Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use 3D printed patient specific models for patient education.
- Who it may be relevant to
- Registry conditions: Vaginoplasty, Gender Dysphoria, Adult. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Use of 3D-printed patient-specific models for patient education [Time frame: Baseline]
- Participant-reported understanding of gender-affirming vaginoplasty following use of 3D models. [Time frame: immediately after baseline visit]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Chicago — Chicago
Identifiers
NCT: NCT07412509 · IRB25-1252