Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty? (3D Modeling)

The project aims to address both clinical and relational gaps in transgender surgical care by improving understanding, communication, and outcomes through this novel integration of personalized 3D technology.

The hypothesis is that using 3D models of patient specific anatomy will enhance patient understanding and education into how peritoneal vaginoplasty is done, while also improving surgical planning and therefore outcomes by decreasing OR time and reducing complication rates. The investigators seek to foster stronger physician-patient relationships by improving communication and shared decision-making, ultimately helping transgender patients feel more empowered, engaged, and willing to seek care in the future.

Study Overview

• Status: Not yet recruiting
• Conditions: Gender Dysphoria, Adult; Vaginoplasty
• Intervention / Treatment: Other: Use 3D printed patient specific models for patient education

Detailed Description

To accomplish our objectives there will be two phases to our study: a retrospective feasibility phase, and a prospective survey study with concurrent use of 3D printed patient models for surgical planning. In the retrospective feasibility phase, a chart review from 3/1/2024 - 3/31/2025 of those who have already undergone peritoneal vaginoplasty will be completed to identify those who have had a previous CT Abdomen/ Pelvis scan. Data that will be collected from this cohort includes patient sex assigned at birth, gender, age, past surgical history, and imaging. The identification of imaging is not standard of care, and being done for research purposes only. The images from those scans will be used to print 3D models of patient anatomy. Using the CT scans exported as DICOM files, images will be viewed and rendered into 3D space using software Bambu Studio. The files from Bambu will then be exported as an STL file which will allow Autodesk Fusion software to clean the images prior to printing. No patient identifiers will be used when using the 3D modeling software. No patient identifiers will be used when using the 3D modeling software. Multiple models will be printed to determine optimal visualization and use for future surgical planning.

In the prospective survey study, the investigators will distribute one electronic survey via RedCap to patients who have been identified through the Trans CARE Clinic with the below stated inclusion criteria. The patients will be introduced to the study via recruitment email. If the patient agrees to participate in the study and completes the consent form via e-consent, a 3D model will be used to educate the patient on the steps of peritoneal vaginoplasty procedure, complications, and anatomy at their next clinic visit appointment. At their clinic visit, they will be reminded that this 3D model is part of the study they have consented to. Once their appointment has been completed, they will then be redirected to the RedCap Survey .

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Courtney Cripps; Phone Number: 773-834-3631; Email: ccripps@bsd.uchicago.edu
• Study Contact Backup: Name: Taylor Chiang; Email: taylor.chiang@uchicagomedicine.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
      • Contact: Taylor Chiang; Email: taylor.chiang@uchicagomedicine.org
      • Contact: Courtney Cripps, MD; Phone Number: 773-834-3631; Email: ccripps@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected based on their attendance to Trans CARE clinic at the University of Chicago, a diagnosis of gender dysphoria, and desire to undergo gender affirming vaginoplasty

Description

Inclusion Criteria:

Assigned Male at birth (AMAB) subjects ≥ 18 years old who have been evaluated through the Trans CARE Clinic for gender affirmation at the University of Chicago

• Have a diagnosis of gender dysphoria
• Seeking Vaginoplasty
• Able to provide electronic informed consent in English

Exclusion Criteria:

• Vulnerable subjects (children, prisoners, pregnant women) will be excluded Participants may withdraw from this study for any reason at any point by actively asking a research team member. All investigations and standard clinical care will be performed at the main campus of The University of Chicago Medicine at 5841 S. Maryland Ave. in Chicago, IL.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria; Assigned Male at birth (AMAB), greater than equal to18 years old who have been evaluated through the Trans CARE Clinic for gender affirmation at the University of Chicago	Other: Use 3D printed patient specific models for patient education; To use 3D printing to generate patient-specific models of abdominal and pelvic anatomy to educate patients about the procedure, including risks, benefits, and potential complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of 3D-printed patient-specific models for patient education	To use 3D printing to generate patient-specific models of abdominal and pelvic anatomy to educate patients about the procedure, including risks, benefits, and potential complications.	Baseline
Participant-reported understanding of gender-affirming vaginoplasty following use of 3D models.	To evaluate participant knowledge and satisfaction with use of 3D Models for discussing Gender- affirming vaginoplasty surgery.	immediately after baseline visit

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Patient Education as Topic
• Other Study ID Numbers: IRB25-1252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No