Clinical trial NCT04195490: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Disorders of Sex Development
Keywords: feminizing genitoplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hussein F Ibrahim, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Tarek Sabra, MD
role: STUDY_DIRECTOR
References:
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