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OpenTrials
Completed

NCT Number: NCT03380572

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

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.

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Key information

Conditions

Biliary Colic Biliary Tract Diseases Cholecystitis Digestive System Diseases Gallbladder Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College NHS Trust

London, W2 1NY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Senhance Assisted Cholecystectomy

Device

Cholecystectomy performed using Senhance surgical robotic system

Laparoscopic cholecystectomy

Procedure

Standard laparoscopic cholecystectomy

Primary outcomes

  1. Operative Time

    Time frame: 1 day

Secondary outcomes

  1. Morbidity Data

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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