RBR-76jbr5y Study on anatomical and histological changes of the prostate

Date of registration: 02/14/2023 ^(mm/dd/yyyy)
Last approval date : 02/14/2023 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1288-1500

• Public title:

  en

  Study on anatomical and histological changes of the prostate

  pt-br

  Estudo sobre alterações anatômicas e histológicas da próstata

• Scientific acronym:

  en

  pt-br

• Public acronym:
• Secondaries identifiers:
  • 62332522.6.1001.5505
    Issuing authority: Plataforma Brasil
  • 5.733.371
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de São Paulo

Sponsors

• Primary sponsor: Unifesp - Universidade Federal de São Paulo
• Secondary sponsor:
  • Institution: Unifesp - Universidade Federal de São Paulo
• Supporting source:
  • Institution: Unifesp - Universidade Federal de São Paulo

Health conditions

• Health conditions:

  en

  Prostatic Hyperplasia

  pt-br

  Hiperplasia prostática

• General descriptors for health conditions:

  en

  C12.100.500.565 Prostatic Diseases

  pt-br

  C12.100.500.565 Doenças Prostáticas

• Specific descriptors:

  en

  C12.100.500.565.500 Prostatic Hyperplasia

  pt-br

  C12.100.500.565.500 Hiperplasia Prostática

Interventions

• Interventions:

  en

  This is an observational, prospective cohort study. A group of 30 patients with Benign Prostatic Hyperplasia with symptoms of the lower urinary tract followed at the Discipline of Urology, Department of Surgery, Escola Paulista de Medicina, Universidade Federal de São Paulo, with symptoms refractory to drug treatment will undergo open transvesical prostatectomy ( when the prostate has an estimated weight greater than 80g). The surgical specimen will undergo in vitro resection, in a basin with saline solution, with a resectoscope, in order to simulate a Transurethral Resection of the Prostate (TURP). The weights of the surgical specimen will be compared before and after in vitro resection.

  pt-br

  Trata-se de um estudo observacional, coorte prospectiva. Um grupo de 30 pacientes com Hiperplasia Benigna da Próstata com sintomas do trato urinário inferior acompanhados na Disciplina de Urologia do Departamento de Cirurgia da Escola Paulista de Medicina da Universidade Federal de São Paulo, com sintomas refratários ao tratamento medicamentoso serão submetidos a prostatectomia transvesical aberta (quando a próstata tiver peso estimado superior a 80g). A peça cirúrgica será submetida a ressecção in vitro, em uma bacia com soro fisiológico, com ressectoscópio, de modo a simular uma Ressecção Transuretral da Próstata (RTUp). Serão comparados os pesos da peça cirúrgica antes e após a ressecção in vitro.

• Descriptors:

  en

  N40.1 Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms

  pt-br

  N40.1 Hiperplasia Benigna da Próstata com sintomas do trato urinário inferior

  en

  D08.811.277.656.300.760.442.750 Prostate-Specific Antigen

  pt-br

  D08.811.277.656.300.760.442.750 Antígeno Prostático Específico

  en

  E04.950.774.860.625 Prostatectomy

  pt-br

  E04.950.774.860.625 Prostatectomia

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 11/01/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  30	M	18 Y	90 Y

• Inclusion criteria:

  en

  Men; age between 18 and 90 years; with benign prostatic hyperplasia; refractory to drug treatment; consistent with surgical treatment

  pt-br

  Homens; idade entre 18 e 90 anos; com hiperplasia prostática benigna; refratário ao tratamento medicamentoso; concordante com o tratamento cirúrgico

• Exclusion criteria:

  en

  patients who refuse to undergo magnetic resonance imaging and those with infectious processes or suspected prostate cancer on examination that causes an anatomical and structural deformity of the gland

  pt-br

  recusar realizar a ressonância magnética; infecção urinária ativa; neoplasia de próstata suspeita acima de T3 (TNM)

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  It is expected to find a difference of more than 20% between the weight of the open transvesical prostatectomy surgical specimen and this same specimen after in vitro resection

  pt-br

  Espera-se encontrar uma diferença superior a 20% entre o peso da peça cirúrgica da prostatectomia tranvesical aberta e esta mesma peça após ressecção in vitro

• Secondary outcomes:

  en

  Secondary outcomes are not expected.

  pt-br

  Não são esperados desfechos secundários.

Contacts

• Public contact
  • Full name: André Barcelos Silva
  • • Address: Rua Napoleão de Barros, 715
    • City: Sao Paulo / Brazil
    • Zip code: 04024-000
  • Phone: +55 11 950585722
  • Email: andrebarcelossilva@gmail.com
  • Affiliation: Unifesp - Universidade Federal de São Paulo
   
• Scientific contact
  • Full name: Fernando Gonçalves Almeida
  • • Address: Rua Napoleão de Barros, 715
    • City: São Paulo / Brazil
    • Zip code: 04024-000
  • Phone: + 55 11 983860800
  • Email: Fernandourologia@hotmail.com
  • Affiliation: Unifesp - Universidade Federal de São Paulo
   
• Site contact
  • Full name: Paula Midori Castelo
  • • Address: Rua Botucatu 749
    • City: São Paulo / Brazil
    • Zip code: 04023-900
  • Phone: +55 11 975354978
  • Email: cep@unifesp.br
  • Affiliation: Unifesp - Universidade Federal de São Paulo
   

Additional links:

• Download in ICTRP format