CholecystitisNCT03059745
Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves
An observational study of Cholecystitis and Cholelithiasis, run by University of California, Davis at 2 sites in United States.
Trial summary
Comparing the use of surgical robotics during a Cholecystectomy, comparing different platforms and approaches (multi port verses single port). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystitis, Cholelithiasis
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2004to 3 Mar 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients which have undergone a robotic assisted laparoscopic cholecystectomy
Who may be able to join
- Patients that have undergone robotic assisted laparoscopic cholecystectomy
Who cannot join
- Patients under the age of 18, or not choosing to have surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Davis Health System
Sacramento, California, 95330
Univesity of California Davis Health System
Sacramento, California, 95817
About this study
Official title: Evolution of Robotic Cholecystectomy; the U.C. Davis Experience.
Comparing the use of surgical robotics during a Cholecystectomy, comparing different platforms and approaches (multi port verses single port).
Read the detailed description
This study is a restrospective review of charts, including operating room notes as well as operating room documentation of procedures. Currently there are numerous methods considered to be the Standard of Care in the surgical treatment of Cholecystitis, or Cholelithiasis, including Open Surgery, Laparoscopic, and Robotic Assisted Laparoscopic Surgery. This study retrospectively reviews the intraoperative and post operative clinical outcomes of Laparoscopic and Robotic Assisted Surgery at U.C. Davis Medical Center to: 1) establish the role of robotics in laparoscopic surgery, and 2) to assess the learning curve by surgeons.
- Conditions
- Cholecystitis, Cholelithiasis
- Being tested
- Cholecystectomy
- Keywords
- Cholecystitis, Cholelithiasis
- Medical subject headings
- Cholecystitis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Also called daVinci Surgical Robotic System
Single Port and Multi-Port approaches trans-laparoscopic approaches with or without the use of the daVinci Surgical Robotic System.
| Study group | Role | What they receive |
|---|---|---|
| Cholecystitis | Patients consented for robotic assisted cholecystectomy evaluated in study. Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing hernia rates between multi-port verses single port approaches.
Comparing multi port and single port approaches. Patients will be followed up under the standard of care model, normal clinical follow-ups required post surgery (10 Days to 2 weeks post operative) with additional clinical visits as required to monitor post operative complications (if any).
Measured: June 2004 through May 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJun 2004
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamas Vidovszky, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059745
- Sponsor's protocol ID
- 237231
- Status last verified
- Jun 2019
- First submitted
- 27 Jan 2014
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Robotic Cholecystectomy; the U.C. Davis Experience.
- ClinicalTrials.gov ID
- NCT03059745
- Acronym / sponsor ID
- 237231
- Conditions
- Cholecystitis, Cholelithiasis
- Keywords
- Cholecystitis, Cholelithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 23 Feb 2017 (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.
Comparing the use of surgical robotics during a Cholecystectomy, comparing different platforms and approaches (multi port verses single port).
Detailed description
This study is a restrospective review of charts, including operating room notes as well as operating room documentation of procedures. Currently there are numerous methods considered to be the Standard of Care in the surgical treatment of Cholecystitis, or Cholelithiasis, including Open Surgery, Laparoscopic, and Robotic Assisted Laparoscopic Surgery. This study retrospectively reviews the intraoperative and post operative clinical outcomes of Laparoscopic and Robotic Assisted Surgery at U.C. Davis Medical Center to: 1) establish the role of robotics in laparoscopic surgery, and 2) to assess the learning curve by surgeons.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholecystitis | – | Procedure: CholecystectomyPatients consented for robotic assisted cholecystectomy evaluated in study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients which have undergone a robotic assisted laparoscopic cholecystectomy
Key inclusion criteria (1 listed)
- Patients that have undergone robotic assisted laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- Patients under the age of 18, or not choosing to have surgery.
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 |
|---|---|---|
| CholecystectomyAlso: daVinci Surgical Robotic SystemSingle Port and Multi-Port approaches trans-laparoscopic approaches with or without the use of the daVinci Surgical Robotic System. | Procedure or surgery | Cholecystitis |
Primary outcome
Comparing hernia rates between multi-port verses single port approaches.
Time frame: June 2004 through May 2015
Comparing multi port and single port approaches. Patients will be followed up under the standard of care model, normal clinical follow-ups required post surgery (10 Days to 2 weeks post operative) with additional clinical visits as required to monitor post operative complications (if any).
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 11 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Tamas Vidovszky, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis and Cholelithiasis, run by University of California, Davis at 2 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 1 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Comparing hernia rates between multi-port verses single port approaches. (time frame: June 2004 through May 2015). 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 11 Jun 2019.