Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
Primary Purpose
Cleft Palate Lip
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Educational
Sponsored by
About this trial
This is an interventional other trial for Cleft Palate Lip
Eligibility Criteria
Inclusion Criteria:
- Plastic Surgery Training Residents
Exclusion Criteria:
-
Sites / Locations
- Guys and St Thomas Hospital Plastic Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgical Trainees undergoing Cleft Palate Training
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04489680
First Posted
June 25, 2020
Last Updated
July 25, 2020
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04489680
Brief Title
Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
Official Title
Educational Impact and Development of a Novel Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate Lip
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical Trainees undergoing Cleft Palate Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational
Intervention Description
Teaching session
Primary Outcome Measure Information:
Title
Cleft lip palate surgical knowledge
Description
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
Time Frame
Day 1
Title
Cleft lip palate surgical confidence
Description
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
Time Frame
Day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Plastic Surgery Training Residents
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kezia Echlin
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guys and St Thomas Hospital Plastic Surgery
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
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