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Evaluation of Outcomes of Feminizing Genitoplasty in Children With Disorders of Sex Development

Primary Purpose

Disorders of Sex Development

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
feminizing genitoplasty
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorders of Sex Development focused on measuring feminizing genitoplasty

Eligibility Criteria

18 Months - 14 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age : infants and children from 18 months old age to 14 years.
  2. virilized external genitalia.

Exclusion Criteria:

  • (1)children who did any corrective genitoplasty before. (2)children with debatable sex of rearing;ovotesticular DSD, mixed gonadal dysgenesis and partial androgen insensitivity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    children with disorders of sex development

    Arm Description

    children with disorders of sex development needing feminizing genitoplasty

    Outcomes

    Primary Outcome Measures

    The vaginal size will be evaluated for stenosis within 6 months after the procedure using Hegar dilators under general anaesthesia to ensure patency of the vagina.
    The incidence of unsatisfied cosmetic results after feminizing genitoplasty

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2019
    Last Updated
    December 11, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04195490
    Brief Title
    Evaluation of Outcomes of Feminizing Genitoplasty in Children With Disorders of Sex Development
    Official Title
    Evaluation of the Outcomes of Feminizing Genitoplasty in Children With Disorders of Sex Development
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    February 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Evaluate the short term outcomes of feminizing genitoplasty including vaginoplasty,clitroplasty, labioplasty and urethroplasty in children with disorders of sex development as regarding cosmetic and functional aspects.
    Detailed Description
    Disorders of sex development (DSD) are a wide range of congenital conditions characterized by incongruent development of the components involved in sex differentiation including chromosomes, gonads, brain and anatomic sex.Sex assignment is a critical aspect in management of DSD and it is determined by investigations, genital appearance, fertility potential and cultural practices and pressurs. It is recommended that genital surgery for a child raised as a female considered only in cases of severe virilization (Prader 3-5) and that surgery for the clitoris not be performed for reasons of cosmesis only.Feminizing genital reconstruction has evolved considerably over the past decades as a result of improved understanding of anatomy , modification of surgical procedures and audit of outcomes. For patients with congenital adrenal hyperplasia (CAH) with severe virilization raised as a female , it is recommended that clitorial and perineal reconstruction be considered in infancy and those with a low vaginal confluence undergo vaginoplasty at an early age , the appropriate timing for those with higher vaginal confluence is still less certain. Cosmetic outcomes after genitoplasty are variable. Most studies have detected only functional and cosmetic outcomes rated by the physician, but satisfaction ratings may differ between physicians and patients or their parents . The present prospective , interventional study aimed to describe the frequency of sex assignment and types of surgery performed in a cohort of patients with moderate to severe genital ambiguity and also evaluate surgical outcomes of feminizing genitoplasty in these patients .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorders of Sex Development
    Keywords
    feminizing genitoplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    children with disorders of sex development
    Arm Type
    Other
    Arm Description
    children with disorders of sex development needing feminizing genitoplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    feminizing genitoplasty
    Intervention Description
    feminizing genitoplasty including vaginoplasty,clitroplasty, labioplasty and urethroplasty
    Primary Outcome Measure Information:
    Title
    The vaginal size will be evaluated for stenosis within 6 months after the procedure using Hegar dilators under general anaesthesia to ensure patency of the vagina.
    Description
    The incidence of unsatisfied cosmetic results after feminizing genitoplasty
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age : infants and children from 18 months old age to 14 years. virilized external genitalia. Exclusion Criteria: (1)children who did any corrective genitoplasty before. (2)children with debatable sex of rearing;ovotesticular DSD, mixed gonadal dysgenesis and partial androgen insensitivity.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hussein Ibrahim, Msc
    Phone
    01097675971
    Ext
    +20
    Email
    husinfarah28@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hussein F Ibrahim, Msc
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Tarek Sabra, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16882788
    Citation
    Lee PA, Houk CP, Ahmed SF, Hughes IA; International Consensus Conference on Intersex organized by the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology. Consensus statement on management of intersex disorders. International Consensus Conference on Intersex. Pediatrics. 2006 Aug;118(2):e488-500. doi: 10.1542/peds.2006-0738. No abstract available.
    Results Reference
    background
    PubMed Identifier
    20650476
    Citation
    Sircili MH, e Silva FA, Costa EM, Brito VN, Arnhold IJ, Denes FT, Inacio M, de Mendonca BB. Long-term surgical outcome of masculinizing genitoplasty in large cohort of patients with disorders of sex development. J Urol. 2010 Sep;184(3):1122-7. doi: 10.1016/j.juro.2010.05.022. Epub 2010 Jul 21.
    Results Reference
    background
    PubMed Identifier
    20823466
    Citation
    Speiser PW, Azziz R, Baskin LS, Ghizzoni L, Hensle TW, Merke DP, Meyer-Bahlburg HF, Miller WL, Montori VM, Oberfield SE, Ritzen M, White PC; Endocrine Society. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Sep;95(9):4133-60. doi: 10.1210/jc.2009-2631. Erratum In: J Clin Endocrinol Metab. 2010 Nov;95(11):5137. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2853.
    Results Reference
    background
    PubMed Identifier
    16947028
    Citation
    Gupta DK, Shilpa S, Amini AC, Gupta M, Aggarwal G, Deepika G, Kamlesh K. Congenital adrenal hyperplasia: long-term evaluation of feminizing genitoplasty and psychosocial aspects. Pediatr Surg Int. 2006 Nov;22(11):905-9. doi: 10.1007/s00383-006-1765-x.
    Results Reference
    background
    PubMed Identifier
    19675521
    Citation
    Oswiecimska JM, Paradysz A, Zyczkowski M, Ziora KT, Pikiewicz-Koch A, Stojewska M, Dyduch A. Effects of feminizing surgery for ambiguous genitalia - a novel scale for evaluation of cosmetic and anatomical results. Neuro Endocrinol Lett. 2009;30(2):262-7.
    Results Reference
    background
    PubMed Identifier
    14597017
    Citation
    Stikkelbroeck NM, Beerendonk CC, Willemsen WN, Schreuders-Bais CA, Feitz WF, Rieu PN, Hermus AR, Otten BJ. The long term outcome of feminizing genital surgery for congenital adrenal hyperplasia: anatomical, functional and cosmetic outcomes, psychosexual development, and satisfaction in adult female patients. J Pediatr Adolesc Gynecol. 2003 Oct;16(5):289-96. doi: 10.1016/s1083-3188(03)00155-4.
    Results Reference
    background
    PubMed Identifier
    19231546
    Citation
    Crawford JM, Warne G, Grover S, Southwell BR, Hutson JM. Results from a pediatric surgical centre justify early intervention in disorders of sex development. J Pediatr Surg. 2009 Feb;44(2):413-6. doi: 10.1016/j.jpedsurg.2008.10.101.
    Results Reference
    background
    PubMed Identifier
    12205281
    Citation
    Migeon CJ, Wisniewski AB, Gearhart JP, Meyer-Bahlburg HF, Rock JA, Brown TR, Casella SJ, Maret A, Ngai KM, Money J, Berkovitz GD. Ambiguous genitalia with perineoscrotal hypospadias in 46,XY individuals: long-term medical, surgical, and psychosexual outcome. Pediatrics. 2002 Sep;110(3):e31. doi: 10.1542/peds.110.3.e31.
    Results Reference
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    Evaluation of Outcomes of Feminizing Genitoplasty in Children With Disorders of Sex Development

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