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