Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
4 de noviembre de 2015 actualizado por: Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating.
Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain.
This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure.
Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure.
Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure.
Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores.
Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.
Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge.
The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2.
The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2.
The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Tipo de estudio
Intervencionista
Inscripción (Actual)
246
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
-
-
California
-
Los Angeles, California, Estados Unidos, 91343
- Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
-
-
-
-
CI
-
Iglesias, CI, Italia, 09016
- Digestive Endoscopy Unit, Ospedale S. Barbara
-
-
-
-
-
Ostrava, República Checa, 703 84
- Digestive Diseases Center, Vìtkovice Hospital
-
-
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:
- consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication
Exclusion Criteria:
- patient unwillingness to start the procedure without sedation/analgesia
- previous colorectal surgery
- proctosigmoidoscopy or bidirectional endoscopy
- patient refusal or inability to provide informed consent
- inadequate consumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
- history of inflammatory bowel disease
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
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Carbon dioxide method
Colonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration.
Washing allowed as needed.
Considered to be standard procedure.
|
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
|
|
Experimental: Water Exchange-CO2
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using carbon dioxide insufflation.
|
Insertion using water exchange, withdrawal using CO2 insufflation.
|
|
Experimental: Water Exchange-AI
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using air insufflation.
|
Insertion using water exchange, withdrawal using air insufflation.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in abdominal bloating sensation after colonoscopy.
Periodo de tiempo: Within the first 24 hours after the procedure.
|
Change of patients' sensation of abdominal bloating.
Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients.
Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating.
Results will be recorded by telephone recall.
|
Within the first 24 hours after the procedure.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in pain score after colonoscopy.
Periodo de tiempo: Within the first 24 hours after the procedure.
|
Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients.
Measured using an eleven-point NRS (0=none, 10=maximum pain).
Results will be recorded by telephone recall.
|
Within the first 24 hours after the procedure.
|
|
Real-time insertion pain.
Periodo de tiempo: 1 hour.
|
Pain assessed using a NRS (0=absence of pain, 2=simply "discomfort", 10=worst pain).
Before the procedure, an endoscopic nurse will explain the NRS scoring system to the patients.
At irregular intervals during colonoscopy (around 60 seconds) assisting nurse will ask patients about discomfort or pain.
The responses will be recorded, and the maximum pain score noted.
Colonoscopists not participating in gathering the informations.
|
1 hour.
|
|
Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
Periodo de tiempo: 6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Number of flatus episodes post-procedure.
Periodo de tiempo: 24 hours.
|
Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
24 hours.
|
|
Number of incontinence episodes post-procedure.
Periodo de tiempo: 6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Toilet use for bowel movement post-procedure.
Periodo de tiempo: 6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Patients' satisfaction with the procedure.
Periodo de tiempo: 24 hours.
|
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not satisfied, 10=very satisfied).
Results will be recorded by telephone recall.
|
24 hours.
|
|
Willingness to repeat colonoscopy.
Periodo de tiempo: 24 hours.
|
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not willing to repeat, 10=very likely to repeat).
Results will be recorded by telephone recall.
|
24 hours.
|
|
Interference of colonoscopy on work/normal activities the same day of the procedure.
Periodo de tiempo: Up to 12 hours.
|
Assessed post-procedure after 12 hours using a questionnaire given to patients (0=nothing at all, 10=a lot).
Results will be recorded by telephone recall.
|
Up to 12 hours.
|
|
Day of work missed the day after the procedure.
Periodo de tiempo: 24 hours.
|
Work activities missed the day after colonoscopy due to some effect of the procedure (yes, no).
Assessed post-procedure after 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
24 hours.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cecal intubation rate.
Periodo de tiempo: 1 hour.
|
Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.
|
1 hour.
|
|
Cecal intubation time.
Periodo de tiempo: 1 hour.
|
Defined as the time for passage of the colonoscope from the rectum to the cecum.
|
1 hour.
|
|
Total procedure time.
Periodo de tiempo: 1 hour.
|
Total procedure time (including time required for water infusion, polyp resection or biopsy).
|
1 hour.
|
|
Adenoma detection rate.
Periodo de tiempo: 9 months.
|
Proportion of subjects with at least one adenoma of any size.
|
9 months.
|
|
On-demand sedation.
Periodo de tiempo: 1 hour.
|
Offered at patient request for a NRS score ≥2.
Medications given as per institutional regulation.
Dose titrated based on patients' reported real-time pain score, age, weight and comorbidity.
|
1 hour.
|
|
Oxygen desaturation.
Periodo de tiempo: 1 hour.
|
Significant oxygen desaturation (<85% for >15 seconds) will be recorded.
|
1 hour.
|
|
Vagal reaction.
Periodo de tiempo: 1 hour.
|
Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.
|
1 hour.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sergio Cadoni, MD, S. Barbara Hospital, Iglesias (CI) Italy
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
- Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
- Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.
- de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
- Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.
- Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
- Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.
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 abril de 2015
Finalización primaria (Actual)
1 de noviembre de 2015
Finalización del estudio (Actual)
1 de noviembre de 2015
Fechas de registro del estudio
Enviado por primera vez
23 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
1 de abril de 2015
Publicado por primera vez (Estimar)
7 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
4 de noviembre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PG.2015/3645
- Delibera 387/C 17 Marzo 2015 (Otro identificador: Azienda USL 07 Carbonia, Regione Sardegna)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .