Validating an Inexpensive Practice Model for Microsurgical Skills Training

October 19, 2020 updated by: Sangita Patel, State University of New York at Buffalo

An Inexpensive Practice Model for Microsurgical Skills Training: A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a single-center, prospective, randomized trial approved by the University at Buffalo Institutional Review Board. Medical students, residents and other interested individuals without prior microsurgery experience affiliated with the Jacobs School of Medicine and Biomedical Sciences were invited to participate. Each participant completed written informed consent.

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Jacobs School of Medicine and Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior microsurgical experience.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Objective Structure Assessment of Technical Skill (OSATS) scores for passing a needle.
Time Frame: Two weeks

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.
Time Frame: Two weeks

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.
Time Frame: Two weeks

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.
Time Frame: Two weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Sangita P Patel, MD, PhD, State University of New York at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2017

Primary Completion (Actual)

July 23, 2018

Study Completion (Actual)

July 23, 2018

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00001491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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