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

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).

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Cholelithiasis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95330
      • University of California Davis Health System
    • Sacramento, California, United States, 95817
      • Univesity of California Davis Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients which have undergone a robotic assisted laparoscopic cholecystectomy

Description

Inclusion Criteria:

• Patients that have undergone robotic assisted laparoscopic cholecystectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cholecystitis; 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 Names: daVinci Surgical Robotic System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	June 2004 through May 2015

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Tamas Vidovszky, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (ACTUAL): March 3, 2017
• Study Completion (ACTUAL): March 3, 2017

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Cholecystitis; Cholelithiasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholecystitis; Acalculous Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 237231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO