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

The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate Patients About Surgery: A Survey

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.

Study Overview

• Status: Completed
• Conditions: Pathological Conditions, Anatomical; Deviated Nasal Septum

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Indiana
    • South Bend, Indiana, United States, 46635
      • Michiana ENT Specialty Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 adult patients considering sinus surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Control, no anatomical model used for description
2; Anatomical model used for description

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Notre Dame
• Investigators: Principal Investigator: Douglas R Liepert, M.D., Notre Dame

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical
• Other Study ID Numbers: 14-07-1962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be freely shared upon email request.