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Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

Pedicled Peritoneum Vaginoplasty in Feminizing Genital Surgery; Implementation According to IDEAL Framework

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05925361
Acronym
PeriVaS
Enrollment
13
Registered
2023-06-29
Start date
2023-05-25
Completion date
2025-03-01
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Incongruence, Penoscrotal Hypoplasia, Rokitansky Kuster Hauser Syndrome, Vaginal Neoplasms, Vaginal Obstruction

Brief 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.

Interventions

PROCEDURELaparoscopic pedicled single flap peritoneum vaginoplasty

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.

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single center prospective intervention study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
90 day postoperative complications. Reported by full description of the event and eventual treatment and classified according to Clavien-Dindo classification.From start of surgery until 90 days after surgeryReported by full description of the event and eventual treatment and classified according to Clavien-Dindo classification.

Secondary

MeasureTime frameDescription
Operation timeIntraoperative (From start of surgery up until closure of all wounds)Learning curve of surgeons
Blood lossIntraoperative (From start of surgery up until closure of all wounds)Total estimated blood loss during operation by surgeon in ml
Length of hospital stayFrom date of operation/intervention until the date of discharge or death, whichever came first, assessed up to 100 daysThe total amount of days spend in the hospital after operation up until discharge.
Sexual functionat 12 months post-operationSexual function measured by the sexual function form of the genderQ
Successful technical completion of operationFrom start of surgery until 90 days afterPostoperative dimension of the neovagina of at least 12 cm, measured by a measuring dilatator.
Post-operative painat 3 weeks, 3 months and 6 months post-operativePostoperative pain reported by patient either none-normal-or excessive
Neovaginal dimensionsat 3 weeks, 3 months and 6 months post-operativePostoperative dimension of the neovagina, measured by a measuring dilatator.
Clitoral sensationat 3 weeks, 3 months and 6 months post-operativepatient assessed outcome, either none- less- normal or hyper
Urinary functionat 12 months post-operationUrinary function measured by the urinary function form of the genderQ

Countries

Netherlands

Contacts

Primary ContactMarleen Vallinga, MD
m.s.vallinga@amsterdamumc.nl+31204440162
Backup ContactAlessanda Sarsini
a.sarsini@amsterdamumc.nl+31204440162

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026