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Register:	ISRCTN
Last refreshed on:	26 August 2019
Main ID:	ISRCTN47552076
Date of registration:	21/04/2016
Prospective Registration:	No
Primary sponsor:	King's College London
Public title:	Cognitive training in robotic surgery
Scientific title:	Randomised controlled trial for development & evaluation of cognitive training for robot assisted surgery (RAS)
Date of first enrolment:	01/08/2015
Target sample size:	53
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN47552076
Study type:	Interventional
Study design:	Single centre randomised controlled trial (Other)
Phase:	Not Applicable

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Nicholas Raison
Address:	MRC Centre for Transplantation King's College London, Guy's Hospital Great Maze Pond SE1 9RT London United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Medical students and doctors without any prior experience in performing robotic surgery and without independent surgical experience of any kind.
Exclusion criteria:
1. Non-medically trained participants
2. Participants unable to attend requisite training and evaluation sessions
3. Participants with prior training in robotic surgery or non technical surgical skills

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cognitive training
Surgery

Intervention(s)

All participants underwent identical initial training. This consisted of training in basic suturing training using a benchtop plastic model. Following this all participants underwent basic robotic skills training in which they completed two tasks on the DV-Trainer virtual reality simulator including a robotic suturing task. The participants were then randomly assigned to one of two groups:

1. Intervention group: Participants underwent cognition training. This consisted of mental rehearsing the steps of the procedure (robotic suturing) using a mental rehearsal script
2. Control group: Participants were shown in a video of the procedure being performed which constituted standard training

Primary Outcome(s)

1. Technical robotic surgical skill will be measured using the GEARS validated scoring system
2. Non technical skills will be measures using the NOTSS validated scoring system

Both scores will be determined by two blinded experts who will review and assess videos of the individual participant’s performances post hoc.

Secondary Outcome(s)

1. Assessing vividness of mental imagery using the Mental imagery questionnaire
2. Participant opinion, evaluated using a feedback questionnaire

Secondary ID(s)

N/A

Source(s) of Monetary Support

Vattikuti Foundation

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Biomedical Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee, King's College London, 13/10/2015, ref: LRS-15/16-1950

Results

Results available:	Yes
Date Posted:
Date Completed:	01/05/2016
URL:

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