Pedicled Peritoneum Vaginoplasty in feminizing genital Surgery; implementation according to IDEAL framework

Pedicled Peritoneum Vaginoplasty in feminizing genital Surgery; implementation according to IDEAL framework - PeriVaS

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51660

Enrollment

Registered

2022-11-02

Start date

2023-05-25

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

genderdysforie genderdysforia with wish for gender affirming surgery and acquired or congenital diminshed vaginal depth

Interventions

All subject in this study will undergo a laparoscopic pedicled single flap peritoneum vaginoplasty.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Indication for vaginoplasty: o transgender women: indication for vaginoplasty according to the standards of care and not eligible to undergo penile inversion vaginoplasty due to a shortage of penile/scrotal skin. o Cis women: women with congenital vaginal agenesis or acquired diminished vaginal depth - Age of 18 years or higher - Able to give informed consent

Exclusion criteria

Exclusion criteria: - Contra-indication for laparoscopic surgery - Smoking (cessation for at least 6 weeks) - BMI 18 30 kg/m2 - Status after radiotherapy of the small pelvis

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the complications up until 90 days postoperative. Complications are reported by full description of the event and eventual treatment. They are classified according to the Clavien-Dindo classification.	—

Secondary

Measure	Time frame
Technical outcomes: Changes made to any of the steps in the procedure, reasons for change of procedure, successful technical completion, operative time and subjective experience of surgeons. Intra- and direct post-operative outcomes: Dimensions (depth and width) of neovagina, measured with measuring dilatators, blood loss, adverse events, conversion of procedure for successful result of procedure (e.g., to open), length of hospital stay. Clinical outcomes: During follow-up at 3/6/12 months: Dimensions (depth and width) of neovagina micturition: infections, characteristics of voiding jet Pain: score, characteristics, location and treatment Sexual function: sensitivity of clitoris (normal, hyper- or hyposensitive), ability to engage in penetrative sex, ability to orgasm. Satisfaction with aesthetics of vulva and vagina.	—

Measure

Time frame

Technical outcomes: Changes made to any of the steps in the procedure, reasons for change of procedure, successful technical completion, operative time and subjective experience of surgeons. Intra- and direct post-operative outcomes: Dimensions (depth and width) of neovagina, measured with measuring dilatators, blood loss, adverse events, conversion of procedure for successful result of procedure (e.g., to open), length of hospital stay. Clinical outcomes: During follow-up at 3/6/12 months: Dimensions (depth and width) of neovagina micturition: infections, characteristics of voiding jet Pain: score, characteristics, location and treatment Sexual function: sensitivity of clitoris (normal, hyper- or hyposensitive), ability to engage in penetrative sex, ability to orgasm. Satisfaction with aesthetics of vulva and vagina.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)