Condition category
Surgery
Date applied
04/03/2019
Date assigned
08/08/2019
Last edited
08/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

We intend to publish the findings of our trial in a high impact journal.

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

01/02/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/08/2019: The following changes were made to the trial record: 1. The trial setting was changed from Hospitals to Other (the trial took place in University) 2. The following were added as study contacts: Dr K Ahmed, Dr J Makanjuola 26/06/2019: Trial's existence confirmed by King's College London Research Ethics Office