Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Operative Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Senhance Cholecystectomy
Cholecystectomy operation performed using Senhance robotic system
Intervention: Senhance Assisted Cholecystectomy (Device)
Laparoscopic Cholecystectomy
Cholecystectomy operation performed using standard laparoscopic instruments
Intervention: Laparoscopic Cholecystectomy (Procedure)
Outcomes
Primary Outcomes
Operative Time
Time Frame: 1 day
Secondary Outcomes
- Morbidity Data(30 days)
Investigators
Ravi Aggarwal
Clinical Research Fellow
Imperial College London