Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis (PrepDial)
Chronic Kidney Diseases, Colon Polyp, Dialysis; Complications
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Colonoscopy, Bowel cleansing, Adenoma detection, Polyethylene glycol, Hemodialysis
Eligibility Criteria
Inclusion Criteria:
- prevalent end stage kidney disease on hemodialysis people (on hemodialysis for ≥6 months; either hemodialysis or hemofiltration or hemodiafiltration, received for at least 3 times/week for a minimum duration of 4 hours per treatment session for a minimum of 12 hours/week, according to standard practice for quality hemodialysis in Italy);
- inpatients and outpatients with an indication to colonoscopy (e.g. positive fecal occult blood test or fecal immunochemical test, signs or symptoms of colorectal disease, colorectal cancer screening, colorectal cancer surveillance, inflammatory bowel diseases, or inclusion in kidney transplantation waiting list);
- signature of written informed consent.
Exclusion Criteria:
- end stage kidney disease not on hemodialysis (eg. peritoneal dialysis or kidney transplantation);
- previous kidney transplantation;
- need for colonoscopy in emergency;
- previous colorectal surgery;
- contraindications to colonoscopy in the opinion of the managing physician;
- pregnancy or breastfeeding assessed by dedicated pregnancy tests;
- known or suspected hypersensitivity to any components of preparations.
- gastrointestinal perforation;
- toxic megacolon;
- inflammatory bowel disease (such as rectal ulcerative colitis, Crohn's disease) in severe acute phase;
- occlusive, sub-occlusive or stenotic forms of the intestine, gastric stasis, dynamic ileus, paralytic ileus;
- severe state of dehydration;
- phenylketonuria (due to the presence of aspartame);
- glucose-6-phosphate dehydrogenase deficiency;
- severe heart failure: New York Heart Association (NYHA) class III-IV;
- significant alterations of electrolytes, according to the physician's judgment;
- participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives before the study drug.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Low-volume preparation
High-volume preparation
Low-volume preparation of 2-liters polyethylene glycol with citrate and simethicone. This formulation includes 4 large (A) and 4 small (B) sachets; the components of 2 sachets A and 2 sachets B are mixed in 1 liter of water. Each sachet A contains: polyethylene glycol (4000) 52.50 g; simethicone 0.08 g; sodium sulphate anhydrous 3.75 g. Each sachet B contains: sodium citrate 1.863 g; anhydrous citric acid 0.813 g; sodium chloride 0.73 g; potassium chloride: 0.37 g; acesulfame potassium 0.13 g. Participants will drink the first liter of preparation at 19.00 p.m. on the day before the colonoscopy, at a rate of 250 ml every 15 minutes, followed by 500 ml of clear liquids. The second liter of preparation will be administered at 7.00 a.m. on the day of the colonoscopy, at a rate of 250 ml every 15 minutes, followed by 500 ml of clear liquids.
High-volume preparation with 4-liters polyethyleneglycol with simethicone. This formulation includes 4 sachets, each dissolved in 1 liter of water. Each sachet contains: polyethylene glycol (4000) 58.30 g; simethicone 0.08 g; sodium sulphate anhydrous 5.68 g; sodium bicarbonate 1.68 g; sodium chloride 1.46 g; potassium chloride 0.74 g. Participants will drink the first 2 liters of preparation at 19.00 p.m. on the day before colonoscopy, at a rate of 250 ml every 15 minutes. The remaining 2 liters of preparation will be administered at 6.00 a.m. on the day of the endoscopic procedure, at a rate of 250 ml every 15 minutes.