Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy
NCT ID: NCT04153084
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
126 participants
OBSERVATIONAL
2018-10-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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High volume electrolytes Polyethylene Glycol (PEG 4000) cohort
Pediatric patients who have prepared for a colonoscopy during the years 2018-2019 using high volume electrolytes PEG (Bohm solution®) endoscopic preparation, as part of a diagnostic procedure not related to this study.
Polyethylene Glycol 4000 with electrolytes
The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
Low volume electrolytes PEG (PEG 3350) cohort
Pediatric patients who have prepared for a colonoscopy during the years 2018-2019 using low volume electrolytes PEG (Movicol®) endoscopic preparation, as part of a diagnostic procedure not related to this study.
PEG-3350 with electrolytes
The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
Sodium picosulfate cohort
Pediatric patients who have prepared for a colonoscopy during the years 2018-2019 using sodium picosulfate (Picoprep®) endoscopic preparation, as part of a diagnostic procedure not related to this study.
Sodium picosulfate
The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age:
* From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h)
* From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
* From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
* Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night.
Interventions
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Polyethylene Glycol 4000 with electrolytes
The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
PEG-3350 with electrolytes
The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
Sodium picosulfate
The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age:
* From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h)
* From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
* From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
* Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients that signed the informed consent form.
Exclusion Criteria
* History of intestinal resection
* Nephropathy, heart disease or metabolic syndrome.
1 Year
16 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Alejandro Rodríguez Martínez
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Rocío
Locations
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Hospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain
Complejo Hospitalario Torrecárdenas
Almería, , Spain
Hospital Materno-Infantil de Badajoz
Badajoz, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Instituto Hispalense de Pediatría
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Cristina Pérez Aragón
Role: primary
Rafael Galera Martínez
Role: primary
Ana María Márquez Armenteros
Role: primary
Rafael González de Caldas Marchal
Role: primary
María Medina Gil
Role: primary
Carmen Cuadrado Caballero
Role: primary
Alejandro Rodríguez Martínez
Role: primary
Joaquín Reyes Andrade
Role: primary
Other Identifiers
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FIS-POL-2017-01
Identifier Type: -
Identifier Source: org_study_id
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