Bowel preparation before colonoscopy MedDRA version: 20.0 Level: HLGT Classification code 10017971 Term: Gastrointestinal investigations System Organ Class: 10022891 - Investigations MedDRA version: 21.1 Level: PT Classification code 10066943 Term: Bowel preparation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Moviprep
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Macrogol 3350
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
Concentration type: equal
Conc
Sponsors
Morten Rasmussen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants in the Danish national bowel cancer screening scheduled for colonoscopy at one of the two centres (Bispebjerg Hospital or Herlev Hospital 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 637 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 637
Exclusion criteria
Exclusion criteria: • Not able to understand, read or speak Danish • Not able to receive documents sent via e-Boks • Anticipated compliance problems • Hypersensitivity to the active substances in Moviprep or Plenvu • Gastrointestinal obstruction or perforation • Disorders of gastric emptying • Ileus • Phenylketonuria • Glucose-6-phosphate dehydrogenase deficiency • Toxic megacolon • Severe chronic inflammatory bowel disease • Pregnancy • Breastfeeding • Severe kidney impairment (creatinine clearance less than 30 ml/minute/1.73 m2 • Cardiac failure (grade III or IV of NYHA) • Those at risk of arrhythmias • Dehydration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the bowel cleansing efficacy of either Plenvu or PEG with ascorbate in a randomized controlled trial including persons participating in the Danish national bowel screening program.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint will be efficacy of the bowel preparation. Efficacy will be assessed as bowel cleansing success according to the validated Boston Bowel Preparation Scale (BBPS). Bowel preparation quality will be assessed by the colonoscopist for the following colonic segments: Right colon (cecum and ascending colon), transverse colon (hepatic flexure, transverse colon and splenic flexure), left colon (descending colon, sigmoid colon and rectum). After washing and suctioning have been performed each segment is given a score from 0-3 based on following definition: 0: Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1: Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2: Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3: Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. Adequate bowel preparation will be defined as a score of at least 2 according to the BBPS for each colonic segment. ;Timepoint(s) of evaluation of this end point: Quality of bowel preparation will be assessed during the colonoscopy by the endoscopist. Data will be recorded immediately after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be polyp detection rate, overall polyp detection, ADR, overall/mean adenoma detection, cancer detection rate, cecal intubation rate, detection of serrated lesions and completion rate. Tolerability of the bowel preparation. Tolerability will be assessed immediately prior to colonoscopy. Following parameters will be addressed: Vomiting, nausea, bloating, headache, quality of sleep, willingness to repeat preparation. Ability to drink all preparation and to drink supplementary clear fluids. If no, how much preparation/supplementary fluids have been consumed (0-24%, 25-49%, 50-74%, 75-99%). Time to first stool and time gap between ingestion of last bowel preparation dose and colonoscopy will be noted. Incomplete colonoscopies will be stratified by following parameters: pain, stenosis, unpassable turn, complication, other.;Timepoint(s) of evaluation of this end point: Parameters concerning the colonoscopy (polyp detection, cecal intubation rate, completion rate,) will be assessed during the procedure by the endoscopist. Data will be recorded immediately after the procedure. Adenoma and cancer data will be based on histopathologic examination. Results will be recorded at a maximum of 30 days post procedure by look-up in medical file. Data on consumption of bowel preparation, additional fluids and passage of stool will be assessed by a questionnaire filled out prior to the colonoscopy. | — |
Countries
Denmark
Contacts
Public ContactMorten Rasmussen
Morten Rasmussen
Outcome results
None listed