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

NCT04489680 | Completed

• 1 other identifier: Cleft Palate 3D Simulator
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate Lip

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Surgical Trainees undergoing Cleft Palate Training

EXPERIMENTAL

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

Interventions

Educational OTHER

Teaching session

Surgical Trainees undergoing Cleft Palate Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Plastic Surgery Training Residents

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas Hospital Plastic Surgery

London, United Kingdom

Location

Study Officials

• Kezia Echlin

  Birmingham Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 28, 2020
• Study Start: January 1, 2019
• Primary Completion: April 30, 2019
• Study Completion: August 31, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anonymous data will be available on request to the authors. Data will be kept for 15 years minimum.
• Access Criteria: The request needs to be done by a practicing clinician, able to provide registration proof.

Locations

GB (1)