Single Site Robotic Cholecystectomy in Non Selected Patients

Completed

• Conditions: Cholelithiasis
• Interventions: Procedure: Single site robotic chole; Device: da Vinci Si Surgical System

• Registration Number: NCT01855308
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-16
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• presence of symptomatic gallstones

Exclusion Criteria

• significant previous open abdominal surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single site robotic chole	Single site robotic chole	Cholecystectomy performed through a single incision with the robot.
Single site robotic chole	da Vinci Si Surgical System	Cholecystectomy performed through a single incision with the robot.

Primary Outcome Measures

Name	Time	Method
Completion of procedure by SSRC	At time of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States