RBR-4fzby4 Evaluation of the incision of the layer that covers the testis and reconstruction using a vaginal tunica flap in acute…

Date of registration: 07/28/2020 ^(mm/dd/yyyy)
Last approval date : 07/28/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1252-9347

• Public title:

  en

  Evaluation of the incision of the layer that covers the testis and reconstruction using a vaginal tunica flap in acute Testicular torsion

  pt-br

  Avaliação da incisão da camada que recobre o testículo e reconstrução com retalho de túnica vaginal na Torção testicular aguda

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 03049018.2.0000.5479
    Issuing authority: Plataforma Brasil
  • 3.088.961
    Issuing authority: Comitê de Ética em Pesquisa da Santa Casa da Misericórdia de São Paulo

Sponsors

• Primary sponsor: Santa Casa de São Paulo
• Secondary sponsor:
  • Institution: Santa Casa de São Paulo
• Supporting source:
  • Institution: Santa Casa de São Paulo

Health conditions

• Health conditions:

  en

  Acute testicular torsion

  pt-br

  Torção testicular aguda

• General descriptors for health conditions:

  en

  N00-N99 XIV - Diseases of the genitourinary system

  pt-br

  N00-N99 XIV - Doenças do aparelho geniturinário

• Specific descriptors:

Interventions

• Interventions:

  en

  Intervention group: 7 participants who presented at the emergency and were diagnosed with acute testicular torsion. They will be submitted to decompressive albugineotomy and reconstruction using a vaginal tunic flap in order to reduce the compartment syndrome and assess whether there is better testicular preservation with this technique. Patients will be followed up with testicles ultrasound of control in 3 and 6 months. Control group: 7 participants who arrived at the emergency room and were diagnosed with acute testicular torsion. They will be submitted to a standard approach consisting of orchidopexy in case of viability or orchiectomy if the testis is not viable. Patients will be followed up with testicles ultrasound of control in 3 and 6 months.

  pt-br

  Grupo intervenção: 7 participantes que chegaram ao pronto socorro e forem diagnosticados com torção testicular aguda. Serão submetido a albugineotomia descompressiva e reconstrução com retalho de túnica vaginal com o objetivo de diminuir a síndrome compartimental e avaliar se há melhor preservação testicular com esta técnica. Os paciente serão acompanhandos com ultrassom de testículos controle em 3 e 6 meses. Grupo controle: 7 participantes que chegaram ao pronto socorro e forem diagnosticados com torção testicular aguda. Serão submetido a abordagem padrão que consiste em orquidopexia em caso de viabilidade ou orquiectomia caso o testículo esteja inviável. Os paciente serão acompanhandos com ultrassom de testículos controle em 3 e 6 meses.

• Descriptors:

  en

  C12.294.693 Spermatic Cord Torsion

  pt-br

  C12.294.693 Torção do Cordão Espermático

  es

  C12.294.693 Torsión del Cordón Espermático

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 12/01/2018 ^(mm/dd/yyyy)
• Date last enrollment: 12/20/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  14	M	14 Y	30 Y

• Inclusion criteria:

  en

  Patients diagnosed with acute testicular torsion

  pt-br

  Pacientes diagnosticados com torção testicular aguda

• Exclusion criteria:

  en

  Bilateral testicular torsion Testicular torsion in a patient with a single testis

  pt-br

  Torção testicular bilateral Torção testicular em paciente com testículo único

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  It is expected to find greater testicular preservation in the intervention group; using testicular size and doppler flow as a method in control ultrasounds with 3 and 6 months of follow-up. The affected testicles with a size greater than 50% of the testis contralateral (not affected) and with doppler flow will be considered preserved.

  pt-br

  Espera-se encontrar maior preservação testicular no grupo intervenção; utilizando como método o tamanho testicular e fluxo ao doppler nas ultrassonografias de controle com 3 e 6 meses de seguimento. Os testículo acometidos e com tamanho maior que 50% do testículo contra lateral(não acometido) e com fluxo ao doppler serão considerados preservados.

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Rafael Ribeiro Zanotti
  • • Address: Rua Dr. Cesário Mota Junior, numero 112
    • City: São Paulo / Brazil
    • Zip code: 01221--01
  • Phone: +55-011-997923100
  • Email: rafael_r_z@hotmail.com
  • Affiliation: Santa Casa de São Paulo
   
• Scientific contact
  • Full name: Rafael Ribeiro Zanotti
  • • Address: Rua Dr. Cesário Mota Junior, numero 112
    • City: São Paulo / Brazil
    • Zip code: 01221--01
  • Phone: +55-011-997923100
  • Email: rafael_r_z@hotmail.com
  • Affiliation: Santa Casa de São Paulo
   
• Site contact
  • Full name: Rafael Ribeiro Zanotti
  • • Address: Rua Dr. Cesário Mota Junior, numero 112
    • City: São Paulo / Brazil
    • Zip code: 01221--01
  • Phone: +55-011-997923100
  • Email: rafael_r_z@hotmail.com
  • Affiliation: Santa Casa de São Paulo
   

Additional links:

• Download in ICTRP format