NCT01866436

Brief Summary

To practice independently surgeons require competency in surgical skills, encompassing a combination of technical and non-technical skills. Cognitive skills, aspects of non-technical skills, represent an integral component of surgical competency. Cognitive skills comprise factual knowledge and decision-making. Changing work patterns in the United Kingdom, as specified by the European Working Time Directive (EWTD), have had a profound impact on the delivery of surgical skills training. Surgical trainees are now increasingly removed from normal working hours in which the majority of traditional operative training and experience is gained, leading to a net reduction in trainees' operative exposure. This reduction in operative experience means that surgical competence can no longer be assured on the basis of experience alone. Although there is no educational technology that can replace the craft apprenticeship required to train a competent surgeon, reduction in training hours has led to rapid development of educational tools to augment surgical skills training outside the operating room environment. These tools tend to concentrate on technical skills performance without emphasis on cognitive skills. Trainees in today's era have grown up in a multimedia environment; multimedia is media that uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped educational resource that can supplement cognitive skills training in operative surgery. The purpose of this study was to design and develop an online multimedia educational tool in a common colorectal surgery procedure ("Anterior Resection") and determine the effectiveness of this tool in teaching and assessment of cognitive skills. Study hypothesis: Multimedia learning is equivalent to conventional teaching "Study Day" in improving scores in cognitive surgical skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

May 14, 2013

Last Update Submit

May 30, 2013

Conditions

Focus of Study: Cognitive Surgical Skill Acquisition

Keywords

Cognitive skillsMultimediaEducationColorectal surgery

Outcome Measures

Primary Outcomes (1)

  • Improvement in assessment scores following implementation of the teaching modality (Multimedia and Study day).

    All participants were assessed using a timed 30 minute online tool (sent via a hyperlink) to test cognitive skills both before and after the teaching modality. The assessment tool comprised a random assortment of 30 multiple choice and short answer questions. A similar test had been previously validated. A large bank of two hundred questions was designed to comprehensively cover cognitive skills relevant to all the procedural steps in open and laparoscopic 'anterior resection' surgery. The question content was germane to the information delivered in the multimedia tools and study day. Completed forms were stored securely on Smart Survey software. The purpose of the on-line pre-assessment test score was to establish the baseline level knowledge of all participants, prior to randomisation.

    Participants will be followed for the duration of the educational study, a period of 11 weeks

Secondary Outcomes (1)

  • The association between change in scores and level of training and acceptability of multimedia as an educational resource.

    Participants will be followed for the duration of the educational study, a period of 11 weeks

Study Arms (2)

Multimedia group

EXPERIMENTAL

The multimedia group is the interventional arm of the study

Other: Multimedia group

Study Day Group

EXPERIMENTAL

The study day group are the control arm of the study

Other: Study Day Group

Interventions

Multimedia groupOTHER

Participants are provided with unrestricted access to the online multimedia educational tools for self-directed study (during the study period)

Also known as: Anterior Resection Multimedia Educational Tools, http://www.colorectaltraining.co.uk
Multimedia group
Study Day GroupOTHER

Participants in the control arm of the study attend a conventional teaching "Study Day" involving a series of lectures on Open and Laparoscopic Anterior Resection

Study Day Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postgraduate specialist general surgical trainees at Speciality Training Year 3 (ST3) level/ Specialist Registrar (SpR) Year 1 or above

You may not qualify if:

  • Postgraduate general surgical trainees below ST3 level/ SPR Year 1
  • ALL non general surgical postgraduate trainees
  • Medical students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Surgical Oncology Unit, University of Sheffield

Sheffield, South Yorkshire, S10 2RX, United Kingdom

Location

Related Publications (6)

  • Fitzgerald JE, Caesar BC. The European Working Time Directive: a practical review for surgical trainees. Int J Surg. 2012;10(8):399-403. doi: 10.1016/j.ijsu.2012.08.007. Epub 2012 Aug 24.

    PMID: 22925631BACKGROUND

  • Moonesinghe SR, Lowery J, Shahi N, Millen A, Beard JD. Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review. BMJ. 2011 Mar 22;342:d1580. doi: 10.1136/bmj.d1580.

    PMID: 21427046BACKGROUND

  • Beard JD. Assessment of surgical competence. Br J Surg. 2007 Nov;94(11):1315-6. doi: 10.1002/bjs.6048. No abstract available.

    PMID: 17939136BACKGROUND

  • Reznick RK. Surgical simulation: a vital part of our future. Ann Surg. 2005 Nov;242(5):640-1. doi: 10.1097/01.sla.0000186270.53049.74. No abstract available.

    PMID: 16244535BACKGROUND

  • Kneebone RL. Skills training using multimedia and models. Hosp Med. 2001 Jul;62(7):428-30. doi: 10.12968/hosp.2001.62.7.1615.

    PMID: 11480133BACKGROUND

  • Shariff U, Kullar N, Haray PN, Dorudi S, Balasubramanian SP. Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial. Colorectal Dis. 2015 May;17(5):441-50. doi: 10.1111/codi.12863.

    PMID: 25495835DERIVED

Related Links

Study Officials

  • Umar Shariff, MBChB, MRCS

    University of Sheffield

    PRINCIPAL INVESTIGATOR

  • Saba Balasubramanian, PhD, FRCS

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Registrar in General Surgery

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 31, 2013

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

GB(1)