Validating an Inexpensive Practice Model for Microsurgical Skills Training

NCT04093063 | Completed

• 1 other identifier: STUDY00001491
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, prospective, randomized, controlled intervention trial to validate an inexpensive practice model for acquisition of microsurgical skills. Following a pre-assessment microsurgical skills task, participants were randomized to either an intervention group to build a micro-stellated icosahedron, or to a control group with no specific task assigned. A post-assessment microsurgical skills task was given to all participants after two weeks. Videos of pre- and post-assessments were masked and independently rated by two ophthalmologists using Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) scoring criteria. Analyses were done to determine improvement in time required to complete tasks and in scores between pre- and post- assessments.

Conditions

Microsurgery

Keywords

microsurgery; ophthalmology; medical education; surgical skills; surgical practice

Outcome Measures

Primary Outcomes (4)

• Change in Objective Structure Assessment of Technical Skill (OSATS) scores for passing a needle.

  The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which grades the following four criteria with a score from 1 (minimum) to 5 (maximum): Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique. Therefore, by adding the grades for each of the four criteria, the total score for passing the needle (Pass: Total) had a minimum score of 4 and a maximum possible score of 20. Higher values represent better outcomes. Both raters assigned scores for the participants' attempts at passing the needle through the incision in each video. The scores from the two raters were added. The sum of the scores were used to determine whether there was change in scores for each participant between pre-assessment and post-assessment videos. Higher scores represent a better outcome.

  Two weeks

• Change in Objective Structure Assessment of Technical Skill (OSATS) scores for making a microsurgical tie.

  The raters used the Video-based Modified Objective Structure Assessment of Technical Skill (OSATS) Scoring Criteria, which grades the following four criteria with a score from 1 (minimum) to 5 (maximum): Economy of Movement, Confidence of Movement, Respect for Materials, and Precision of Operative Technique. Therefore, by adding the grades for each of the four criteria, the total score for making a microsurgical tie (Tie: Total) had a minimum score of 4 and a maximum possible score of 20. Higher values represent better outcomes. Both raters assigned scores for the participants' attempts at making a microsurgical tie in each video. The scores from the two raters were added. The sum of the scores were used to determine whether there was change in scores for each participant between pre-assessment and post-assessment videos. Higher scores represent a better outcome.

  Two weeks

• Change in time required to pass a needle.

  The time (in seconds) each subject took to pass the needle was measured from the time subject started manipulating the needle holder and toothed forceps to the time the subject began tying maneuvers. The time (in seconds) was used to determine whether there was change in the amount of time each subject required to pass the needle between pre-assessment and post-assessment videos. Lower values represent better outcomes.

  Two weeks

• Change in time required to complete microsurgical tie.

  The time (in seconds) each subject took to attempt tying a microsurgical tie was measured from the time the subject started manipulations for tying to the time the subject completed the microsurgical tie. The time(in seconds) was used to determine whether there was change in the amount of time each subject required to make a microsurgical tie between pre-assessment and post-assessment videos. Lower values represent better outcomes.

  Two weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Micro-stellated Icosahedron

Control Group

NO INTERVENTION

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.

Interventions

Micro-stellated Icosahedron OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old or older.
• No prior microsurgical experience.

You may not qualify if:

• Prior microsurgical experience.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Jacobs School of Medicine and Biomedical Sciences

Buffalo, New York, 14203, United States

Location

Related Publications (15)

• 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.

  PMID: 17596849 BACKGROUND

• 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.

  PMID: 24797848 BACKGROUND

• 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.

  PMID: 15383395 BACKGROUND

• 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.

  PMID: 19091411 BACKGROUND

• 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.

  PMID: 16181283 BACKGROUND

• 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.

  PMID: 24495474 BACKGROUND

• 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.

  PMID: 26486033 BACKGROUND

• 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.

  PMID: 24158838 BACKGROUND

• 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.

  PMID: 26049832 BACKGROUND

• 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.

  PMID: 29021716 BACKGROUND

• 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.

  PMID: 23796766 BACKGROUND

• 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.

  PMID: 18839484 BACKGROUND

• 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.

  PMID: 15778595 BACKGROUND

• 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.

  PMID: 11757067 BACKGROUND

• 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.

  PMID: 35094230 DERIVED

Study Officials

• Sangita P Patel, MD, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In order to judge the effectiveness of intervention, participants in the intervention and control groups will perform a microsuturing task at the beginning and at the end of the study to grade surgical skills. Before each grading session, subjects will watch video instructions on how to perform microsurgical suturing. The subjects' microsurgical manipulations will be video-recorded. The video-recordings will be rated by 2 ophthalmologists, including the main investigator, masked to the identity of the subject (intervention vs control) and time of recording (either before or after intervention). Videos were muted, and subjects were instructed to wear gloves in order to ensure anonymity.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a single-center, prospective, randomized, controlled trial. After obtaining consent, recruited participants were asked to perform a microsurgical task. Their attempt was video-recorded for a pre-assessment. After completion of the video-recorded pre-assessment, participants were randomized to either the intervention or the non-intervention control group by flip of a coin. Subjects in the intervention group were tasked to build a micro-stellated icosahedron using a detailed instruction manual. Subjects in the control group had no specific task for two weeks. 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.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 17, 2019
• Study Start: June 30, 2017
• Primary Completion: July 23, 2018
• Study Completion: July 23, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)