Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy

Conditions
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Digestive Illness

Intervention / Treatment
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* Drug: Polyethylene Glycol 4000 with electrolytes
* Drug: PEG-3350 with electrolytes
* Drug: Sodium picosulfate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High volume electrolytes Polyethylene Glycol (PEG 4000) cohort<br>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. | Drug: Polyethylene Glycol 4000 with electrolytes<br>* The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.<br>* Other names: Bohm solution®;|
| Low volume electrolytes PEG (PEG 3350) cohort<br>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. | Drug: PEG-3350 with electrolytes<br>* The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.<br>* Other names: Movicol®;|
| Sodium picosulfate cohort<br>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. | Drug: Sodium picosulfate<br>* 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.<br>* Other names: Picoprep®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG, Pediatric colonoscopy, Endoscopic preparations, Sodium picosulfate, Bohm solution, Movicol, Picoprep, Colonoscopic examination