Preoperative 3D Models and Shared Decision-making

NCT06625008 | Completed

• 1 other identifier: 211314
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Shared Decision Making; Anxiety; Informed Consent

Keywords

Colorectal cancer; 3D Model; Shared Decision Making; Preoperative anxiety; Patient knowledge; Informed Consent

Outcome Measures

Primary Outcomes (1)

• Shared decision making

  Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.

  Within 30 minutes after the preoperative counselling session.

Secondary Outcomes (2)

• Change in patient anxiety

  Within 30 minutes before and 30 minutes after the preoperative counselling session.

• Change in patient knowledge using a self-developed questionnaire

  Within 30 minutes before and 30 minutes after the preoperative counselling session.

Study Arms (2)

3D-printed model arm

EXPERIMENTAL

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.

Other: 3D-printed model

Standard care arm

NO INTERVENTION

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.

Interventions

3D-printed model OTHER

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.

3D-printed model arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Khan A, Sellyn GE, Ali D, Moazzam Z, Samaras H, McChesney SL, Hopkins MB, Ford MM, Muldoon RL, Geiger TM, Martin D, Chu DI, VanKoevering KK, Hawkins AT. Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513187. doi: 10.1001/jamanetworkopen.2025.13187.

  PMID: 40459895 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not performed as it was not feasible
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 3, 2024
• Study Start: March 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 15, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)