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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis of gender dysphoria

Seeking Vaginoplasty

Able to provide electronic informed consent in English

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Use 3D printed patient specific models for patient education

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
immediately after baseline visit

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: