Surgical procedure using peritoneum for vaginoplasty
Pedicled Peritoneum Vaginoplasty in Feminizing Genital Surgery; Implementation According to IDEAL Framework
NA · Amsterdam UMC, location VUmc · NCT05925361
This study is testing a new surgical method using the peritoneum for vaginoplasty to see if it can safely help transgender women and women born without a vagina who need this procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 1 site (Amsterdam, Zuid-Holland) |
| Trial ID | NCT05925361 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of a single flap peritoneum vaginoplasty for patients requiring vaginoplasty but lacking sufficient penile skin or with vaginal absence due to various conditions. The IDEAL framework will guide the implementation and assessment of this surgical technique. Two patient groups are targeted: transgender women with insufficient penile skin or stenosis of their neovagina, and women born without a vagina or who have undergone vaginectomy or hysterectomy. The study aims to provide a less morbid alternative to the current sigmoid vaginoplasty, which carries significant risks and complications.
Who should consider this trial
Good fit: Ideal candidates include transgender women with insufficient penile skin and women with congenital or acquired vaginal absence.
Not a fit: Patients who are contraindicated for laparoscopic surgery or have a BMI outside the specified range may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could offer a safer and more effective vaginoplasty option for patients with limited surgical choices.
How similar studies have performed: Previous studies have shown promising results with peritoneum vaginoplasty techniques, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for vaginoplasty, with no option to use penoscrotal tissue or with shortage of penoscrotal tissue. * Age \>18 * Able to give informed consent Exclusion Criteria: * Contra-indication for laparoscopic surgery * Smoking (cessation for at least 6 weeks) * BMI 18 \< or \>30 kg/m2
Where this trial is running
Amsterdam, Zuid-Holland
- Amsterdam University Medical Center — Amsterdam, Zuid-Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Mark-Bram Bouman, MD PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Marleen Vallinga, MD
- Email: m.s.vallinga@amsterdamumc.nl
- Phone: +31204440162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rokitansky Kuster Hauser Syndrome, Vaginal Neoplasms, Gender Incongruence, Vaginal Obstruction, Penoscrotal Hypoplasia