Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925361
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2022-02-07
Brief Title:
Peritoneum Vaginoplasty Implementation According to IDEAL Framework
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Pedicled Peritoneum Vaginoplasty in Feminizing Genital Surgery Implementation According to IDEAL Framework
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeriVaS
Brief Summary:
This study aims to assess if a single flap peritoneum vaginoplasty is safe and feasibleThe 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
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 reconstruction 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None