Status:
UNKNOWN
Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis
Lead Sponsor:
Alfredo Di Leo
Collaborating Sponsors:
Alfasigma S.p.A.
Conditions:
Chronic Kidney Diseases
Colon Polyp
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Current American Society for Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend a split regimen of high-volume (4-liter polyethylene glyco...
Detailed Description
Study design: This will be a multicentre, outcome assessor-blinded, parallel-arm, centrally randomized, non-inferiority trial. Randomization will be performed centrally by the coordinating center. C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT04709770
Start Date
February 1 2021
End Date
March 1 2022
Last Update
January 14 2021
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