Digestive Illness
Conditions
Keywords
Pediatric colonoscopy, Endoscopic preparations, PEG, Sodium picosulfate, Bohm solution, Movicol, Picoprep, Colonoscopic examination
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.
Interventions
The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
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.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
Primary ContactAlejandro Rodríguez Martínez
Outcome results
None listed