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

Not Applicable

Completed

• Conditions: Biliary Colic; Cholecystitis
• Interventions: Procedure: Laparoscopic Cholecystectomy; Device: Senhance Assisted Cholecystectomy

• Registration Number: NCT03380572
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-10
• Primary Completion: 2017-12-01
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Study Completion: 2018-01-01
• Results First Submitted: 2019-02-19
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-12
• Last Update Submitted: 2019-05-14
• Results First Posted: 2019-05-15
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs

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Exclusion Criteria

Patients unable tor unwilling to consent BMI >40

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Cholecystectomy	Laparoscopic Cholecystectomy	Cholecystectomy operation performed using standard laparoscopic instruments
Senhance Cholecystectomy	Senhance Assisted Cholecystectomy	Cholecystectomy operation performed using Senhance robotic system

Primary Outcome Measures

Name	Time	Method
Operative Time	1 day

Secondary Outcome Measures

Name	Time	Method
Morbidity Data	30 days

Trial Locations

Locations (1)

Imperial College NHS Trust; 🇬🇧 London, United Kingdom