Preoperative 3D Models and Shared Decision-making

Not Applicable

Completed

• Conditions: Colorectal Cancer; Shared Decision Making; Anxiety; Informed Consent
• Interventions: Other: 3D-printed model

• Registration Number: NCT06625008
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2024-08-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D-printed model arm	3D-printed model	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.

Primary Outcome Measures

Name	Time	Method
Shared decision making	Within 30 minutes after the preoperative counselling session.	Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.

Secondary Outcome Measures

Name	Time	Method
Change in patient anxiety	Within 30 minutes before and 30 minutes after the preoperative counselling session.	Quantify and compare patient anxiety levels before and after the pre-operative consent, measured by the validated State-Trait Anxiety Inventory (STAI-6) among the study arms.
Change in patient knowledge using a self-developed questionnaire	Within 30 minutes before and 30 minutes after the preoperative counselling session.	Using a self-developed questionnaire to quantify and compare patient knowledge of the essential aspects of anatomy, disease, and surgical procedure covered in preoperative counseling to understand how patient knowledge improves with counseling and compares between the study arms.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States