The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to colonoscopy. The patients to be examined are all referred to exclude colorectal cancer disease. The cleansing process is not directly related to treatment of these patients but have an effect on the visualisation of the mucosa of the bowel and thus the quality of the colonoscopy. MedDRA version: 27.0 Level: LLT Classification code 10061839 Term: Endoscopy large bowel System Organ Class: 1
Conditions
Interventions
Trade Name: Plenvu
Product Name: Plenvu
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: Macrogol 3350
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
C
Sponsors
Region Nordjylland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Ambulant colonoscopy 2-Older than18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1-Younger than 18. 2-Known with severe heart failure 3-Known with severe renal failure (eGFR<30) 4-Known with colonic stenosis 5-Pregnant or breastfeeding 6-Acute colonoscopy 7-Cancer screening program colonoscopy 8-Mentally retarded 9-Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation. 10-Patients with Phenylketonuria 11-Patients with Glucose-6-phosphate-dehydrogenase deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study is to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu® with the well established bowel preparation Picoprep® as cleansing agents before colonoscopy. This is to test whether the low volume Polyethylin Glycol-electrolytes lavage solution preparation Plenvu® would have non-inferior efficacy on bowel preparation compared with Picosulfate based Picoprep® with a better effect on compliance and tolerability.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the efficacy of cleansing preparations measured by the quality of cleansing. This is done using the validated Harfield Cleansing Scale. The cleansing quality is measured after dividing the colon into 5 segments (Rectum, sigmoid colon, Descending colon, Transverse colon, and Ascending colon/Cecum) and each segment is scored from 0 (irremovable heavy hard stool) to 4 (empty and clean), then a total grade is given. Grade A (all segments scored 3 or 4) and B (one or more segments scored 2) are considered as successful cleansing. Grade C (one or more segments scored 1) and D (one or more segments scored 0) is considered unsuccessful cleansing8.;Timepoint(s) of evaluation of this end point: Both endpoints can be evaluated at the same day of the colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is the tolerability of the patient to cleansing preparation. A previously validated tolerability questionnaire9 is used to measure this with the addition of a single question regarding the total amount of fluid the patient could drink as a percentage of the total required fluid and the visual assisted score testing the general tolerability is changed to a numeric score from 0 to 10. The questionnaire is translated from English to Danish and then retranslated from Danish to English by a non-healthcare- related person then the English versions were compared to ensure validation of the Danish version.;Timepoint(s) of evaluation of this end point: Both endpoints can be evaluated at the same day of the colonoscopy. | — |
Countries
Denmark
Contacts
Public ContactHayder Alqaisi
Regionshospital Nordjylland
Outcome results
None listed