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- Ensayo clínico NCT02538406
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.
26 de octubre de 2020 actualizado por: Mohamed Othman, Baylor College of Medicine
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial.
Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage.
During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps.
"Withdrawal time" is the period of time the doctor spends examining the colon.
Doctors usually spend six minutes examining the colon after they reach the end of the colon.
Studies have showed that spending more withdrawal time detects more lesions.
The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon.
There will be no other changes in the procedural aspect of the colonoscopy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Screening colonoscopy is an essential diagnostic tool in the early detection of precancerous colonic lesions, preventing the progression of these lesions to cancer.
Population-based and case control studies found a 50% reduction in colo-rectal cancer (CRC) incidence and up to a one-third reduction in mortality from CRC after screening colonoscopy.
The effectiveness of colonoscopy in preventing colon cancer is dependent on the adenoma detection rate (ADR) during the procedure.
Studies have demonstrated that withdrawal times of 6 minutes or more had higher rates of detection of any neoplasia.
In 2006 joint task force of the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy changed the recommendation to indicate that average withdrawal time should exceed 6 minutes in normal colonoscopies in which no polypectomies or biopsies were performed.
Based on this recommendation, the 6-minute benchmark is the current standard of care.
Longer mean withdrawal times are associated with increasing adenoma detection, mainly of small or right-sided adenomas and proximal serrated adenomas, presumably due to longer inspection of the right colon.
However, it also have been showed withdrawal time using 6 minutes as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator.
New CRC diagnosis within 3 years of negative screening colonoscopy can be as high as 6%.
Right-sided lesions, flat polyps, and variability in endoscopist quality measures are all potential reasons why interval cancers develop.
A recent observational study was published showing increase in ADR after implementation of a protocol of careful inspection during a minimum of 8 minutes was established.
The investigators hypothesized that if colonoscopists would spend at least half of the time of the withdrawal time in the right side of the colon (referred as segmented protocol), ADR can increase mainly due to the detection of lesions in the right side, which could have been missed otherwise.
The investigators are conducting a single center randomized trial investigating the utility of timed segmental withdrawal of at least 3 minutes each in both right and left side of the colon respectively, compared to the regular 6 minutes total withdrawal time regardless of where the time was spent in the colon.
Tipo de estudio
De observación
Inscripción (Actual)
232
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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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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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
Método de muestreo
Muestra de probabilidad
Población de estudio
Study participants will be recruited from patients ages 18-80 scheduled for a screening colonoscopy at Baylor College of Medicine.
Informed consent will be obtained from the patients during their Gastroenterology clinic visit if the procedure scheduled by gastroenterologist or during their pre-procedure assessment appointment if they were referred by a primary care doctor.
Participation in the study will be voluntary.
We use the split prep protocol in preparation for colonoscopy in all patients undergoing colonoscopy in our unit.
Descripción
Inclusion Criteria:
- Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.
Exclusion Criteria:
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
- Pregnant women
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
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
non segmental withdrawal
A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon.
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Segmental withdrawal
A standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes)
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Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Increase in detection rate of adenomas in the right side of the colon
Periodo de tiempo: 30 minutes
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To determine if timed segmental withdrawal protocol can increase the adenoma detection rate in the right side of the colon compared to non segmental withdrawal.
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30 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sessile Serrated lesion detection rate
Periodo de tiempo: 30 minutes
|
Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental withdrawal protocol and non-segmental withdrawal protocol.
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30 minutes
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mohamed O. Othman, MD, Baylor College of Medicine
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 2015
Finalización primaria (Anticipado)
1 de junio de 2020
Finalización del estudio (Actual)
2 de abril de 2020
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
1 de septiembre de 2015
Publicado por primera vez (Estimar)
2 de septiembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-37320
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .