Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

Trial Title: Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

NCT ID: NCT05925361

Condition: Rokitansky Kuster Hauser Syndrome
Vaginal Neoplasms
Gender Incongruence
Vaginal Obstruction
Penoscrotal Hypoplasia

Conditions: Official terms:
Vaginal Neoplasms
Gender Dysphoria

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single center prospective intervention study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Laparoscopic pedicled single flap peritoneum vaginoplasty
Description: After the perineal part of the operation, in which the vaginal cavity will be dissected, a laparoscopy will be started. During laparoscopy, a single flap peritoneum will be harvested. The flap will be checked for adequate blood supply. The flap will be brought down to the (neo) vaginal cavity and sutured around a dilatator cylinder wise.
Arm group label: intervention

Summary: 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.

Detailed description: 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 entails 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. However, in these publications the peritoneum is either used as small flaps to deepen the vagina, or the peritoneum is pulled down. The investigators 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 in transgender women with penoscrotal hypoplasia or obliteration of the primary neovagina and in cis-women with congenital or acquired lack of vaginal depth.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Indication for vaginoplasty, with no option to use penoscrotal tissue or with shortage of penoscrotal tissue. - Age >18 - Able to give informed consent Exclusion Criteria: - Contra-indication for laparoscopic surgery - Smoking (cessation for at least 6 weeks) - BMI 18 < or >30 kg/m2

Gender: All

Gender based: Yes

Gender description: one of two groups consists of transgender or gender diverse individuals, who desire feminizing genital surgery. So they are assigned male at birth, but identify as female or gender diverse.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Amsterdam University Medical Center

Address:
City: Amsterdam
Zip: 1081 HV
Country: Netherlands

Status: Recruiting

Contact:
Last name: Marleen S Vallinga, MD

Phone: +31204444444
Email: m.s.vallinga@amsterdamumc.nl

Contact backup:
Last name: Mark-Bram Bouman, MD PhD

Phone: +31 204444444
Email: mark-bram.bouman@amsterdamumc.nl

Investigator:
Last name: Marleen S Vallinga, MD
Email: Sub-Investigator

Start date: May 25, 2023

Completion date: March 1, 2025

Lead sponsor:
Agency: Amsterdam UMC, location VUmc
Agency class: Other

Source: Amsterdam UMC, location VUmc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05925361