Public trial
RBR-10t84b5s Clinical outcomes and costs of the use of Fibrin Glue in Pancreatic Surgery
Date of registration: 04/05/2021 (mm/dd/yyyy)Last approval date : 04/05/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Impact of the use of Fibrin biological glue sealant on the reinforcement of Pancreatic anastomosis after Duodenopancreatectomy
pt-br
Impacto do uso de Selante cola biológica de Fibrina no reforço da Anastomose Pancreática após Duodenopancreatectomias
es
Impact of the use of Fibrin biological glue sealant on the reinforcement of Pancreatic anastomosis after Duodenopancreatectomy
Trial identification
- UTN code:
-
Public title:
en
Clinical outcomes and costs of the use of Fibrin Glue in Pancreatic Surgery
pt-br
Impacto nos resultados clínicos e nos custos hospitalares do emprego da cola de fibrina em cirurgias pancreáticas
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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U1111-1262-0305
Issuing authority: WHO
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26745614.4.0000.5440
Issuing authority: Plataforma Brasil
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723520
Issuing authority: Hospital das Clinicas da faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
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U1111-1262-0305
Sponsors
- Primary sponsor: Hospital das Clínicas Faculdade de Medicina Ribeirão Preto
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Secondary sponsor:
- Institution: Hospital das Clínicas Faculdade de Medicina Ribeirão Preto
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Supporting source:
- Institution: Hospital das Clínicas Faculdade de Medicina Ribeirão Preto
Health conditions
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Health conditions:
en
Pancreaticoduodenectomy; pancreatic fistula
pt-br
Pancreaticoduodenectomia; fístula pancreática
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General descriptors for health conditions:
en
C04.588.274.761 Pancreatic Neoplasms
pt-br
C04.588.274.761 Neoplasias Pancreáticas
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Specific descriptors:
en
E04.210.760 Pancreaticoduodenectomy
pt-br
E04.210.760 Pancreaticoduodenectomia
en
C06.267.775 Pancreatic Fistula
pt-br
C06.267.775 Fístula Pancreática
Interventions
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Interventions:
en
The present study was based on a retrospective collection of data from medical records of patients submitted to pancreaticoduodenectomy (with or without pylorus preservation), treated consecutively by the same team of surgeons between 2007 and 2012, regardless of the disease that prompted the procedure. Experimental group: 31 patients undergoing duodenopancreatectomy using fibrin sealant topically in pancreatic-jejunal anastomosis Control group: 31 patients undergoing duodenopancreatectomy without application of fibrin sealant topically in pancreatic-jejunal anastomosis
pt-br
O presente estudo foi realizado a partir da coleta retrospectiva dos dados de prontuários de pacientes submetidos a duodenopancreatectomia (com ou sem preservação pilórica), tratados consecutivamente, pela mesma equipe de cirurgiões, de maio de 2007 até abril de 2012, independente da doença que motivou o procedimento. Grupo experimental: 31 pacientes submetidos a duodenopancreatectomia com aplicação do selante de fibrina topicamente na anastomose pancreato-jejunal Grupo controle: 31 pacientes submetidos a duodenopancreatectomia sem aplicação do selante de fibrina topicamente na anastomose pancreato-jejunal
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Descriptors:
en
D12.776.124.270.305 Fibrin Tissue Adhesive
pt-br
D12.776.124.270.305 Adesivo Tecidual de Fibrina
Recruitment
- Study status: Data analysis completed
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Countries
- Brazil
- Date first enrollment: 02/01/2011 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 62 - 0 0 -
Inclusion criteria:
en
both sexes; any age; undergoing duodenopancreatectomy
pt-br
ambos sexos; qualquer idade; submetidos a duodenopancreatectomia
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Exclusion criteria:
en
There is not
pt-br
não há
Study type
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Study design:
en
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Prevention Parallel 2 Single-blind Non-randomized-controlled N/A
Outcomes
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Primary outcomes:
en
decreased incidence of postoperative pancreatic fistula
pt-br
diminuição da incidência de fístula pancreática pós operatória
en
decrease in postoperative complications
pt-br
diminuição nas complicações pós operatórias
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Secondary outcomes:
en
decrease in hospital costs
pt-br
diminuição dos custos hospitalares
en
decrease in length of hospital stay
pt-br
diminuição no tempo de internação hospitalar
Contacts
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Public contact
- Full name: Alberto Facury Gaspar
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- Address: Rua Rodolfo Coelho Cavalcanti 80 casa 10
- City: ribeirão preto / Brazil
- Zip code: 14028566
- Phone: +5516981395000
- Email: afgasp@hotmail.com
- Affiliation:
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Scientific contact
- Full name: Alberto Facury Gaspar
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- Address: Rua Rodolfo Coelho Cavalcanti 80 casa 10
- City: ribeirão preto / Brazil
- Zip code: 14028566
- Phone: +5516981395000
- Email: afgasp@hotmail.com
- Affiliation:
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Site contact
- Full name: Alberto Facury Gaspar
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- Address: Rua Rodolfo Coelho Cavalcanti 80 casa 10
- City: ribeirão preto / Brazil
- Zip code: 14028566
- Phone: +5516981395000
- Email: afgasp@hotmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 10142.
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