Surgical Evaluation of Using the Prepuce in Feminizing Genitoplasty
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|ClinicalTrials.gov Identifier: NCT03897504|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Background and Rationale: The vaginoplasty remains a challenge for the surgeon. The most commonly used techniques have been: the Y-V plasty described by fortunoff for low vagina, the pullthrough operation described by Hendren and Crawford for high vagina, and the passerini-Glazer technique . None of these procedures is entirely satisfactory; with the first two, the neovagina has a tendency to become stenotic in most cases. Moreover, in the third, in addition to the high rate of stenosis, which is encountered in a third of case , the high rate of urethro-vaginal fistulas is unacceptable
To describe and evaluate a surgical technique for vaginoplasty that is easy to realize with fewer complications especially vaginal stenosis.
Study population & Sample size : 24 patients suffering from congenital adrenal hyperplasia (CAH) presenting to outpatient clinic of diabetis Endocrine And Metabolism Pediatric Unit (DEMPU) of Cairo University Specialized Pediatric Hospital will be considered.
Study Design : non-controlled prospective clinical trial with all patients included in single group
Methods: Cystoscopy will be done promptly before proceeding to surgery, Confluence depth more than 20 mm is considered high anomaly, feminizing genitoplasty will be done as a one-stage procedure, One month after operation, examination under anesthesia will be done with calibration of vagina.
Possible Risk (s) to study population : The risk of this study is involving a vulnerable group of females which exposed to lengthy operation may complicate with bleeding and need for blood transfusion, infection early after surgery or vaginal stenosis.
Outcome parameter (s):
Vaginal calibration using hegars dilators Urodynamics for females older than 3 years and complaining from incontinence
|Condition or disease||Intervention/treatment||Phase|
|Congenital Adrenal Hyperplasia||Procedure: feminizing genitoplasty using inner surface of the prepuce as pedicled tubularized flap||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgical Evaluation Of Using The Inner Surface Of The Prepuce In Feminizing Genitoplasty In Cases Of Verilized Females With Congenital Adrenal Hyperplasia|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Experimental: feminizing genitoplasty using inner surface of the prepuce
Feminizing genitoplasty will be done using the prepuce as a pedicled tubularized flap to create the new vagina, the new vagina which the investigators create it from the prepuce will be sutured above to the native vagina after its separation from the urogenital sinus, and the remaining part of the urogenital sinus will be used to create the urethra, the remaining part of the prepuce will create the labia minora, clitoroplasty will be attempted in all patients.
Procedure: feminizing genitoplasty using inner surface of the prepuce as pedicled tubularized flap
the prepuce of the females with congenital adrenal hyperplasia will be tubularized and used as pedicled flap in creating the new vagina, the urethra will be completed with the urogenital sinus, no mobilization either partial or complete urogenital mobilization will be needed in cases with low and intermediate confluence level (less than 30 mm), in case with high confluence (more than 30 mm) laparoscopic vaginal pullthrough will be attempted first then the same previously described technique will be applied, the depth of the confluence will be determined before starting surgery by doing genitograph under general anaesthesia, stent will be kept in the new vagina for 5 days and further scheduled calibrations and dilatations will be applied regularly with paying attention to urinary complications like incontinence and urethrovaginal fistula by doing urodynamics and micturating cystourethrogram if there is a complain.
- vaginal size calibration [ Time Frame: 6 months to one year ]the new vagina will be assessed for stenosis 1 month after the procedure using Hegar dilators under general anaesthesia, further calibration will be done over 6 months to ensure patency of the vagina and to avoid stenosis by dilatation if stenosis encountered
- urinary incontinence [ Time Frame: 6 months ]in patient older than 3 years and complaining from incontinence, urodynamics will be done.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897504
|faculty of medicine- Cairo University||Recruiting|
|Cairo, El Manial, Egypt, 12613|
|Contact: Mahmoud T Mohammed, assistan lecturer 01111830411 ext 002 Mahmoud.firstname.lastname@example.org|
|Contact: Ahmed K weshahi, lecturer 01095227442 ext 002 email@example.com|
|Principal Investigator: Hesham M Elsaket, professor|
|Principal Investigator: khaled H Bahaa Eldin, professor|
|Principal Investigator: Hend M Abdel Latif, professor|
|Principal Investigator: Ahmed K Weshahi, lecturer|
|Principal Investigator: Mahmoud T Mohamed, assistant lecturer|