A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy

A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens

Patrocinadores

Patrocinador principal: Clinical Hospital Colentina

Fuente Clinical Hospital Colentina
Resumen breve

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.

Estado general Completed
Fecha de inicio February 2014
Fecha de Terminación December 2015
Fecha de finalización primaria September 2015
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
bowel cleansing 24 hours
Resultado secundario
Medida Periodo de tiempo
patient comfort level during bowel cleansing 24 hours
Inscripción 185
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Standard approach

Descripción: bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate

Etiqueta de grupo de brazo: Standard approach

Tipo de intervención: Drug

Nombre de intervención: Individualized approach

Etiqueta de grupo de brazo: Individualized approach

Otro nombre: 4 L polyethylene glycol or sodium picosulphate / magnesium citrate

Elegibilidad

Criterios:

Inclusion Criteria:

- all patients > 18 years of age undergoing elective colonoscopy on an outpatient basis

Exclusion Criteria:

- refusal to sign informed consent

- pregnancy

- advance kidney, liver or heart disease

- suspicion of malignant / benign stenosis of the digestive tract

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Theodor Voiosu, MD, PhD Principal Investigator Clinical Hospital Colentina
Ubicación
Instalaciones:
Colentina Clinical Hospital | Bucharest, 020125, Romania
Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor | Cluj, Romania
Spitalul CFR | Cluj, Romania
Ubicacion Paises

Romania

Fecha de verificación

January 2016

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Clinical Hospital Colentina

Nombre completo del investigador: dr. Theodor Alexandru Voiosu

Título del investigador: MD, gastroenterology resident

Palabras clave
Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: Standard approach

Tipo: Active Comparator

Descripción: patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic: 4L split polyethylene glycol solution split magnesium citrate/sodium picosulphate preparation regimen

Etiqueta: Individualized approach

Tipo: Experimental

Descripción: patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level)

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Enmascaramiento: Single (Outcomes Assessor)

Fuente: ClinicalTrials.gov