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

NCT04195490 | Unknown

• 1 other identifier: disorders of sex development
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Disorders of Sex Development

Keywords

feminizing genitoplasty

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (1)

children with disorders of sex development

OTHER

children with disorders of sex development needing feminizing genitoplasty

Procedure: feminizing genitoplasty

Interventions

feminizing genitoplasty PROCEDURE

feminizing genitoplasty including vaginoplasty,clitroplasty, labioplasty and urethroplasty

children with disorders of sex development

Eligibility Criteria

• Age: 18 Months - 14 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 16882788 BACKGROUND

• 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.

  PMID: 20650476 BACKGROUND

• 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.

  PMID: 20823466 BACKGROUND

• 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.

  PMID: 16947028 BACKGROUND

• 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.

  PMID: 19675521 BACKGROUND

• 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.

  PMID: 14597017 BACKGROUND

• 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.

  PMID: 19231546 BACKGROUND

• 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.

  PMID: 12205281 BACKGROUND

MeSH Terms

Conditions

Disorders of Sex Development

Condition Hierarchy (Ancestors)

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; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Hussein F Ibrahim, Msc

  Assiut University

  PRINCIPAL INVESTIGATOR

• Tarek Sabra, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Hussein Ibrahim, Msc

CONTACT

01097675971; husinfarah28@gmail.com

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: December 3, 2019
• First Posted: December 12, 2019
• Study Start: April 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: February 20, 2022
• Last Updated: December 12, 2019

Record last verified: 2019-12