Validating an Inexpensive Practice Model for Microsurgical Skills Training
NCT ID: NCT04093063
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2017-06-30
2018-07-23
Brief Summary
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Detailed Description
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Participants first watched an instructional video made by the Principal Investigator on how to pass a 9-0 nylon suture needle, and how to perform a microsurgical tie for a linear incision in a silicon baking mat using the same materials as would be provided to them for the pre- and post-assessments (Video 1). After watching the video three consecutive times, participants were tasked to pass and tie a 9-0 nylon suture in the same manner as the video recording. Their attempt at performing the microsurgical task was video-recorded for a pre-assessment with a cellphone camera focusing on the microscope field ensuring a clear view of the surgical field and the participant's instrument manipulation. Each subject wore gloves during the assessment to ensure anonymity.
After completion of the video-recorded pre-assessment, participants were randomized by flip of a coin to either the intervention group to build a micro-stellated icosahedron, or to the non-intervention control group with no assigned task. All subjects in both groups were required to return in two weeks for a second in-person meeting. At the second meeting, they were presented with the same instructional video as in the first meeting on how to pass a needle and perform a microsurgical tie. After watching the video three consecutive times, their attempt at completing a microsurgical tie was video-recorded for a post-assessment, using similar instruments and set-up as those used two weeks prior. Subjects in the intervention group were asked to return borrowed materials and their completed micro-stellated icosahedrons.
After all subjects were recruited, and their corresponding microsurgical tasks were video-recorded for pre- and post-assessments, each of the videos was edited to mute all audio in order to ensure anonymity. Each of the videos was de-identified by naming it with a random number from 1 to 42 and saved in a file folder in random order. This file folder was sent separately to two ophthalmologists, masked to the identity of the subjects (intervention vs control) and time of recording (pre- or post-assessment).
The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which scores four criteria with scores from 1 to 5: Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique.4 The raters assigned separate scores for the participant's attempt at passing the needle through the incision, and for their attempt at tying a microsurgical tie. The attempt at passing the needle (Pass: Total) had a maximum possible score of 20, and the attempt at tying a microsurgical tie (Tie: Total) had a maximum possible score of 20, making 40 the maximum possible total score for each video (Total: Pass+Tie). The time each subject took to pass the needle, and the time each subject took to attempt tying a microsurgical tie was measured in number of seconds.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
All subjects in both groups were required to return in two weeks for a second in-person meeting. At the second meeting, their attempt at completing a microsurgical task was video-recorded for a post-assessment, using similar instruments and set-up as those used two weeks prior.
OTHER
DOUBLE
Study Groups
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Intervention Group
Subjects in the intervention group were tasked with building a micro-stellated icosahedron using a detailed instruction manual. They were each provided with a dissecting microscope and necessary materials to complete the task at home at their leisure. They were given two weeks to complete the task. They were asked to return for a second in-person meeting two weeks.
Micro-stellated Icosahedron
A portable, inexpensive microsurgery training model that requires the following materials for completion. a stereoscopic dissecting microscope, two jeweler style forceps, a pair of curved-tip micro scissors , 1 meter of monofilament nylon thread, 0.5 meter of polyimide microtubule material , one 15 cm metal ruler, a scalpel blade (#15), and double-sided tape. For a microsurgically-naive subject, a total of 20 hours are required to complete this model.
Control Group
Subjects in the non-intervention control group were not given any task or any materials. They were asked to return for a second in-person meeting in two weeks.
No interventions assigned to this group
Interventions
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Micro-stellated Icosahedron
A portable, inexpensive microsurgery training model that requires the following materials for completion. a stereoscopic dissecting microscope, two jeweler style forceps, a pair of curved-tip micro scissors , 1 meter of monofilament nylon thread, 0.5 meter of polyimide microtubule material , one 15 cm metal ruler, a scalpel blade (#15), and double-sided tape. For a microsurgically-naive subject, a total of 20 hours are required to complete this model.
Eligibility Criteria
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Inclusion Criteria
* No prior microsurgical experience.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Sangita Patel
Principal Investigator
Principal Investigators
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Sangita P Patel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
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Jacobs School of Medicine and Biomedical Sciences
Buffalo, New York, United States
Countries
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References
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Chan WY, Matteucci P, Southern SJ. Validation of microsurgical models in microsurgery training and competence: a review. Microsurgery. 2007;27(5):494-9. doi: 10.1002/micr.20393.
Dumestre D, Yeung JK, Temple-Oberle C. Evidence-based microsurgical skill-acquisition series part 1: validated microsurgical models--a systematic review. J Surg Educ. 2014 May-Jun;71(3):329-38. doi: 10.1016/j.jsurg.2013.09.008. Epub 2014 Jan 4.
Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.
Ezra DG, Aggarwal R, Michaelides M, Okhravi N, Verma S, Benjamin L, Bloom P, Darzi A, Sullivan P. Skills acquisition and assessment after a microsurgical skills course for ophthalmology residents. Ophthalmology. 2009 Feb;116(2):257-62. doi: 10.1016/j.ophtha.2008.09.038. Epub 2008 Dec 16.
Benjamin L. Selection, teaching and training in ophthalmology. Clin Exp Ophthalmol. 2005 Oct;33(5):524-30. doi: 10.1111/j.1442-9071.2005.01089.x.
Belykh E, Byvaltsev V. Off-the-job microsurgical training on dry models: Siberian experience. World Neurosurg. 2014 Jul-Aug;82(1-2):20-4. doi: 10.1016/j.wneu.2014.01.018. Epub 2014 Feb 2.
White CA, Wrzosek JA, Chesnutt DA, Enyedi LB, Cabrera MT. A novel method for teaching key steps of strabismus surgery in the wet lab. J AAPOS. 2015 Oct;19(5):468-70.e1. doi: 10.1016/j.jaapos.2015.05.020.
Sikder S, Tuwairqi K, Al-Kahtani E, Myers WG, Banerjee P. Surgical simulators in cataract surgery training. Br J Ophthalmol. 2014 Feb;98(2):154-8. doi: 10.1136/bjophthalmol-2013-303700. Epub 2013 Oct 24.
Nandigam K, Soh J, Gensheimer WG, Ghazi A, Khalifa YM. Cost analysis of objective resident cataract surgery assessments. J Cataract Refract Surg. 2015 May;41(5):997-1003. doi: 10.1016/j.jcrs.2014.08.041.
McCannel CA. Continuous Curvilinear Capsulorhexis Training and Non-Rhexis Related Vitreous Loss: The Specificity of Virtual Reality Simulator Surgical Training (An American Ophthalmological Society Thesis). Trans Am Ophthalmol Soc. 2017 Aug 22;115:T2. eCollection 2017 Aug.
McCannel CA, Reed DC, Goldman DR. Ophthalmic surgery simulator training improves resident performance of capsulorhexis in the operating room. Ophthalmology. 2013 Dec;120(12):2456-2461. doi: 10.1016/j.ophtha.2013.05.003. Epub 2013 Jun 21.
Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
Rufer F, Schroder A, Erb C. White-to-white corneal diameter: normal values in healthy humans obtained with the Orbscan II topography system. Cornea. 2005 Apr;24(3):259-61. doi: 10.1097/01.ico.0000148312.01805.53.
Lannon DA, Atkins JA, Butler PE. Non-vital, prosthetic, and virtual reality models of microsurgical training. Microsurgery. 2001;21(8):389-93. doi: 10.1002/micr.21709.
Greyner-Almeida HD, Mahdavi Fard A, Chen C, Zhao J, Patel SP. A portable, low-cost practice model for microsurgical skills training. Int Ophthalmol. 2022 Aug;42(8):2323-2333. doi: 10.1007/s10792-022-02229-1. Epub 2022 Jan 29.
Other Identifiers
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STUDY00001491
Identifier Type: -
Identifier Source: org_study_id
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