- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01035775
Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Thus, colonoscopy is typically performed by rapidly passing the instrument through the loops and bends of the colon in order to reach the tip of the cecum, and then performing a slow withdrawal in which the tip of the instrument is systematically deflected, and the mucosa is careful cleaned and suctioned, to expose all of the colonic mucosa for viewing.
Many experienced colonoscopists recognize that small polyps seen incidentally but not removed during insertion are sometimes quite difficult to find during withdrawal. The reason for this observation is probably because the colon is in a very different anatomical conformation during endoscope insertion and withdrawal. During insertion, the colon is in its natural conformation in which the sigmoid and transverse colon has several sharp bends or flexures, and the overall length has not yet been shortened. In this phase, the colon is often significantly stretched because of the formation of loops and bends in the colonoscope. This greatly affects the conformation of the colonic wall visualized proximal to the instrument tip. During withdrawal, the colon is shortened and pleated over the colonoscope, with successive regions of the colon being inspected as they slip off the end of the instrument. Thus, segments of visualized colon are often much straighter during withdrawal than during insertion. The insertion and withdrawal phases, therefore, expose somewhat different sections of the mucosal surface to the colonoscope and inspection on insertion and withdrawal are, quite possibly, complementary.
Aims: This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Study procedure: In this study, we plan to investigate whether a specified interval of inspection during insertion can increase overall adenoma detection. We will conduct a randomized controlled trial, in which patients will be randomized to have all of the inspection performed during the withdrawal phase (as is usual care) versus having several minutes of examination specifically devoted to inspection during insertion.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University Hospital
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Indianapolis, Indiana, Estados Unidos, 46280
- Beltway Surgery Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age ≥ 50 years
- Patients undergoing colonoscopy for screening or surveillance indications
Exclusion Criteria:
- Previous surgical resection of all or part of the colon.
- Inability to give informed consent.
- Ulcerative colitis or Crohn's disease.
- Polyposis syndrome or Lynch syndrome (HNPCC)
- Any comorbid condition which the investigator deems would put the patient at increased risk from a slightly prolonged procedure
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Insertion
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
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The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
|
|
Comparador Ativo: Withdrawal
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
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The colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum.
The instrument will be inserted to the cecum without deliberate inspection.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Adenoma detection rate
Prazo: During colonoscopy
|
During colonoscopy
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Sedation dose
Prazo: During colonoscopy
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During colonoscopy
|
|
Post procedural pain scores
Prazo: Within 1 hour of colonoscopy
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Within 1 hour of colonoscopy
|
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Proportion of patients with at least one adenoma detected
Prazo: During colonoscopy
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During colonoscopy
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Douglas K Rex, M.D., Indiana University School of Medicine
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0909-22
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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