Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
25 de agosto de 2016 actualizado por: Yanglin Pan, Air Force Military Medical University, China
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study
Patients with colorectal adenomas are suggested to receive polypectomy.
A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy.
And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy.
The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.
For the AI method, water was not used, and air was insufflated during insertion.
Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
450
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710032
- Reclutamiento
- Endoscopic center, Xijing Hospital of Digestive Diseases
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Contacto:
- Gui Ren, MD
- Número de teléfono: +862984771536
- Correo electrónico: renguigz@hotmail.com
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Investigador principal:
- Gui Ren, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 18-80 patients undergoing selective polypectomy
Exclusion Criteria:
- Polyps found more than 6 months
- Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
- Patients with history of inflammatory bowel disease
- Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
- Patients not undergoing standard bowel preparation
- Patients with solid feces in the last stool after bowel preparation
- Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
- Hemodynamically unstable
- Pregnant women
- Unable to provide informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum.
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Water exchange (WE) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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Comparador activo: Air insufflation (AI) method
Air insufflation (AI) method was used for insertion to the cecum.
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Air insufflation (AI) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adenoma miss rate
Periodo de tiempo: 12 months
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Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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adenoma-level miss rate
Periodo de tiempo: 12 months
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Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
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12 months
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Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy
Periodo de tiempo: 12 months
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Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
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12 months
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Adenoma per positive patient (APP)
Periodo de tiempo: 12 months
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The mean number of adenoma per positive patient
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12 months
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Quality of Bowel Preparation
Periodo de tiempo: 12 months
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The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
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12 months
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Complication rate
Periodo de tiempo: 12 months
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Bleeding, perforation and others
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12 months
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Pain Scores on the Visual Analog Scale compared with previous colonoscopy
Periodo de tiempo: 12 months
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0 = no pain, to 10 = most severe pain
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12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.
- Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.
- Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2016
Finalización primaria (Anticipado)
1 de agosto de 2017
Finalización del estudio (Anticipado)
1 de agosto de 2017
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2016
Publicado por primera vez (Estimar)
26 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de agosto de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY20162059-2
Plan de datos de participantes individuales (IPD)
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INDECISO
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