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

NCT02905344 | Completed

• 1 other identifier: 14-07-1962
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pathological Conditions, Anatomical; Deviated Nasal Septum

Outcome Measures

Primary Outcomes (1)

• Question: How did the doctor's visualization help you in your understanding of the surgery?

  1 year

Study Arms (2)

1

Control, no anatomical model used for description

2

Anatomical model used for description

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 adult patients considering sinus surgery

You may qualify if:

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

You may not qualify if:

• Patients who or not able to read or understand English

Sponsors & Collaborators

• University of Notre Dame: lead

Study Sites (1)

Michiana ENT Specialty Center

South Bend, Indiana, 46635, United States

Location

MeSH Terms

Conditions

Pathological Conditions, Anatomical

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas R Liepert, M.D.

  Notre Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 19, 2016
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 19, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)