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

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Brief Title

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

Official Title

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

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 Type

Interventional

Primary Outcome

Operative Time

Secondary Outcome

 Morbidity Data

Condition

Biliary Colic

Intervention

Senhance Assisted Cholecystectomy

Study Arms / Comparison Groups

 Senhance Cholecystectomy
Description:  Cholecystectomy operation performed using Senhance robotic system

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

40

Start Date

February 10, 2017

Completion Date

January 1, 2018

Primary Completion Date

December 1, 2017

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sanjay Purkayastha, MD, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT03380572

Organization ID

SenhanceChole

Responsible Party

Principal Investigator

Study Sponsor

Imperial College London

Study Sponsor

Sanjay Purkayastha, MD, Principal Investigator, Imperial College London

Verification Date

May 2019