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

Imperial College London

Status: Completed

Conditions: Cholecystitis; Biliary Colic

Treatments: Device: Senhance Assisted Cholecystectomy; Procedure: Laparoscopic Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03380572

SenhanceChole

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Senhance Cholecystectomy

Experimental group

Description:

Cholecystectomy operation performed using Senhance robotic system

Treatment:

Device: Senhance Assisted Cholecystectomy

Laparoscopic Cholecystectomy

Active Comparator group

Description:

Cholecystectomy operation performed using standard laparoscopic instruments

Treatment:

Procedure: Laparoscopic Cholecystectomy