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Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03059745
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : June 27, 2018
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Comparing the use of surgical robotics during a Cholecystectomy, comparing different platforms and approaches (multi port verses single port).

Condition or disease Intervention/treatment
Cholecystitis Cholelithiasis Procedure: Cholecystectomy

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Evolution of Robotic Cholecystectomy; the U.C. Davis Experience.
Study Start Date : June 2004
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Group/Cohort Intervention/treatment
Patients consented for robotic assisted cholecystectomy evaluated in study.
Procedure: Cholecystectomy
Single Port and Multi-Port approaches trans-laparoscopic approaches with or without the use of the daVinci Surgical Robotic System.
Other Name: daVinci Surgical Robotic System

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients which have undergone a robotic assisted laparoscopic cholecystectomy

Inclusion Criteria:

  • Patients that have undergone robotic assisted laparoscopic cholecystectomy

Exclusion Criteria:

  • Patients under the age of 18, or not choosing to have surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03059745

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Contact: Tamas Vidovszky, MD 916-734-7291

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United States, California
University of California Davis Health System Recruiting
Sacramento, California, United States, 95330
Contact: Tamas Vidovszky, MD    916-734-7291   
Contact: William Smith, BS, CCRP    916-734-7820   
Univesity of California Davis Health System Completed
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Tamas Vidovszky, MD University of California, Davis

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Responsible Party: University of California, Davis Identifier: NCT03059745     History of Changes
Other Study ID Numbers: 237231
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:

Additional relevant MeSH terms:
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Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical