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NCT04489680

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

Completed NA Last updated 28 July 2020
What this trial tests

NA trial testing Educational in Cleft Palate Lip in 26 participants. Completed in 31 August 2019.

Timeline
1 January 2019
Primary endpoint
30 April 2019
31 August 2019

Quick facts

Lead sponsorGuy's and St Thomas' NHS Foundation Trust
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment26
Start date1 January 2019
Primary completion30 April 2019
Estimated completion31 August 2019
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

Eligibility, any sex, with Cleft Palate Lip. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Educational

Trials testing the same drug.

Other Guy's and St Thomas' NHS Foundation Trust trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04489680.

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