Rokitansky Kuster Hauser SyndromePeriVaSNCT05925361
Peritoneum Vaginoplasty; Implementation According to IDEAL Framework
A study testing Laparoscopic pedicled single flap peritoneum vaginoplasty in people with Rokitansky Kuster Hauser Syndrome and Vaginal Neoplasms, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rokitansky Kuster Hauser Syndrome, Vaginal Neoplasms, Gender Incongruence
- What is being tested?
- Laparoscopic pedicled single flap peritoneum vaginoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for vaginoplasty, with no option to use penoscrotal tissue or with shortage of penoscrotal tissue.
- Age >18
- Able to give informed consent
Who cannot join
- Contra-indication for laparoscopic surgery
- Smoking (cessation for at least 6 weeks)
- BMI 18 < or >30 kg/m2
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, South Holland, 1081 HV
Marleen S Vallinga, MD, +31204444444, m.s.vallinga@amsterdamumc.nl
Mark-Bram Bouman, MD PhD, +31 204444444, mark-bram.bouman@amsterdamumc.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Rokitansky Kuster Hauser Syndrome, Vaginal Neoplasms, Gender Incongruence, Vaginal Obstruction, Penoscrotal Hypoplasia
- Being tested
- Laparoscopic pedicled single flap peritoneum vaginoplasty
- Medical subject headings
- Mullerian aplasia, Vaginal Neoplasms, Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic pedicled single flap peritoneum vaginoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | All participants will undergo a laparoscopic single flap peritoneum vaginoplasty Receives: Procedure: Laparoscopic pedicled single flap peritoneum vaginoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of surgery until 90 days after surgery
Secondary outcomes (9)
Successful technical completion of operation
Postoperative dimension of the neovagina of at least 12 cm, measured by a measuring dilatator.
Measured: From start of surgery until 90 days after
Operation time
Learning curve of surgeons
Measured: Intraoperative (From start of surgery up until closure of all wounds)
Blood loss
Total estimated blood loss during operation by surgeon in ml
Measured: 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.
Measured: 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
Measured: at 12 months post-operation
Urinary function
Urinary function measured by the urinary function form of the genderQ
Measured: at 12 months post-operation
Post-operative pain
Postoperative pain reported by patient either none-normal-or excessive
Measured: at 3 weeks, 3 months and 6 months post-operative
Neovaginal dimensions
Postoperative dimension of the neovagina, measured by a measuring dilatator.
Measured: at 3 weeks, 3 months and 6 months post-operative
Clitoral sensation
patient assessed outcome, either none- less- normal or hyper
Measured: at 3 weeks, 3 months and 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start25 May 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rokitansky Kuster Hauser SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center prospective intervention study
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Mark-Bram Bouman, Amsterdam UMC, location VUmc
- Investigators
- Mark-Bram Bouman, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925361
- Sponsor's protocol ID
- NL80365
- Acronym
- PeriVaS
- Status last verified
- Jun 2023
- First submitted
- 7 Feb 2022
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28839860van 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.
PubMed 26632208Qin 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.
PubMed 27087418Jacoby 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.
PubMed 30707129Jun 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.
PubMed 34398096Salibian 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.
PubMed 33776039
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedicled Peritoneum Vaginoplasty in Feminizing Genital Surgery; Implementation According to IDEAL Framework
- ClinicalTrials.gov ID
- NCT05925361
- Acronym / sponsor ID
- PeriVaS / NL80365
- Conditions
- Rokitansky Kuster Hauser Syndrome, Vaginal Neoplasms, Gender Incongruence, Vaginal Obstruction, Penoscrotal Hypoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center prospective intervention study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: Laparoscopic pedicled single flap peritoneum vaginoplastyAll participants will undergo a laparoscopic single flap peritoneum vaginoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for vaginoplasty, with no option to use penoscrotal tissue or with shortage of penoscrotal tissue.
- Age >18
- Able to give informed consent
Key exclusion criteria (3 listed)
- Contra-indication for laparoscopic surgery
- Smoking (cessation for at least 6 weeks)
- BMI 18 < or >30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic pedicled single flap peritoneum vaginoplastyAfter 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. | Procedure or surgery | intervention |
Primary outcome
90 day postoperative complications. 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
Reported by full description of the event and eventual treatment and classified according to Clavien-Dindo classification.
9 secondary outcomes
Successful technical completion of operation
Time frame: From start of surgery until 90 days after
Operation time
Time frame: Intraoperative (From start of surgery up until closure of all wounds)
Blood loss
Time frame: Intraoperative (From start of surgery up until closure of all wounds)
Length of hospital stay
Time frame: From date of operation/intervention until the date of discharge or death, whichever came first, assessed up to 100 days
Sexual function
Time frame: at 12 months post-operation
Urinary function
Time frame: at 12 months post-operation
Post-operative pain
Time frame: at 3 weeks, 3 months and 6 months post-operative
Neovaginal dimensions
Time frame: at 3 weeks, 3 months and 6 months post-operative
Clitoral sensation
Time frame: at 3 weeks, 3 months and 6 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 28839860van 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.
- Background: PubMed 26632208van 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.
- Background: PubMed 27087418Qin 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.
- Background: PubMed 30707129Jacoby 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.
- Background: PubMed 34398096Jun 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.
- Background: PubMed 33776039Salibian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark-Bram Bouman, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic pedicled single flap peritoneum vaginoplasty in people with Rokitansky Kuster Hauser Syndrome and Vaginal Neoplasms, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marleen Vallinga, MD (+31204440162, m.s.vallinga@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 day postoperative complications. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925361, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.