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

Gender reassignment surgery is still shrouded in secrecy. There are only few
centres where this surgery is performed in a limited number of countries. The
number of scientific publications in this area is very linited and no studies
are performed to objectively assess this type of surgery.
Vaginoplasty is part of surgical reassignment of male to female transsexuals.
The use of inversed penile skin has been wide spread in the construction of the
neo-vagina of male to female transsexuals. The rationale behind this choice is
that there is less shrinkage of the vascularised skin of the penis than of the
full thickness skin graft (FTG) taken from elsewhere. In the case of a too
small penis, the deepest part of the vaginal cavity is lined with a FTG, whilst
the rest of the cavity is lined with penile skin. In recent years there has
been a tendency to line most of the vaginal cavity with FTG*s and use the
penile skin mostly for the shaping of the vulva. Stating that the use of more
penile skin for the vulva gives a better esthetical appearance. However, there
is no consensus about the optimal technique and outcomes of vaginoplasty have
never been assessed in an objective manner.

The aim of this study is to measure if there are differences in maintaining
vaginal depth and in aesthetic results between patients who underwent
construction of a neo-vagina with penile skin only, or with penile skin
combined with FTG.

Randomized double blinded interventional study and a parallel observational
cohort study.

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 will be randomized to treatment
group 1 or 2 on the morning of the operation. In treatment group 1, only the
penile skin will be used for construction of the vagina, in treatment group 2
penile skin + FTG will be used for the construction of the vagina. In the
observational study group penile skin + FTG will be used for the construction
of the vagina. Further treatment will be as written in the already existent
protocols.

With regard to the intervention no extra burden will be placed on the patient.
There are no extra risks involved in either operation as both methods of
vaginal reconstruction are already being used regularly by the participating
surgeons. Treatment and follow-up is exactly as in the existing protocol. The
only extra burden on the patient comprises the time to fill in the
questionnaires. Admission time and the frequency of out patient visits will be
the same as in the normal treatment (prior protocol).