	0 of 336
After Hours	0 of 169 (0%)	9 of 169 (5.3%)	0 of 169

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38244145Choudhry V, Patel YK, McIntosh BB, Badrudduja M, Jandali M, Vijan S, Brown K. Retrospective multi-center study of robotic-assisted cholecystectomy: after-hours surgery and business-hours surgery outcomes. J Robot Surg. 2024 Jan 20;18(1):48. doi: 10.1007/s11701-023-01765-x.
Individual participant dataSharing planned: No

Related trials for Cholecystectomy

Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Colorectal Adenoma, Cholecystectomy

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cholecystectomy, run by Intuitive Surgical at 1 site 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 2 inclusion and 1 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Cholecystectomy Converted 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?

On the ClinicalTrials.gov record for NCT04551820, which also lists 1 linked publication.

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 9 Sep 2026.