Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy
- Conditions
- Digestive Illness
- Interventions
- Drug: Polyethylene Glycol 4000 with electrolytesDrug: PEG-3350 with electrolytes
- Registration Number
- NCT04153084
- Brief Summary
The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 126
- From 1 to 16 years old.
- Patients that signed the informed consent form.
- Urgent colonoscopy
- History of intestinal resection
- Nephropathy, heart disease or metabolic syndrome.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High volume electrolytes Polyethylene Glycol (PEG 4000) cohort 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 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 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.
- Primary Outcome Measures
Name Time Method Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale From November 2018 to December 2019 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.
- Secondary Outcome Measures
Name Time Method Evaluate the acceptance of the different preparations. From November 2018 to December 2019 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.
Evaluate the tolerance of the different preparations. From November 2018 to December 2019 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.
Evaluate the security of the different preparations. From November 2018 to December 2019 The security will be measured analysing the existence of adverse effects due to the different preparations.
Trial Locations
- Locations (8)
Complejo Hospitalario Torrecárdenas
🇪🇸Almería, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Cádiz, Spain
Hospital Materno-Infantil de Badajoz
🇪🇸Badajoz, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Instituto Hispalense de Pediatría
🇪🇸Sevilla, Spain