NCT06625008

Preoperative 3D Models and Shared Decision-making

Impact of 3D-Printed Model on Shared Decision-Making and Anxiety in Patients Undergoing Surgery: the SEAD Pilot Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.

Detailed description

In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.

Conditions

• Colorectal Cancer
• Shared Decision Making
• Anxiety
• Informed Consent

Interventions

Type	Name	Description
OTHER	3D-printed model	The Department of Radiology at Vanderbilt University Medical Center will create a 3D-printed human torso model that includes the colon, rectum, and a stoma on the abdominal wall. This model will be used to provide pre-operative counseling during the surgical consent for patients.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-06-01
• Completion: 2024-08-15
• First posted: 2024-10-03
• Last updated: 2024-10-03

Locations

1 site across 1 country: United States