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Clinical Trial Details

Trial ID: L1230
Source ID: NCT04709770
Associated Drug: 2-Liters Polyethylene Glycol With Citrate And Simethicone
Title: Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis
Acronym: PrepDial
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Colon Polyp|Dialysis; Complications|Colon Cancer
Interventions: DRUG: 2-liters polyethylene glycol with citrate and simethicone|DRUG: 4-liters polyethylene glycol with simethicone|DIETARY_SUPPLEMENT: Low-residue diet
Outcome Measures: Primary: Adequate bowel preparation, Proportion of participants with Boston Bowel Preparation Scale ≥6 with each segmental score ≥2, During colonoscopy | Secondary: Adenoma detection rate, Proportion of patients with at least one adenoma, During colonoscopy|Cecal intubation rate, Proportion of endoscopic examinations reaching the cecum, During colonoscopy|Participants' compliance, Proportion of participants with intake of at least 75 percent of the bowel preparation, During colonoscopy|Participants' tolerability, Proportion of participants presenting nausea, bloating, vomiting, abdominal pain, and/or anal irritation, During colonoscopy|Willingness to repeat the preparation, Proportion of participants willing to use the same bowel preparation for future examinations, During colonoscopy|Adverse events, Proportion of participants with any adverse event occurred during the intake of bowel preparation, During colonoscopy and the first hemodialysis session following colonoscopy|All-cause hospitalization, Proportion of participants hospitalized after bowel preparation intake for any cause, Within a 30-day period|All-cause mortality, Proportion of participants who died after bowel preparation intake for any cause, Within a 30-day period|Emergency hemodialysis sessions, Proportion of participants needing additional hemodialysis sessions, Within a 30-day period|Cardiovascular events, Proportion of participants with cardiovascular events (i.e. nonfatal myocardial infarction, acute coronary syndrome, and/or heart failure), Within a 30-day period|Interdialytic body weight gain, Mean increase in body weight from the hemodialysis session preceding the intake of bowel preparation to the one following the colonoscopy, During the hemodialysis session preceding and the one following the intake of bowel preparation|Variations in serum-electrolyte levels, Mean variation in serum-electrolyte levels between the hemodialysis session preceding and following the intake of bowel preparation, During the hemodialysis session preceding and the one following the intake of bowel preparation|Systolic blood pressure, Mean variation in systolic blood pressure between the hemodialysis session preceding and following the intake of bowel preparation, During the hemodialysis session preceding and the one following the intake of bowel preparation|Diastolic blood pressure, Mean variation in diastolic blood pressure between the hemodialysis session preceding and following the intake of bowel preparation, During the hemodialysis session preceding and the one following the intake of bowel preparation|Blood flow on dialysis, Mean variation in blood flow on dialysis between the hemodialysis session preceding and following the intake of bowel preparation, During the hemodialysis session preceding and the one following the intake of bowel preparation
Sponsor/Collaborators: Sponsor: Alfredo Di Leo | Collaborators: Alfasigma S.p.A.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 264
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-02-01
Completion Date: 2022-03-01
Results First Posted:
Last Update Posted: 2021-01-14
Locations:
URL: https://clinicaltrials.gov/show/NCT04709770