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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
Sponsor:
Information provided by (Responsible Party):
Mahmoud Tarek Mohamed Bahget, Kasr El Aini Hospital

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


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. urinary incontinence [ Time Frame: 6 months ]
    in patient older than 3 years and complaining from incontinence, urodynamics will be done.



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Ages Eligible for Study:   18 Months to 14 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   the study applicable only in over virilized females with congenital adrenal hyperplasia
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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Egypt
faculty of medicine- Cairo University Recruiting
Cairo, El Manial, Egypt, 12613
Contact: Mahmoud T Mohammed, assistan lecturer    01111830411 ext 002    Mahmoud.tarek@kasralainy.edu.eg   
Contact: Ahmed K weshahi, lecturer    01095227442 ext 002    ahmed.kadry@kasralainy.edu.eg   
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         
Sponsors and Collaborators
Kasr El Aini Hospital

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Responsible Party: Mahmoud Tarek Mohamed Bahget, Assistant lecturer, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03897504     History of Changes
Other Study ID Numbers: N-100-2018
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Tarek Mohamed Bahget, Kasr El Aini Hospital:
congenital adrenal hyperplasia
Feminizing genitoplasty
Vaginal stenosis
Additional relevant MeSH terms:
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Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Hyperplasia
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents