A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
Colon Disease
About this trial
This is an interventional treatment trial for Colon Disease focused on measuring colonoscopy, bowel cleansing
Eligibility Criteria
Inclusion Criteria:
- Ambulant colonoscopy
- Older than18
Exclusion Criteria:
- Younger than 18
- Known with severe heart failure
- Known with severe renal failure (eGFR<30)
- Known with colonic stenosis
- Pregnant or breastfeeding
- Acute colonoscopy
- Cancer screening program colonoscopy
- Mentally retarded
- Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
- Patients with Phenylketonuria
- Patients with Glucose-6-phosphate-dehydrogenase deficiency
Sites / Locations
- Fredercikshavn hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Picoprep
Plenvu
Picoprep®: Active substances: An envelope Picoprep® contains 10 mg sodium picosulfate, 3,5 g magnesium oxide, and 12 g citric acid. Mechanism of action: Sodium picosulfate is a peristaltic agent that increases the peristalsis of the intestine. Magnesium oxide and citric acid are osmotic agents to increase water content in the bowel. Dosage and administration: consist of 2 envelopes, the first envelope, after dissolving in 150 ml water, should be taken 10-18 hours before the colonoscopy, then at least 250mlX5 clear fluid (not only water) over the next hours before the second dose is taken. The second envelope should be taken 4-6 hours before colonoscopy followed by 250mlX3 clear fluid (not only water) over the next hours before colonoscopy. The total fluid intake is approximately 2.3 L.
Plenvu®: Active substances: Dose nr. 1 1 envelope contains 1 g potassium chloride, 100 g macrogol 3350, 2 g sodium chloride, and 9 g sodium sulfate. Dose nr. 2 1 envelope A contains 1,2 g potassium chloride, 40 g macrogol 3350, and 3,2 g sodium chloride. 1 envelope B contains 7,54 g ascorbic acid (Vit. C) and 48,11 g sodium ascorbate. Mechanism of action: Macrogol 3350 is an osmotic laxative. The added electrolytes are to prevent electrolyte shifting and systemic disturbances. Dosage and administration: two separate nonidentical 500 ml doses are given. 2-day regime: dose nr.1 envelope is dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock evening before colonoscopy day. Dose nr.2 envelope A and B are dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock on the morning of colonoscopy day. After each dose of the dissolved Plenvu®, the patient should drink at least 500ml clear fluid.