Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient anxiety | 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. | Within 30 minutes before and 30 minutes after the preoperative counselling session. |
| Change in patient knowledge using a self-developed questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40459895 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Masking was not performed as it was not feasible
Not provided
|
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. |
| Within 30 minutes before and 30 minutes after the preoperative counselling session. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001523 | Mental Disorders |