PeriVaS
Pedicled Peritoneum Vaginoplasty in Feminizing Genital Surgery; Implementation According to IDEAL Framework
Sponsor study identifier
interventional
13
1 country
1
Study Start
May 25, 2023
Actual (reported)Primary Completion
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2022
Actual (reported)May 25, 2023
Actual (reported)June 29, 2023
Actual (reported)December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
From start of surgery until 90 days after surgery
Successful technical completion of operation
From start of surgery until 90 days after
Operation time
Intraoperative (From start of surgery up until closure of all wounds)
All participants will undergo a laparoscopic 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Amsterdam University Medical Center
Amsterdam, South Holland, 1081 HV, Netherlands
van der Sluis WB, Bouman M, Meijerink W, Neefjes-Borst EA, van Bodegraven AA. Refractory diversion neovaginitis in a sigmoid-colon-derived neovagina: clinical and histopathological considerations. Frontline Gastroenterol. 2016 Jul;7(3):227-230. doi: 10.1136/flgastro-2015-100602. Epub 2015 Jun 4.
van der Sluis WB, Bouman MB, Meijerink WJHJ, Elfering L, Mullender MG, de Boer NKH, van Bodegraven AA. Diversion neovaginitis after sigmoid vaginoplasty: endoscopic and clinical characteristics. Fertil Steril. 2016 Mar;105(3):834-839.e1. doi: 10.1016/j.fertnstert.2015.11.013. Epub 2015 Nov 26.
Mark-Bram Bouman, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First Submitted
February 7, 2022
First Posted
June 29, 2023
Study Start
May 25, 2023
Actual (reported)Primary Completion
Blood loss
Intraoperative (From start of surgery up until closure of all wounds)
Length of hospital stay
From date of operation/intervention until the date of discharge or death, whichever came first, assessed up to 100 days
Sexual function
at 12 months post-operation
Contact the study team to confirm eligibility.
Qin C, Luo G, Du M, Liao S, Wang C, Xu K, Tang J, Li B, Zhang J, Pan H, Ball TW, Fang Y. The clinical application of laparoscope-assisted peritoneal vaginoplasty for the treatment of congenital absence of vagina. Int J Gynaecol Obstet. 2016 Jun;133(3):320-4. doi: 10.1016/j.ijgo.2015.11.015. Epub 2016 Mar 2.
Jacoby A, Maliha S, Granieri MA, Cohen O, Dy GW, Bluebond-Langner R, Zhao LC. Robotic Davydov Peritoneal Flap Vaginoplasty for Augmentation of Vaginal Depth in Feminizing Vaginoplasty. J Urol. 2019 Jun;201(6):1171-1176. doi: 10.1097/JU.0000000000000107.
Jun MS, Gonzalez E, Zhao LC, Bluebond-Langner R. Penile Inversion Vaginoplasty with Robotically Assisted Peritoneal Flaps. Plast Reconstr Surg. 2021 Aug 1;148(2):439-442. doi: 10.1097/PRS.0000000000008198. No abstract available.
Salibian AA, Schechter LS, Kuzon WM, Bouman MB, van der Sluis WB, Zhao LC, Bluebond-Langner R. Vaginal Canal Reconstruction in Penile Inversion Vaginoplasty with Flaps, Peritoneum, or Skin Grafts: Where Is the Evidence? Plast Reconstr Surg. 2021 Apr 1;147(4):634e-643e. doi: 10.1097/PRS.0000000000007779.
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 29, 2023
Record last verified: 2023-06
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