Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy
| Registry | NCT04153084 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 126 (Estimated) |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other) |
| Conditions | Digestive Illness |
| Interventions | Polyethylene Glycol 4000 with electrolytes, PEG-3350 with electrolytes, Sodium picosulfate (Drug) |
| Dates | start 2018-10-01, primary completion 2019-12-15 (estimated), completion 2019-12-31 (estimated), first posted 2019-11-06, last updated 2019-11-08 |
| Locations | 8 sites in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Digestive Illness All trials of Polyethylene Glycol 4000 with electrolytes All trials of PEG-3350 with electrolytes
The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| High volume electrolytes Polyethylene Glycol (PEG 4000) cohort | Drug: Polyethylene Glycol 4000 with electrolytes | 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. | |
| Low volume electrolytes PEG (PEG 3350) cohort | Drug: PEG-3350 with electrolytes | 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. | |
| Sodium picosulfate cohort | Drug: Sodium picosulfate | 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. |
Sex: All, ages: 1 Year to 16 Years
Inclusion Criteria: * From 1 to 16 years old. * Patients that signed the informed consent form. Exclusion Criteria: * Urgent colonoscopy * History of intestinal resection * Nephropathy, heart disease or metabolic syndrome.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitario Puerta del Mar | Cadiz, Cádiz | Spain | Not yet recruiting |
| Complejo Hospitalario Torrecárdenas | Almería | Spain | Not yet recruiting |
| Hospital Materno-Infantil de Badajoz | Badajoz | Spain | Not yet recruiting |
| Hospital Universitario Reina Sofía | Córdoba | Spain | Not yet recruiting |
| Hospital Universitario Virgen de las Nieves | Granada | Spain | Not yet recruiting |
| Hospital Universitario Virgen Macarena | Seville | Spain | Recruiting |
| Hospital Universitario Virgen del Rocío | Seville | Spain | Recruiting |
| Instituto Hispalense de Pediatría | Seville | Spain | Not yet recruiting |