Validating an Inexpensive Practice Model for Microsurgical Skills Training

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Completed
CT.gov ID
NCT04093063
Collaborator
(none)
27
1
2
12.7
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Micro-stellated Icosahedron
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
An Inexpensive Practice Model for Microsurgical Skills Training: A Randomized Trial
Actual Study Start Date :
Jun 30, 2017
Actual Primary Completion Date :
Jul 23, 2018
Actual Study Completion Date :
Jul 23, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

  3. Change in time required to pass a needle. [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.

  4. Change in time required to complete microsurgical tie. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 year-old or older.

  • No prior microsurgical experience.

Exclusion Criteria:
  • Prior microsurgical experience.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jacobs School of Medicine and Biomedical Sciences Buffalo New York United States 14203

Sponsors and Collaborators

  • State University of New York at Buffalo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sangita Patel, Principal Investigator, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT04093063
Other Study ID Numbers:
  • STUDY00001491
First Posted:
Sep 17, 2019
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sangita Patel, Principal Investigator, State University of New York at Buffalo

Study Results

No Results Posted as of Oct 22, 2020