Back to resultsInitial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Primary Purpose
Biliary Colic, Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Senhance Assisted Cholecystectomy
Laparoscopic Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Colic focused on measuring Robotic Surgery
Eligibility Criteria
Inclusion Criteria:
ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
Exclusion Criteria:
Patients unable tor unwilling to consent BMI >40
Sites / Locations
- Imperial College NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Senhance Cholecystectomy
Laparoscopic Cholecystectomy
Arm Description
Cholecystectomy operation performed using Senhance robotic system
Cholecystectomy operation performed using standard laparoscopic instruments
Outcomes
Primary Outcome Measures
Operative Time
Secondary Outcome Measures
Morbidity Data
Full Information
NCT ID
NCT03380572
First Posted
December 11, 2017
Last Updated
May 14, 2019
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT03380572
Brief Title
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Official Title
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.
Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Colic, Cholecystitis
Keywords
Robotic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Senhance Cholecystectomy
Arm Type
Experimental
Arm Description
Cholecystectomy operation performed using Senhance robotic system
Arm Title
Laparoscopic Cholecystectomy
Arm Type
Active Comparator
Arm Description
Cholecystectomy operation performed using standard laparoscopic instruments
Intervention Type
Device
Intervention Name(s)
Senhance Assisted Cholecystectomy
Intervention Description
Cholecystectomy performed using Senhance surgical robotic system
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy
Intervention Description
Standard laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Operative Time
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Morbidity Data
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
Exclusion Criteria:
Patients unable tor unwilling to consent BMI >40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Purkayastha, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
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