NCT05925361: PeriVaS

Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

Status unknown NA Last updated 29 June 2023

What this trial tests

NA trial testing Laparoscopic pedicled single flap peritoneum vaginoplasty in Rokitansky Kuster Hauser Syndrome in 13 participants. Status unknown.

Timeline

25 May 2023

Primary endpoint
1 December 2024

1 March 2025

Quick facts

Lead sponsor	Amsterdam UMC, location VUmc
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	25 May 2023
Primary completion	1 December 2024
Estimated completion	1 March 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• Laparoscopic pedicled single flap peritoneum vaginoplasty

Conditions studied

• Rokitansky Kuster Hauser Syndrome — all drugs for Rokitansky Kuster Hauser Syndrome →
• Vaginal Neoplasms — all drugs for Vaginal Neoplasms →
• Gender Incongruence — all drugs for Gender Incongruence →
• Vaginal Obstruction — all drugs for Vaginal Obstruction →

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

18 and older, any sex, with Rokitansky Kuster Hauser Syndrome or Vaginal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to assess if a single flap peritoneum vaginoplasty is safe and feasible.The IDEAL framework for evaluation and implementation of surgical techniques will be used. There are two patient groups who are eligible to undergo this procedure. The first group consists of transgender women who either have a shortage of penile skin (so they cannot undergo standard operation technique: penile inversion) or a stenosis of their primary neovagina. The second group consists of women who are born without a vagina or have an acquired short or absent vagina after vaginectomy or hysterectomy because of malignancy of the cervix or vagina. At the moment, standard procedure for both groups in the Amsterdam University Medical Center (UMC) is the sigmoid vaginoplasty, where a part of the bowel is used to form a vaginal cavity. This procedure is risky, because in some cases, the bowel anastomosis is defect. An other more frequent complication, is malodorous excessive discharge. Sometimes accompanied by inflammation of the diversion neovagina.

In recent years, the use of the peritoneum vaginoplasty has been described for transgender women. However, the peritoneum is either used as small flaps to deepen the vagina, or the peritoneum is pulled down, which limits the depth of the neovagina. We want to implement a different technique, where the peritoneum is harvested in a single pedicled flap, which is brought down and sutured in the cavity cylinder shaped. The risks are the same as in any laparoscopic surgery, but we suspect the risk of failure of the anastomosis is much lower, as is the chance of a temporary stoma.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.