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

NCT04709770 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2021-01-14

No results posted yet for this study

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).

Conditions

  • Chronic Kidney Diseases
  • Colon Polyp
  • Dialysis; Complications
  • Colon Cancer

Interventions

DRUG

2-liters polyethylene glycol with citrate and simethicone

Low-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.

DRUG

4-liters polyethylene glycol with simethicone

High-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.

DIETARY_SUPPLEMENT

Low-residue diet

Diet before colonoscopy.

Sponsors & Collaborators

  • Alfasigma S.p.A.

    collaborator INDUSTRY

  • Alfredo Di Leo

    lead OTHER

Principal Investigators

  • Alfredo Di Leo, MD PhD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-03-01
Completion
2022-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709770 on ClinicalTrials.gov