Elective Colonoscopy
Conditions
Keywords
Colonoscopy preparation, Bowel cleansing, Mannitol
Brief summary
This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
Detailed description
Not provided
Interventions
DRUG100g of Mannitol
Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water
DRUG1L PEG-Asc
Self administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour.
Sponsors
NTC srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized 1:1, parallel-group, endoscopist-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability of subject to consent and provide signed written informed consent. 2. Age ≥ 18 years. 3. Males and females scheduled for elective colonoscopy performed according to ESGE guidelines. 4. Subjects willing and able to complete the entire study and to comply with instructions.
Exclusion criteria
1. Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2\* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy). 2. Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed. 3. Severe renal failure: eGFR \< 30 ml/min/1.73 m2 estimated by simplified MDRD equation. 4. Severe heart failure: New York Heart Association (NYHA) Class III-IV. 5. Severe anaemia (Hb ≤ 8 g/dl). 6. Chronic liver disease Child-Pugh class B or C. 7. Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges). 8. Clinically significant alterations of baseline haemato-chemical parameters. 9. Recent (\< 6 months) symptomatic acute ischemic heart disease. 10. History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann's procedure and other surgeries involving the structure and function of the colon. 11. History of paralysis of the gut (ileus). 12. History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.). 13. History of phenylketonuria (due to presence of aspartame). 14. History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate). 15. History of toxic megacolon. 16. Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy. 17. Suspected bowel obstruction or perforation. 18. Indication for partial colonoscopy. 19. Subjects who received an investigational drug or therapy within 5 half-lives of the first visit. 20. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs. 21. Underwater colonoscopy instead of standard gas insufflation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) | Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) | Adenoma detection rate, defined as the proportion of subjects ≥ 50 years old undergoing colonoscopy who have at least one lesion detected. |
| Caecal intubation rate | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) | Caecal intubation rate, defined as the proportion of subjects undergoing colonoscopy with ileocecal junction appendiceal orifice visible to the endoscopist. |
| Proportion of subjects undergoing colonoscopy who have to repeat the procedure | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) | Proportion of subjects undergoing colonoscopy who have to repeat the procedure due to inadequate intestinal cleansing to resolve, at the discretion of the endoscopist, the clinical issue underlying the request for colonoscopy. |
| Proportion of subjects undergoing colonoscopy with presence of colonic bubbles | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) | Proportion of subjects undergoing colonoscopy with presence of colonic bubbles assessed through the Colon Endoscopic Bubble Scale (CEBuS). |
Countries
Belgium, Italy, Poland, Spain, Sweden
Contacts
CONTACTAlessandro Colombo
STUDY_CHAIRCristiano Spada, Prof.
Policlinico Universitario A. Gemelli
Outcome results
None listed