Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
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: Tubularized augmented peritoneal cap vaginoplasty, Biopsy.
- Who it may be relevant to
- Registry conditions: Gender Dysphoria, Adult. Basic parameters: 19 years — 99 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
Bottom gender affirming surgery is one of the key steps towards aligning the physical appearance and gender identity in transgender women. This surgery not only helps in reducing gender dysphoria but also significantly improves the quality of life and psychological well-being of the patients. The basic steps of bottom surgery typically involve the creation of a vagina using the skin from genital organs like the testes and penis, construction of the clitoris and labia. This complex surgery aims to create a functional and aesthetically pleasing vaginal canal that allows for sexual activity, urinary function, and a natural appearance. As part of routine care, a special graft (skin-like material) called Kerecis™ is used to line the middle part of the vagina. It is made from North Atlantic cod skin that is treated in the laboratory and made suitable for surgery purposes. It can be used instead of skin. This graft has been given permission by the Food and Drug Administration (FDA) for marketing the US. This study aims to identify changes in healing parameters following Kerecis™ based vaginoplasty. Up to 20 participants for this study. Participants will be asked to fill out study questionnaires during follow-up visits at post-op week 2, week 12, month , and year 1. At the 6 month post-op follow up, punch biopsies will be obtained from the deepest part, middle part, and the vaginal part most near to the vaginal opening parts to check the healing process using a microscope. The punch biopsies will be 1/8th inch x 1/8th inch each.
Interventions
- Procedure Tubularized augmented peritoneal cap vaginoplasty
In this surgery, the distal portion of the neovagina is constructed using inverted penile skin, the proximal portion is made of peritoneal tissue. The area in between peritoneal tissue and penile skin is lined with the Kerecis graft in this standard of care surgery. - Procedure Biopsy
Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.
Primary outcome measures
- Degree of Neovaginal Epithelialization [Time frame: Six months post-op]
- Change in Vaginal Diameter [Time frame: Post-op week 2, week, 12, month 6, and year 1]
- Change in Vaginal Depth [Time frame: Post-op week 2, week, 12, month 6, and year 1]
- Change in quality of life as measured by the Short-Form 36 (SF-36) [Time frame: Week 2, Week 12, Month 6, and year 1 post-op]
- Change in Pain as measured by the Brief Pain Inventory - Short Form (BPI-SF) [Time frame: Week 2, Week 12, Month 6, and year 1 post-op]
- Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI) [Time frame: Week 2, Week 12, Month 6, and year 1 post-op]
- Change in overall perception of improvement as measured by the PGI-I (Patient Global Impression of Improvement) [Time frame: Week 2, Week 12, Month 6, and year 1 post-op]
- Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI) [Time frame: Month 6, and year 1 post-op]
Eligibility criteria
Inclusion criteria
- Age 19-99
- Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique
Exclusion criteria
- Patients requiring Kerecis for Revision Vaginoplasty
- Surgery candidates having Zero depth vaginoplaty (ZDV)
- Non-Gender Affirming Vaginoplasty
- Cases requiring the utilization of off-the-shelf grafts other than Kerecis
- Allergy to fish products
- Allergy to local anesthetic (1% lidocaine with epinephrine injection)
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 Hospitals Cleveland Medical Center — Cleveland
Identifiers
NCT: NCT07286123 · STUDY20250076