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

Completed

• Conditions: Cholelithiasis; Cholecystitis
• Interventions: Procedure: Cholecystectomy

• Registration Number: NCT03059745
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients that have undergone robotic assisted laparoscopic cholecystectomy

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholecystitis	Cholecystectomy	Patients consented for robotic assisted cholecystectomy evaluated in study.

Primary Outcome Measures

Name	Time	Method
Comparing hernia rates between multi-port verses single port approaches.	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).

Trial Locations

Locations (2)

University of California Davis Health System; 🇺🇸 Sacramento, California, United States

Univesity of California Davis Health System; 🇺🇸 Sacramento, California, United States