Preoperative 3D Models and Shared Decision-making

Vanderbilt University Medical Center

Status: Completed

Conditions: Informed Consent; Shared Decision Making; Anxiety; Colorectal Cancer

Treatments: Other: 3D-printed model

Study type: Interventional

Funder types: Other

Identifiers

NCT06625008

211314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be >18 years
• Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum

Exclusion criteria

• Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

3D-printed model arm

Experimental group

Description:

Surgeons in this arm will use a 3D-printed modular human torso model with a magnetically detachable colon and rectum to teach patients about the anatomy and proximity of colonic segments undergoing surgery, potential surgical complications, and operative procedures during the pre-operative consent.

Treatment:

Other: 3D-printed model

Standard care arm

No Intervention group

Description:

Surgeons will employ the usual pre-operative counseling in this arm. This will include teaching patients about the anatomy, operative procedures, and potential surgical complications during the pre-operative consent using 2D images.