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
Completed
- Conditions
- gender dysphoriegender dysphory / gender identity disorder
- Registration Number
- NL-OMON37824
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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 < 30
able to fill in informed consent
able to fill in questionnaires
Exclusion Criteria
BMI > 30
IQ under 90
Smoking
circumcision
For randomized group: penis length shorter than 12 cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary end point of the study is vaginal depth and width. Measurements<br /><br>will be taken will be taken per-operatively, at six months and at one year<br /><br>after surgery. Depth and width of the vagina at six months and one year will be<br /><br>compared to measurements taken during the operation. Postoperatieve values will<br /><br>be compared to per-operative values in order to assess the amount of shrinkage.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are the aesthetic result, patient satisfaction,<br /><br>complications and reoperations. Aesthetic results will be assessed by patients,<br /><br>surgeons, and independent observers. These measurements will be performed at 6<br /><br>months and one year after the last surgery. All complications and reoperations<br /><br>will be registered.</p><br>