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NCT03380572 Clinical Trial

Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

Cholecystitis Clinical Trial

Official title:
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03380572
Other study ID # SenhanceChole
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2017
Est. completion date January 1, 2018

Study information
Verified date May 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 1, 2018
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Senhance Assisted Cholecystectomy
Cholecystectomy performed using Senhance surgical robotic system
Procedure:
• Laparoscopic Cholecystectomy
Standard laparoscopic cholecystectomy

Locations
Country Name City State
United Kingdom Imperial College NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative Time 1 day
Secondary Morbidity Data 30 days
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