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

Vaginoplasty is the surgical (re)construction of a neo- vagina. At the moment,
the standard procedure to construct a neo-vagina is a penile inversion
vaginoplasty. Where the skin of the penis is used as lining of the neovagina.
When there is insufficient or no penile skin available, up to now the standard
procedure is to form a neovagina through a diversion of the large bowel. This
enatials extensive colorectal surgery with potential major morbidity. Another
complication of this procedure that is more frequent, is malodorous excessive
discharge due to colitis of the bowel conduit. Furthermore, ant theoretical
risk of malignancy of the diversion vagina is present due to the chronic
inflammations . A less morbid peritoneum *pull down* vaginoplasty is a
well-known and widely used alternative technique for cis-women who are born
without a vagina. However, the technique limits the maximum achievable depth
and subsequent functional outcome. By using a single pedicled peritoneum flap,
it is possible to create more depth.
In recent years, the peritoneum vaginoplasty is also performed in transgender
women, with reported good results [4-6]. However, in these publications the
peritoneum is either used as small flaps to deepen the vagina, or the
peritoneum is pulled down. We propose to introduce an optimized technique,
based upon a single pedicled peritoneal flap, which is brought down and sutured
in the vaginal cavity to form a cylinder. The perioperative risks are suspected
to be substantially lower with minimal chance of bowel leakage and thereby the
risk on re-interventions or a temporary stoma. Second, at long term the chance
of malodorous discharge and chronic inflammation is lower, which is expected to
result in improved satisfaction and sexual function.
This study aims to assess if the single flap pedicled peritoneum vaginoplasty
is safe and feasible. There are two groups who are eligible to undergo this
procedure: 1) trans-women who have not enough penile skin to undergo the
standard vaginoplasty procedure or who have an obliteration of the primary
neovagina; 2) cis-women who do not have a vagina due to a congenital condition
or a previous malignancy.

Primary Objective:
To assess the safety of the single flap peritoneum vaginoplasty procedure by
studying adverse events and complications during, directly after and within 90
days of the operation.

Secondary Objectives:
- To assess short- (12 weeks after operation) and long-term (between 3-12
months) physiological and clinical outcomes to assess the success of the
technique in terms of functionality.
- To assess the technical success and development of the procedure, and to work
towards a standardized optimized version.

This study is a prospective intervention study.

The study design is according to the IDEAL framework for surgical innovation
that is innovative, but for which already some evidence exists regarding safety
and feasibility. See table 1 in chapter 1 for a detailed overview of stages.
Stage 1 of IDEAL entails a proof of concept in 3 patients, the aim is to see if
the intervention is feasible and safe. Stage 2a involves a prospective case
series of 10 patients. Both stages are single center and surgeons will be the
same, as the aim is to develop the technique until it is stable. Safety is the
most important outcomes in both stages

The duration of the study will be two years, or less if the sample size is met
before. The results of this study will be compared with results from literature
of the sigmoid vaginoplasty, to determine if we will proceed to the next IDEAL
stages (pre-RCT study and RCT). The number of patients that are excluded and
the reason for exclusion will be registered.

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

The burden of the procedure is comparable to the procedure of usual care (with
the use of sigmoid diversion). Our hypothesis is that there will be shorter
recovery, because the bowel is not affected and no anastomosis will be made
with associated morbidity. There is no extra burden of the study for the
participants, apart from undergoing the intervention. The pre-operative and
post-operative care are the same, as is the follow-up schedule. There are no
extra physical examinations or other tests. No extra visits are needed. If the
operation is not successful; does not provide a functional vagina, there is
always the option to perform an bowel diversion vaginoplasty afterwards. For an
extensive description of risks associated with vaginoplasty, see document B2.5
NFU risicoclassificatie.
The risks of the intervention are related to the approach and the anaesthesia.
The chance of damage to nearby structures (rectum, urethra) because of the open
approach phase where the cavity is created, is the same as in standard care
(bowel vaginoplasty). The risk of damaging structures during laparoscopy is
identical as during other laparoscopies. There is risk of damaging bowel,
bladder, bleeding or infection. Furthermore there is risk of damaging
structures during the start of laparoscopy, infections of the incisions for the
trocars. In addition to operation risk, there is the risk of anesthesia related
complications. Because no bowel anastomosis is created, the risk of bowel
leakage or necrosis of the diverted bowel is non-excistent.