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

Cholecystitis Clinical Trial

Official title:

Evolution of Robotic Cholecystectomy; the U.C. Davis Experience.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059745
• Other study ID #: 237231
• Status: Completed
• Start date: June 2004
• Est. completion date: March 3, 2017

Study information

• Verified date: June 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients that have undergone robotic assisted laparoscopic cholecystectomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Cholecystectomy
Single Port and Multi-Port approaches trans-laparoscopic approaches with or without the use of the daVinci Surgical Robotic System.

Locations

Country	Name	City	State
United States	University of California Davis Health System	Sacramento	California
United States	Univesity of California Davis Health System	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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