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Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

NCT05925361UNKNOWNNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Amsterdam UMC, location VUmc

Enrollment

Start Date

2023-05-25

Completion Date

2024-12-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Laparoscopic pedicled single flap peritoneum vaginoplasty

Conditions

Rokitansky Kuster Hauser SyndromeVaginal NeoplasmsGender IncongruenceVaginal ObstructionPenoscrotal Hypoplasia

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

90 day postoperative complications. Reported by full description of the event and eventual treatment and classified according to Clavien-Dindo classification.

Reported by full description of the event and eventual treatment and classified according to Clavien-Dindo classification.

Time frame: From start of surgery until 90 days after surgery

Secondary Outcomes

Successful technical completion of operation

Postoperative dimension of the neovagina of at least 12 cm, measured by a measuring dilatator.

Time frame: From start of surgery until 90 days after

Operation time

Learning curve of surgeons

Time frame: Intraoperative (From start of surgery up until closure of all wounds)

Blood loss

Total estimated blood loss during operation by surgeon in ml

Time frame: Intraoperative (From start of surgery up until closure of all wounds)

Length of hospital stay

The total amount of days spend in the hospital after operation up until discharge.

Time frame: From date of operation/intervention until the date of discharge or death, whichever came first, assessed up to 100 days

Sexual function

Sexual function measured by the sexual function form of the genderQ

Time frame: at 12 months post-operation

Urinary function

Urinary function measured by the urinary function form of the genderQ

Time frame: at 12 months post-operation

Post-operative pain

Postoperative pain reported by patient either none-normal-or excessive

Time frame: at 3 weeks, 3 months and 6 months post-operative

Neovaginal dimensions

Postoperative dimension of the neovagina, measured by a measuring dilatator.

Time frame: at 3 weeks, 3 months and 6 months post-operative

Clitoral sensation

patient assessed outcome, either none- less- normal or hyper

Time frame: at 3 weeks, 3 months and 6 months post-operative

Locations

Amsterdam University Medical Center, Amsterdam, Netherlands

Linked Diseases

Vaginal Neoplasms

Vaginal Neoplasms — a type of gynecological cancer.