Plain English Summary
Background and study aims
In keyhole (laparoscopic) surgery, the aim is to avoid making large openings in a patient's body. The surgeons insert a camera and thin tools into small holes to view the inside of the patient's body and perform the surgery. The aim of this research is to find out whether trainee surgeons can perform keyhole (laparoscopic) surgery techniques more quickly if a robot holds the camera rather than a human. The robotic holder might provide a more steady camera image.
Who can participate?
Trainee surgeons who are following the European School of Urology's training curriculum, European training in Basic Laparoscopic Urological Skills (E-BLUS). Students with previous experience of laparoscopic skills will be excluded from the study.
What does the study involve?
Trainees will be randomly allocated to the robot or human camera holder and will carry out the practice surgery tasks in a simulated set-up. The time taken to complete the tasks will be recorded.
What are the possible benefits and risks of participating?
Participants will benefit from this trial in improving their keyhole surgery skills. They may experience stress and fatigue due to the demands of surgical training.
Where is the study run from?
The trial will take place at the Sherman Education Centre, Guy’s Hospital, London.
When is the study starting and how long is it expected to run for?
December 2018 to June 2019
Who is funding the study?
FreeHand Surgeon (UK), the maker of the Freehand robotic holder system.
Who is the main contact?
Ali Amin
ali217@live.co.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Mohammad Amin
ORCID ID
http://orcid.org/0000-0002-5289-8890
Contact details
Guy's Campus
King's College London
London
SE1 1UL
United Kingdom
07305294774
mohammad.amin@kcl.ac.uk
Type
Scientific
Additional contact
Dr Kamran Ahmed
ORCID ID
Contact details
MRC Centre for Transplantation
King’s College London
London
SE1 9RT
United Kingdom
+44 (0) 20 7188 5906
kamran.ahmed@kcl.ac.uk
Type
Scientific
Additional contact
Ms Jonathan Makanjuola
ORCID ID
Contact details
Department of Urology
King’s College Hospital
London
SE5 9RS
United Kingdom
-
jonathan.makanjuola@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of FreeHand camera holder on the learning curve for basic laparoscopic skills using the European training in basic laparoscopic urological skills (E-BLUS) validated curriculum
Acronym
ROBLAP
Study hypothesis
The Robotic Arm will make the learning curve steeper or remain the same compared with conventional methods.
Ethics approval
Approved 27/02/2019, BDM Research Ethics Panel (Franklin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Rd, London SE1 9NH; +44 207 848 4020; rec@kcl.ac.uk) ref: LRU-18/19-10406
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Surgical education
Intervention
Participants will be recruited on a voluntary basis. An open invitation will be sent out to medical students at King’s College London. This invitation will be issued via GKT Medical School Association newsletters, Facebook group pages e.g. KCL Surgical and KCL Urological societies, and word of mouth. Students will have to sign up via an online form. Students with previous experience of laparoscopic skills will be excluded from the study.
Two cohorts will be created via randomization: Control (conventional human assistant) and Intervention (FreeArm robotic laparoscopic holder). Each cohort will have 20 students. They will complete the four trials of the EBLUS curriculum: peg transfer, cutting a circle, needle guidance, laparoscopic suturing.
After enrollment participants are invited to an orientation session to help them understand the basics of keyhole surgery and equipment. Inductions sessions are 2 hours in length. After this participants are invited to attend training sessions at our simulation laboratory where they will conduct basic keyhole surgery tasks on simulators. Training consists of 10 sessions with each session lasting between 1-3 hours depending on how long they take to complete the tasks. Both cohorts are are assessed by the time it takes for them to successfully complete the task; this is done by a stopwatch. Participants from the two cohorts are free to attend training sessions as and when it suits them.
Intervention type
Device
Phase
Not Applicable
Drug names
FreeHand laparoscopic camera holder
Primary outcome measure
Time taken to complete the training tasks measured using a stopwatch
Secondary outcome measures
N/A
Overall trial start date
01/12/2018
Overall trial end date
28/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Medical student
2. No previous laparoscopic training
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
40
Total final enrolment
40
Participant exclusion criteria
1. Previous laparoscopic experience
2. Unable to commit to course
3. Consent not given
Recruitment start date
27/02/2019
Recruitment end date
17/06/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
Guy's Campus
King's College London
London
SE1 1UL
United Kingdom
073052974774
jonathan.makanjuola@nhs.net
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
FreeHand Surgeon
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers intend to publish the findings of the trial in a high impact journal.
Updated 12/06/2020:
Results published in a peer-reviewed journal and presented at international conferences with endoscopic and urological focuses. Participants will be directed for online viewing of the published article. Summary of research methods and results were forwarded to FreeHand Surgical (Guildford, United Kingdom).
IPD sharing statement:
Consent has been obtained from participants to store and analyze anonymous data. Raw data will be stored with trial organisers on secure systems and can be available on request. Ethical approval does allow for the distribution of raw data. Processed data will be available via publication.
Intention to publish date
12/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32851466/ (added 01/09/2020)