Condition category
Surgery
Date applied
17/09/2019
Date assigned
13/11/2019
Last edited
05/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Minimally invasive surgery (keyhole surgery) traditionally uses the laparoscopic technique. Laparoscopic skills are difficult to acquire and take years of practice for junior surgeons to go through the learning curve to be able to perform operations safely. More recently, the robotic technique is being used for operations, which may be easier and quicker for junior surgeons to learn basic surgical skills. The aim of this study is to compare the ability of junior surgeons and medical students to perform basic surgical skills after one day's training on either the laparoscopic or robotic simulator.

Who can participate?
Junior surgical trainees and medical students

What does the study involve?
Each participant spends two days at The Newcastle Surgical Training Centre. They are randomly allocated to either the laparoscopic or robotic group. Each participant spends 6 hours training on the laparoscopic or robotic simulator. The following day they perform three different operations on cadaveric specimens. These involve surgical skills such as suturing and careful handling of tissue. The operating is recorded and timed. Two consultant surgeons then score the anonymised participant using video analysis. They are given a global rating scale score for each procedure and the number of suturing errors is recorded.

What are the possible benefits and risks of participating?
The students and trainees who take part will gain 2 days of practice in minimally invasive surgical skills. This is very sought after amongst those interested in a career in surgery and usually requires a high fee payment for a surgical skills course. All participants will benefit substantially. Those in the laparoscopic group will benefit from training in a skill used by their team and them on a daily basis. Those in the robotic group will have the experience of this new technique, which is extremely unlikely that they would otherwise have access to this in their usual training facilities. There are no risks of participating.

Where is the study run from?
Newcastle Surgical Training Centre (UK)

When is the study starting and how long is it expected to run for?
January 2019 to June 2019

Who is funding the study?
Intuitive Foundation (USA)

Who is the main contact?
Prof. Long Jiao
l.jiao@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Long Jiao

ORCID ID

Contact details

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)2033131000
l.jiao@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

LJ006

Study information

Scientific title

Shortening surgical training through robotics: a randomised controlled trial of laparoscopic versus robotic surgical learning curves

Acronym

Study hypothesis

To determine whether there are any differences in surgical skills between laparoscopic and robotic operating on cadaveric specimens after simulation training for both surgical trainees and medical students.

Ethics approval

The Newcastle Surgical Training Centre is licensed to train students on human cadavers (Human Tissue Act 2004, Licensing no: 12148). Ethics approval was not required as there are no patients involved in the trial.

Study design

Randomised parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available

Condition

Surgical training

Intervention

Surgical trainees from the North-West Thames London Deanery and the North-East Deanery in the UK, as well as medical students from Imperial College London and from Newcastle University, will be invited to participate. Each participant will spend two days at The Newcastle Surgical Training Centre. The participants will be invited to the centre and blinded to their group until the training day. Eligible participants will be computer randomised in a 1:1 ratio between laparoscopic and robotic training. Both groups will receive either 6 hours robotic or laparoscopic simulation and box-training followed by 2 hours recorded cadaveric operating (three different operations) the following day. These involve surgical skills such as suturing and careful handling of tissue. The operating will be recorded and timed. Two consultant surgeons will then score the anonymised participant using video analysis. they will be given a global rating scale score for each procedure and the number of suturing errors will be recorded.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Global rating score (maximum points 30) for each operative task

Secondary outcome measures

1. Time taken for each task (minutes) measured after each operative task
2. Number of suturing errors for each operative task, measured after each operative task
3. Number of loops created with continuous suture closure of gastrostomy (cohort 1), measured after closure of gastrostomy
4. Number of completed sutures in 40 minutes (cohort 2), measured after completion of operative task
5. Surgeon comfort following all procedures, measured on a scale of 1-5 after completion of operative tasks

Overall trial start date

01/01/2019

Overall trial end date

01/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Surgical trainees (ST):
1.1. UK surgical trainee
1.2. Knowledge of anatomy and steps of cholecystectomy
2. Medical students (MS):
2.1. UK medical student year 3-5

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Surgical trainees (ST):
1.1. Surgical trainee for more than 4 years
1.2. Performed >5 laparoscopic or robotic cholecystectomies as the primary surgeon
2. Medical students (MS):
2.1. Previous assisting in minimally invasive surgery

Recruitment start date

01/03/2019

Recruitment end date

01/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle Surgical Training Centre
NE7 7DN
United Kingdom

Sponsor information

Organisation

The Cromwell Hospital

Sponsor details

London Robotic HPB Centre
164-178 Cromwell Road
Kensington
London
SW5 0TU
United Kingdom
+44 (0)2074605700
umeer.waheed@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.bupacromwellhospital.com

Funders

Funder type

Charity

Funder name

Intuitive Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to publish the results in a high-impact peer-reviewed international surgical journal and to present the results of the study at international surgical conferences. They plan to submit for publication at the end of 2019.

IPD sharing statement
The datasets generated and analysed will be available upon request from Tamara Gall (tamara.gall1@nhs.net). The data will be available from June 2019 for a 12-month period after which it will be deleted. The data will be stored on a password-protected NHS computer. The data will only be shared with a high impact peer-reviewed journal if requested during the review process. Consent was obtained for data collection by all participants, all data is anonymised with participants recorded as a number with no personal identification.

Intention to publish date

01/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/12/2019: Uploaded protocol (not peer reviewed). 13/11/2019: Trial's existence confirmed by funder.