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The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol 4000 with electrolytes | Drug | The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale | The quality of the preparations will be measured using the Boston Bowel Preparation Scale (BBPS), semiquantitative evaluation of the cleanliness of the three colon sections (left, transverse, right) using a score from 0 to 3, giving a total score of 0 (without preparation) to 9 (optimal) and it´s done by two independent observers. | From November 2018 to December 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the acceptance of the different preparations. | The acceptance will be measured using a questionnaire and a quantity record, the questonnaire is made by three items: flavour, odour and volume while the quantity record measures the quantity of preparation ingested by the participant. | From November 2018 to December 2019 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients who have undergone a colonoscopic exploration during the years 2018-2019, as part of a diagnostic process not related to the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Rodríguez Martínez | Contact | 955012000 | alejandro.rodriguez.m.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Rodríguez Martínez | Hospital Universitario Virgen Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta del Mar | Not yet recruiting | Cadiz | Cádiz | 41019 | Spain |
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| PEG-3350 with electrolytes | Drug | The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours. |
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| Sodium picosulfate | Drug | The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age:
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| Evaluate the tolerance of the different preparations. |
The tolerance will be measured using a questionnaire and a symptoms record, with a score from 0 (terrible tolerance) to 3 (good tolerance) for each of its items, that are the following: abdominal pain, nausea and vomit, intestinal noises, abdominal distension, burps, flatulences, urgent bowel movements and tenesmus. |
| From November 2018 to December 2019 |
| Evaluate the security of the different preparations. | The security will be measured analysing the existence of adverse effects due to the different preparations. | From November 2018 to December 2019 |
| Complejo Hospitalario Torrecárdenas | Not yet recruiting | Almería | 04009 | Spain |
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| Hospital Materno-Infantil de Badajoz | Not yet recruiting | Badajoz | 06010 | Spain |
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| Hospital Universitario Reina Sofía | Not yet recruiting | Córdoba | 14004 | Spain |
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| Hospital Universitario Virgen de las Nieves | Not yet recruiting | Granada | 18014 | Spain |
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| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| Instituto Hispalense de Pediatría | Not yet recruiting | Seville | 41013 | Spain |
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| ID | Term |
|---|---|
| C000595214 | polyethylene glycol 4000 |
| D004573 | Electrolytes |
| C000595212 | polyethylene glycol 3350 |
| C005701 | picosulfate sodium |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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