Effectiveness of Using 3D Printed Models to Educate Otolaryngology (Ear, Nose, Nose and Throat (ENT)) Patients About Surgery: A Survey

Completed

• Conditions: Deviated Nasal Septum; Pathological Conditions, Anatomical

• Registration Number: NCT02905344
• Lead Sponsor: University of Notre Dame

Brief Summary

Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients follow through with elective surgeries to fix ailments like a deviated septum or occluded sinus passage. Patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. Here the investigators report the usage of advanced inkjet 3D printing methods to develop a multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray Computed Tomography (CT) data. The final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. A two arm, single center, randomized, prospective study was then performed in which 50 ENT surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. Each patient was then surveyed for their self-rated understanding of their anatomy, disease, and treatment options.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-13
• Last Update Submitted: 2016-09-13
• Study First Posted: 2016-09-19
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male and female subjects that are 18 years or older.
• Surgeon must have recommended nasal or sinus surgery
• Not excluded as a surgical candidate

Exclusion Criteria

• Patients who or not able to read or understand English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Question: How did the doctor's visualization help you in your understanding of the surgery?	1 year

Trial Locations

Locations (1)

Michiana ENT Specialty Center; 🇺🇸 South Bend, Indiana, United States