Surgical Evaluation of Using the Prepuce in Feminizing Genitoplasty

NCT03897504 | Unknown

• 1 other identifier: N-100-2018
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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 Objectives : 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

Conditions

Congenital Adrenal Hyperplasia

Keywords

congenital adrenal hyperplasia; Feminizing genitoplasty; Vaginal stenosis

Outcome Measures

Primary Outcomes (1)

• vaginal size calibration

  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

  6 months to one year

Secondary Outcomes (1)

• urinary incontinence

  6 months

Study Arms (1)

feminizing genitoplasty using inner surface of the prepuce

EXPERIMENTAL

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

Interventions

feminizing genitoplasty using inner surface of the prepuce as pedicled tubularized flap PROCEDURE

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.

feminizing genitoplasty using inner surface of the prepuce

Eligibility Criteria

• Age: 18 Months - 14 Years
• Gender Eligibility Details: the study applicable only in over virilized females with congenital adrenal hyperplasia
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Females (46, XX genotype identified by karyotype
• Age: infants and children from 18 months old age to 14 years
• Virilized external genitalia.
• Persistent urogenital sinus
• Congenital adrenal hyperplasia.
• Controlled by glucocorticoid and mineralocorticoid replacement therapy and clinically and hormonally judged fit for surgical interventions.
• Voluntarily provided informed written consent of the parents for the planned procedure and possible risks.
• Informed written approval of the parents of the included children to use clinical data collected in a research program.

You may not qualify if:

• Male disorders of sexual development (46 XY)
• Debatable sex of rearing; Mixed gonadal dysgenesis, Ovotesticular disorders of sexual development and partial androgen insensitivity syndrome.
• Inadequate compliance with corticosteroid therapy, rendering surgery or interventions clinically hazardous or unsuitable.
• Inadequately controlled hormonal assay: elevated androgens.
• Patients who did any corrective surgery before.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

faculty of medicine- Cairo University

Cairo, El Manial, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

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: Assistant lecturer

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: March 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

EG (1)