Do medical students learn laparoscopic (keyhole) surgery skills more quickly when they train using a robotic camera holder rather than a human camera holder?
| ISRCTN | ISRCTN83733979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83733979 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/03/2019
- Registration date
- 08/08/2019
- Last edited
- 01/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Guy's Campus
King's College London
London
SE1 1UL
United Kingdom
 ORCID ID |
0000-0002-5289-8890 |
|---|---|
| Phone | 07305294774 |
| mohammad.amin@kcl.ac.uk |
Scientific
MRC Centre for Transplantation
King’s College London
London
SE1 9RT
United Kingdom
| Phone | +44 (0) 20 7188 5906 |
|---|---|
| kamran.ahmed@kcl.ac.uk |
Scientific
Department of Urology
King’s College Hospital
London
SE5 9RS
United Kingdom
| jonathan.makanjuola@nhs.net |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study acronym | ROBLAP |
| Study objectives | The Robotic Arm will make the learning curve steeper or remain the same compared with conventional methods. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeHand laparoscopic camera holder |
| Primary outcome measure | Time taken to complete the training tasks measured using a stopwatch |
| Secondary outcome measures | N/A |
| Overall study start date | 01/12/2018 |
| Completion date | 28/06/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Medical student 2. No previous laparoscopic training |
| Key exclusion criteria | 1. Previous laparoscopic experience 2. Unable to commit to course 3. Consent not given |
| Date of first enrolment | 27/02/2019 |
| Date of final enrolment | 17/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE1 9RT
United Kingdom
Sponsor information
University/education
Guy's Campus
King's College London
London
SE1 1UL
England
United Kingdom
| Phone | 073052974774 |
|---|---|
| jonathan.makanjuola@nhs.net | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 12/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2020 | 01/09/2020 | Yes | No |
Editorial Notes
01/09/2020: Publication reference and total final enrolment number added.
12/06/2020: Publication and dissemination plan updated, intention to publish date changed from 01/02/2020 to 12/06/2020.
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
