A Phase 4 interventional study of 2-liters polyethylene glycol with citrate and simethicone and 4-liters polyethylene glycol with simethicone in Chronic Kidney Diseases, Colon Polyp and Dialysis; Complications, sponsored by Alfredo Di Leo. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-14.
Sponsored by Alfredo Di Leo · Phase 4, Interventional, and Treatment
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).
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.
Consecutive inpatients and outpatients on hemodialysis with an indication to undergo colonoscopy (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) will be screened for inclusion in the trial.
At enrolment visit, eligible subjects will be allocated to either the low-volume or high-volume bowel preparation group (ratio 1:1). Participants in the low-volume group will receive the formulation of 2-liters polyethylene glycol with citrate and simethicone (Clensia, Alfasigma S.p.A., Milan, Italy), while those in the high-volume arm will receive 4-liters polyethylene glycol with simethicone (Selg Esse, Alfasigma S.p.A., Milan, Italy). Participants in both groups will be prescribed a low residue diet for 3 days before colonoscopy and will be instructed to take the bowel cleansing agents as split dose, taking the first half of solution the evening before the endoscopic examination and the second in the morning of the day of the procedure. To improve compliance, participants will also receive a booklet in plain language to explain the details of low residue diet and modality of bowel preparation intake.
All endoscopic examinations will be scheduled on days free from dialysis sessions between 2 and 5 hours after the end of the administration of the last dose of preparation. On the day of the colonoscopy, all participants will fill in a questionnaire to measure participants' compliance, tolerability, and willingness to repeat the preparation they have been allocated to. Participants will be aware of the bowel preparation they received. On the opposite, endoscopists and nephrologists measuring primary and secondary outcomes (i.e. outcome assessors) will be blinded to the arm each subject has been allocated to and instructed to avoid any discussion with participants that could reveal the type of bowel cleansing agent.
Recruitment will last 12 months and follow-up will be completed 1 month after the last participant undergoes colonoscopy.
Before randomization and during the one-month follow-up, participants will receive (in a non-randomized fashion) all relevant co-interventions (e.g. iron, lipid-lowering agents, bone disease agents, antihypertensive agents, etc.), which are peculiar of standard hemodialysis treatment, as per their usual attending physician's practice to achieve and maintain standard hemodialysis clinical performance measures.
At the time of enrolment and colonoscopy scheduled simple trial follow-up visits will be performed. All clinical events following the endoscopic procedure will be measured during the one-month follow-up period.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's planned enrollment of 264 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
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Exclusion Criteria:
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.
Drug: 2-liters polyethylene glycol with citrate and simethicone · Dietary Supplement: Low-residue diet
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.
Drug: 4-liters polyethylene glycol with simethicone · Dietary Supplement: Low-residue diet
Low-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Also known as: Clensia
High-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Also known as: Selg Esse
Diet before colonoscopy.
Adequate bowel preparation
Proportion of participants with Boston Bowel Preparation Scale ≥6 with each segmental score ≥2
Time frame: During colonoscopy
Adenoma detection rate
Proportion of patients with at least one adenoma
Time frame: During colonoscopy
Cecal intubation rate
Proportion of endoscopic examinations reaching the cecum
Time frame: During colonoscopy
Participants' compliance
Proportion of participants with intake of at least 75 percent of the bowel preparation
Time frame: During colonoscopy
Participants' tolerability
Proportion of participants presenting nausea, bloating, vomiting, abdominal pain, and/or anal irritation
Time frame: During colonoscopy
Willingness to repeat the preparation
Proportion of participants willing to use the same bowel preparation for future examinations
Time frame: During colonoscopy
Adverse events
Proportion of participants with any adverse event occurred during the intake of bowel preparation
Time frame: During colonoscopy and the first hemodialysis session following colonoscopy
All-cause hospitalization
Proportion of participants hospitalized after bowel preparation intake for any cause
Time frame: Within a 30-day period
All-cause mortality
Proportion of participants who died after bowel preparation intake for any cause
Time frame: Within a 30-day period
Emergency hemodialysis sessions
Proportion of participants needing additional hemodialysis sessions
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
No study locations are listed for this record.
Plan to share: No
Start is estimated for Feb 2021; primary completion for Mar 2022, 13 months later.
Of 102 non-industry phase 4 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 62. This study's planned 13 months is below that.
Counting every sponsor, half of 120 studies reached it within 37 months; a quarter within 24 and three quarters within 62.
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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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