Colonoscopy Preparation
Conditions
Brief summary
Children hospitalized at the Department of Pediatric Gastroenterology and Nutrition at the Medical University of Warsaw with suspected or confirmed inflammatory bowel disease (IBD) will be invited to participate in the study. Data regarding demographics, current body weight, height, and the number of daily bowel movements during the week prior to the colonoscopy will be collected for each patient. On the day before the colonoscopy, all patients will be placed on a low-residue diet until 3:00 PM. Children will be randomly assigned-based on a computer-generated randomization list-to one of two groups: * one group will receive a high-volume polyethylene glycol (PEG)-based preparation at a dose of 100 ml/kg of body weight (maximum 4 liters), * the other group will receive a low-volume preparation containing sodium picosulfate and magnesium oxide at the following doses: for patients ≤9 years of age, two doses of ½ sachet (150 ml total); for patients \>9 years of age, two doses of 1 sachet (300 ml total); along with an appropriate volume of fluids: a minimum of 1500 ml for patients ≤9 years of age and a minimum of 3000 ml for patients \>9 years of age. The children will receive the preparations after 3:00 PM on the day before the colonoscopy. In addition to the aforementioned fluid intake, the patient may consume any amount of clear fluids; the total volume of fluids consumed will be recorded in the patient's chart. Each patient will receive detailed written instructions outlining the individual dosage of the preparation and the colonoscopy preparation regimen. Additionally, a discussion will be held with the patient and their parent or guardian to review the preparation process and emphasize the importance of proper bowel cleansing for the quality of the examination. The quality of bowel preparation will be assessed using the Bristol Bowel Preparation Scale (BBPS) scale by the physician performing the colonoscopy. The patient and their parent or guardian will rate the tolerability of the colonoscopy preparation using a 10-point visual analogue scale. In all cases, a prerequisite for inclusion in the study will be obtaining written or verbal consent from the child's parents or guardians and from any child over the age of 16, as well as from a younger child if they are capable of understanding the purpose of the study.
Interventions
DRUGpolyethylene glycol (PEG 4000) (Forlax ®)
polyethylene glycol (PEG) at a dose of 100 ml/kg of body weight (maximum 4 liters)
DRUGCitrafleet®
Sodium picosulfate and magnesium oxide at the following doses: for patients aged ≤9 years, 2 × ½ sachet (total 150 ml); for patients aged \>9 years, 2 × 1 sachet (total 300 ml); plus an adequate amount of fluids: for patients aged ≤9 years, a minimum of 1500 ml; for patients aged \>9 years, a minimum of 3000 ml.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* suspected IBD or IBD diagnosed according to the widely accepted Porto criteria (incorporating clinical, endoscopic, and histopathological criteria); * eligibility for colonoscopy; * normal laboratory test results: sodium, potassium, and creatinine levels; * informed consent from the child's parents or guardians for participation in the study; for children over 16 years of age, additional consent from the child participating in the study.
Exclusion criteria
* following gastrointestinal surgery; * with renal failure or heart failure; * with conditions other than IBD that constitute an indication for colonoscopy; * whose parents or guardians have not consented to participation in the study; or, in the case of children over 16 years of age, lack of consent from the child.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation of the whole colon | in 10 minutes after colonoscopy | Overall bowel cleansing grade on the Boston Bowel Preparation Scale (BBPS); 0-9 points; the higher the score, the better the bowel cleansing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation for colon sections | in 10 minutes after colonoscopy | Boston bowel preparation score for: the right side of the colon the transverse section of the colon the left side of the colon assessed in the Boston Bowel Preparation Scale (BBPS); 0-9 points; the higher the score, the better the bowel cleansing. |
| Time between the last dose of cleansing and colonoscopy | in 10 minutes after colonoscopy | time from the last dose of laxative solution to the start of the colonoscopy (in minutes) |
| Tolerability | in the first 6 hours after colonoscopy | Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort |
| Acceptability | in the first 6 hours after colonoscopy | Patient's satisfaction of bowel preparation measured by 10-point visual-analogue scale (VAS,0 points indicates very poor tolerance, 10 points indicates very good tolerance) |
| First bowel movement | in 10 minutes before the start of colonoscopy | time from the start of taking the preparation to the first bowel movement (in minutes) |
Countries
Poland
Outcome results
None listed