Single Site Robotic Cholecystectomy in Non Selected Patients (SSRC)

September 22, 2017 updated by: University of California, Davis
This is a study of new technology to allow gallbladder removal through a single small surgical incision. A surgical robot is utilized to help navigate the small space. In this study, patient characteristics are broad to assess how applicable the procedure is to everyone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who are referred to the surgery program with non-emergency gallbladder disease, for which cholecystectomy is indicated, will be given the opportunity to participate. Referred patients typically come from the primary care setting. The demographic composition of the study population will depend in the patient referred to the program.

Description

Inclusion Criteria:

  • presence of symptomatic gallstones

Exclusion Criteria:

  • significant previous open abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single site robotic chole
Cholecystectomy performed through a single incision with the robot.
Procedure: Single site robotic chole
Cholecystectomy
Device: da Vinci Si Surgical System
minimally invasive robotic surgical system designed to facilitate complex procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of procedure by SSRC
Time Frame: At time of surgery
At time of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events to study participants (e.g. bile duct injury, hemorrhage)
Time Frame: At time of procedure and in clinic up to 30 days after surgery
At time of procedure and in clinic up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Mohamed R Ali, MD, UC Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307021 (Other Identifier: UC Davis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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