Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 glycol-based preparation) or low-volume (2-liter polyethylene glycol-based solutions or sodium picosulphate plus magnesium citrate) formulations for routine bowel preparation.

Some concerns have been raised about the use of oral bowel-cleansing agents in people receiving hemodialysis due to the possibility of secondary intravascular depletion. There is a risk for thrombosis of dialysis access in case of hypotension. The association of hemodialysis treatment and the use of bowel preparations may induce severe hypovolaemia. Finally, the 4-liter intake with high-volume preparations may cause fluid overload in anuric patients.

The aim of our study will be to assess in a randomized trial the non-inferiority of a low-volume versus a high-volume polyethylene glycol-based bowel preparation for adequate bowel cleansing in people receiving hemodialysis (primary end-point). We will also compare the low-volume versus the high-volume preparation for other endoscopic and nephrologic relevant clinical outcomes (secondary end-points).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alfredo Di Leo
• Collaborator: Alfasigma S.p.A.
• Treatments: Simethicone

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.