Peritoneum Vaginoplasty; Implementation According to IDEAL Framework

NCT05925361 | Unknown

• 1 other identifier: NL80365
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

• 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

Study Arms (1)

intervention

EXPERIMENTAL

All participants will undergo a laparoscopic single flap peritoneum vaginoplasty

Procedure: Laparoscopic pedicled single flap peritoneum vaginoplasty

Interventions

Laparoscopic pedicled single flap peritoneum vaginoplasty PROCEDURE

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: one of two groups consists of transgender or gender diverse individuals, who desire feminizing genital surgery. So they are assigned male at birth, but identify as female or gender diverse.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for vaginoplasty, with no option to use penoscrotal tissue or with shortage of penoscrotal tissue.
• Age \>18
• Able to give informed consent

You may not qualify if:

• Contra-indication for laparoscopic surgery
• Smoking (cessation for at least 6 weeks)
• BMI 18 \< or \>30 kg/m2

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, South Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (6)

• 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.

  PMID: 28839860 BACKGROUND

• 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.

  PMID: 26632208 BACKGROUND

• 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.

  PMID: 27087418 BACKGROUND

• 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.

  PMID: 30707129 BACKGROUND

• 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.

  PMID: 34398096 BACKGROUND

• 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.

  PMID: 33776039 BACKGROUND

MeSH Terms

Conditions

Mullerian aplasia; Vaginal Neoplasms; Gender Dysphoria

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Mark-Bram Bouman, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marleen Vallinga, MD

CONTACT

+31204440162; m.s.vallinga@amsterdamumc.nl

Alessanda Sarsini

CONTACT

+31204440162; a.sarsini@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Clinical Professor in plastic surgery and Head of department of Plastic Surgery

Model Details: Single center prospective intervention study

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: June 29, 2023
• Study Start: May 25, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)