NCT03059745

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2017

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

12.8 years

First QC Date

January 27, 2014

Last Update Submit

June 10, 2019

Conditions

CholecystitisCholelithiasis

Keywords

CholecystitisCholelithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cholecystitis

Patients consented for robotic assisted cholecystectomy evaluated in study.

Procedure: Cholecystectomy

Interventions

CholecystectomyPROCEDURE

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

Also known as: daVinci Surgical Robotic System
Cholecystitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients which have undergone a robotic assisted laparoscopic cholecystectomy

You may qualify if:

  • Patients that have undergone robotic assisted laparoscopic cholecystectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Davis Health System

Sacramento, California, 95330, United States

Location

Univesity of California Davis Health System

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

CholecystitisCholelithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Tamas Vidovszky, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

February 23, 2017

Study Start

June 1, 2004

Primary Completion

March 3, 2017

Study Completion

March 3, 2017

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)