RBR-9xg6dx Electronic Staining increases the Detection of Tumors of the Large Intestine and Rectum

Date of registration: 12/04/2018 ^(mm/dd/yyyy)
Last approval date : 12/04/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1219-8711

• Public title:

  en

  Electronic Staining increases the Detection of Tumors of the Large Intestine and Rectum

  pt-br

  Coloração Eletrônica aumenta a Deteccão de Tumores do Intestino Grosso e Reto

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 00385718.0.0000.5340
    Issuing authority: Plataforma Brasil
  • No. do parecer - 3.005.137
    Issuing authority: CEP - Universidade da Região da Campanha

Sponsors

• Primary sponsor: Santa Casa de Caridade de Bagé
• Secondary sponsor:
  • Institution: Santa Casa de Caridade de Bagé
• Supporting source:
  • Institution: Santa Casa de Caridade de Bagé

Health conditions

• Health conditions:

  en

  colorectal neoplasms

  pt-br

  neoplasias colorretais

• General descriptors for health conditions:

  en

  C04 Neoplasms

  pt-br

  C04 Neoplasias

  es

  C04 Neoplasias

• Specific descriptors:

Interventions

• Interventions:

  en

  Group 1:151 patients will be submitted to colonoscopy with use of linked color (LCI); Group 2: 150 patients will be submitted to colonoscopy with use of blue laser brght-mode (BLI-bright) and; Group 3: 150 patients will undergo colonoscopy with white light (WLI). The electronic chromoscopy technique used at each colonoscopy (in each patient) will be determined according to the randomization.

  pt-br

  Grupo 1: 151 pacientes serão submetidos à colonoscopia com uso de cor vinculada; grupo 2: 150 pacientes serão submetidos à colonoscopia com uso de laser azul modo brilhante; e, grupo 3: 150 pacientes serão submetidos à colonoscopia com luz branca. A técnica de cromoscopia eletrônica utilizada em cada colonoscopia (em cada paciente) será determinada de acordo com a randomização.

• Descriptors:

  en

  E01.370.372.250.250.200 Colonoscopy

  pt-br

  E01.370.372.250.250.200 Colonoscopia

  es

  E01.370.372.250.250.200 Colonoscopía

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 11/08/2018 ^(mm/dd/yyyy)
• Date last enrollment: 02/03/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  451	-	30 Y	80 Y

• Inclusion criteria:

  en

  Adults aged 30 years or older who present symptoms such as altered bowel habit; abdominal pain or discomfort; abdominal distension and rectal bleeding; adequate bowel preparation; complete colonoscopy and; who were referred for screening or surveillance.

  pt-br

  Adultos com idade igual ou maior que 30 anos que apresentem sintomas como hábito intestinal alterado; dor ou desconforto abdominal; distensão abdominal e sangramento retal; preparo intestinal adequado; colonoscopia completa; e, que tenham sido encaminhados para triagem ou vigilância.

• Exclusion criteria:

  en

  Age less than 30 years; advanced colorectal cancer; use of antithrombotic therapy; inflammatory bowel disease;previous colorectal resection; presence of adenomas diagnosed in a previous colonoscopy; acute lower gastrointestinal bleeding; inadequate bowel preparation; or incomplete colonoscopy.

  pt-br

  Idade menor que 30 anos; câncer colorretal avançado; uso de terapia antitrombótica; doença inflamatória intestinal; ressecção colorretal prévia; presença de adenomas diagnosticados em uma colonoscopia prévia; sangramento gastrointestinal inferior agudo; preparo intestinal inadequado; colonoscopia incompleta.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Diagnostic	Parallel	3	Open	Randomized-controlled	4

Outcomes

• Primary outcomes:

  en

  Adenoma detection rate, evaluated by the techniques of linked color imaging (LCI), white light imaging (WLI) and blue laser imaging (BLI-bright) and confirmed by a blinded pathologist within 7 days of the colonoscopy.

  pt-br

  Taxa de detecção de adenomas colorretais, avaliado pelas técnicas de linked color imaging (LCI), white light imaging (WLI) e blue laser imaging (BLI-brilhante) e confirmados por patologista cegado em até 7 dias da realização da colonoscopia.

• Secondary outcomes:

  en

  Number of adenomas per patient, evaluated by the number of polyps removed during the colonoscopy of each patient, whose histology confirmed the diagnosis of adenoma, about 7 days after the colonoscopy. Colonoscope withdrawal time evaluated in minutes from the cecum to the anal margin.

  pt-br

  Número de adenomas por paciente, avaliado pelo número de pólipos retirados durante a colonoscopia de cada paciente, cuja histologia confirmava o diagnóstico de adenoma, cerca de 7 dias após a realização da colonoscopia. Tempo de retirada do colonoscópio avaliado em minutos a partir do ceco até a margem anal.

Contacts

• Public contact
  • Full name: Carlos Eduardo Oliveira dos Santos
  • • Address: Rua Gomes Carneiro, 1343
    • City: Bagé / Brazil
    • Zip code: 96400-130
  • Phone: +555399715710
  • Email: ddendo@uol.com.br
  • Affiliation: Santa Casa de Caridade de Bagé
   
• Scientific contact
  • Full name: Carlos Eduardo Oliveira dos Santos
  • • Address: Rua Gomes Carneiro, 1343
    • City: Bagé / Brazil
    • Zip code: 96400-130
  • Phone: +555399715710
  • Email: ddendo@uol.com.br
  • Affiliation: Santa Casa de Caridade de Bagé
   
• Site contact
  • Full name: Daniele Malaman
  • • Address: Rua Gomes Carneiro, 1343
    • City: Bagé / Brazil
    • Zip code: 96400-130
  • Phone: +555399715710
  • Email: daniele.malaman@hotmail.com.br
  • Affiliation: Santa Casa de Caridade de Bagé
   

Additional links:

• Download in ICTRP format