Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Use of 3D-printed patient-specific models for patient education
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Use 3D printed patient specific models for patient education (Other)
结局指标
主要结局
Use of 3D-printed patient-specific models for patient education
时间窗: Baseline
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.
Participant-reported understanding of gender-affirming vaginoplasty following use of 3D models.
时间窗: immediately after baseline visit
To evaluate participant knowledge and satisfaction with use of 3D Models for discussing Gender- affirming vaginoplasty surgery.
次要结局
未报告次要终点