Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 11, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedResults Posted
Study results publicly available
May 15, 2019
CompletedMay 21, 2019
May 1, 2019
10 months
December 11, 2017
February 19, 2019
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operative Time
1 day
Secondary Outcomes (1)
Morbidity Data
30 days
Study Arms (2)
Senhance Cholecystectomy
EXPERIMENTALCholecystectomy operation performed using Senhance robotic system
Laparoscopic Cholecystectomy
ACTIVE COMPARATORCholecystectomy operation performed using standard laparoscopic instruments
Interventions
Cholecystectomy performed using Senhance surgical robotic system
Standard laparoscopic cholecystectomy
Eligibility Criteria
You may qualify if:
- ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
You may not qualify if:
- Patients unable tor unwilling to consent BMI \>40
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College NHS Trust
London, W2 1NY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mr R Aggarwal
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Purkayastha, MD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Fellow
Study Record Dates
First Submitted
December 11, 2017
First Posted
December 21, 2017
Study Start
February 10, 2017
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
May 21, 2019
Results First Posted
May 15, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share