Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.

Educational Impact and Development of a Novel Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.

Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair.

Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

Study Overview

• Status: Completed
• Conditions: Cleft Palate Lip
• Intervention / Treatment: Other: Educational

Detailed Description

Background: Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair.

Methods: Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Guys and St Thomas Hospital Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Plastic Surgery Training Residents

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Surgical Trainees undergoing Cleft Palate Training; 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.	Other: Educational; Teaching session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleft lip palate surgical knowledge	The knowledge questionnaire was a 10-part questionnaire, developed through consensus between a panel of expert cleft surgeons. Answers were marked by a single assessor according to the agreed marking criteria and participants received a score of 0-10	Day 1
Cleft lip palate surgical confidence	The confidence questionnaire was a 10-part questionnaire, each scored on a Likert scale of 1-5 that has previously been published and validated for use in cleft palate surgery(Appendix 3).(18) The total score ranged from 10-50, converted by division of 10 to an overall confidence score of 1-5 with 1 being not at all confident to 5 being very confident/at the level of an attending/consultant surgeon	Day 1

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Kezia Echlin, Birmingham Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (ACTUAL): July 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: Cleft Palate 3D Simulator

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request
• IPD Sharing Time Frame: Anonymous data will be available on request to the authors. Data will be kept for 15 years minimum.
• IPD Sharing Access Criteria: The request needs to be done by a practicing clinician, able to provide registration proof.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No