Peritoneum Vaginoplasty; Implementation According to IDEAL Framework (PeriVaS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Neoplasms; Gender Incongruence; Rokitansky Kuster Hauser Syndrome; Vaginal Obstruction; Penoscrotal Hypoplasia
• Intervention / Treatment: Procedure: Laparoscopic pedicled single flap peritoneum vaginoplasty

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.

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marleen Vallinga, MD; Phone Number: +31204440162; Email: m.s.vallinga@amsterdamumc.nl
• Study Contact Backup: Name: Alessanda Sarsini; Phone Number: +31 +31204440162; Email: a.sarsini@amsterdamumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Amsterdam, Zuid-Holland, Netherlands, 1081 HV
      • Recruiting
      • Amsterdam University Medical Center
      • Contact: Marleen S Vallinga, MD; Phone Number: +31204444444; Email: m.s.vallinga@amsterdamumc.nl
      • Contact: Mark-Bram Bouman, MD PhD; Phone Number: +31 204444444; Email: mark-bram.bouman@amsterdamumc.nl
      • Sub-Investigator: Marleen S Vallinga, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intervention; All participants will undergo a laparoscopic single flap peritoneum vaginoplasty

Procedure: Laparoscopic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful technical completion of operation	Postoperative dimension of the neovagina of at least 12 cm, measured by a measuring dilatator.	From start of surgery until 90 days after
Operation time	Learning curve of surgeons	Intraoperative (From start of surgery up until closure of all wounds)
Blood loss	Total estimated blood loss during operation by surgeon in ml	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.	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	at 12 months post-operation
Urinary function	Urinary function measured by the urinary function form of the genderQ	at 12 months post-operation
Post-operative pain	Postoperative pain reported by patient either none-normal-or excessive	at 3 weeks, 3 months and 6 months post-operative
Neovaginal dimensions	Postoperative dimension of the neovagina, measured by a measuring dilatator.	at 3 weeks, 3 months and 6 months post-operative
Clitoral sensation	patient assessed outcome, either none- less- normal or hyper	at 3 weeks, 3 months and 6 months post-operative

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Mark-Bram Bouman, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Sexual Dysfunctions, Psychological; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Gender Dysphoria; Vaginal Neoplasms
• Other Study ID Numbers: NL80365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No