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A randomized clinical trial to study results of vaginoplasty with and without the use of additional full thickness skin graft in male to female transsexuals

A randomized clinical trial to study results of vaginoplasty with and without the use of additional full thickness skin graft in male to female transsexuals - Vaginoplasty * a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37824
Enrollment
50
Registered
2012-06-01
Start date
2012-08-13
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

gender dysphorie gender dysphory / gender identity disorder

Interventions

Patients whom meet the above mentioned criteria will be operated by a plastic surgeon of the gender team. Vaginoplasty will be performed in all patients. Patients eligible for the randomized trial w

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: male to female transsexual older than 18 years willing to undergo the sex reassignment surgery by means of a vaginoplasty willing to participate BMI

Exclusion criteria

Exclusion criteria: BMI > 30 IQ under 90 Smoking circumcision For randomized group: penis length shorter than 12 cm

Design outcomes

Primary

MeasureTime frame
The primary end point of the study is vaginal depth and width. Measurements will be taken will be taken per-operatively, at six months and at one year after surgery. Depth and width of the vagina at six months and one year will be compared to measurements taken during the operation. Postoperatieve values will be compared to per-operative values in order to assess the amount of shrinkage.

Secondary

MeasureTime frame
Secondary outcomes are the aesthetic result, patient satisfaction, complications and reoperations. Aesthetic results will be assessed by patients, surgeons, and independent observers. These measurements will be performed at 6 months and one year after the last surgery. All complications and reoperations will be registered.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)