Chronic Kidney DiseasesPhase 4PrepDialNCT04709770
Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis
A Phase 4 study testing 2-liters polyethylene glycol with citrate and simethicone, 4-liters polyethylene glycol with simethicone and Low-residue diet in people with Chronic Kidney Diseases and Colon Polyp, run by Alfredo Di Leo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Colon Polyp, Dialysis; Complications
- What is being tested?
- 2-liters polyethylene glycol with citrate and simethicone, 4-liters polyethylene glycol with simethicone and Low-residue diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Low-volume Versus High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis: a Randomized Non-inferiority Trial
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).
Read the 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.
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.
- Being tested
- 2-liters polyethylene glycol with citrate and simethicone, 4-liters polyethylene glycol with simethicone, Low-residue diet
- Keywords
- Colonoscopy, Bowel cleansing, Adenoma detection, Polyethylene glycol, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-liters polyethylene glycol with citrate and simethiconeDrug
Also called Clensia
Low-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
4-liters polyethylene glycol with simethiconeDrug
Also called Selg Esse
High-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Low-residue dietDietary supplement
Diet before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Low-volume preparation | Experimental | 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. Receives: Drug: 2-liters polyethylene glycol with citrate and simethicone; Dietary Supplement: Low-residue diet |
| High-volume preparation | Active comparator | 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. Receives: Drug: 4-liters polyethylene glycol with simethicone; Dietary Supplement: Low-residue diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation
Proportion of participants with Boston Bowel Preparation Scale ≥6 with each segmental score ≥2
Measured: During colonoscopy
Secondary outcomes (15)
Adenoma detection rate
Proportion of patients with at least one adenoma
Measured: During colonoscopy
Cecal intubation rate
Proportion of endoscopic examinations reaching the cecum
Measured: During colonoscopy
Participants' compliance
Proportion of participants with intake of at least 75 percent of the bowel preparation
Measured: During colonoscopy
Participants' tolerability
Proportion of participants presenting nausea, bloating, vomiting, abdominal pain, and/or anal irritation
Measured: During colonoscopy
Willingness to repeat the preparation
Proportion of participants willing to use the same bowel preparation for future examinations
Measured: During colonoscopy
Adverse events
Proportion of participants with any adverse event occurred during the intake of bowel preparation
Measured: During colonoscopy and the first hemodialysis session following colonoscopy
All-cause hospitalization
Proportion of participants hospitalized after bowel preparation intake for any cause
Measured: Within a 30-day period
All-cause mortality
Proportion of participants who died after bowel preparation intake for any cause
Measured: Within a 30-day period
Emergency hemodialysis sessions
Proportion of participants needing additional hemodialysis sessions
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During the hemodialysis session preceding and the one following the intake of bowel preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfredo Di Leo
- Sponsor type
- University, hospital or other
- Collaborators
- Alfasigma S.p.A.
- Responsible party
- Sponsor-investigator, Alfredo Di Leo, University of Bari
- Investigators
- Alfredo Di Leo, MD PhD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709770
- Sponsor's protocol ID
- Policlinic Hospital 7
- Acronym
- PrepDial
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018 Jun 1;96(6):414-422D. doi: 10.2471/BLT.17.206441. Epub 2018 Apr 20.
PubMed 29904224de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
PubMed 19861670Komaki Y, Komaki F, Micic D, Ido A, Sakuraba A. Risk of Colorectal Cancer in Chronic Kidney Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2018 Oct;52(9):796-804. doi: 10.1097/MCG.0000000000000880.
PubMed 28723862Williams AW, Dwyer AC, Eddy AA, Fink JC, Jaber BL, Linas SL, Michael B, O'Hare AM, Schaefer HM, Shaffer RN, Trachtman H, Weiner DE, Falk AR; American Society of Nephrology Quality, and Patient Safety Task Force. Critical and honest conversations: the evidence behind the "Choosing Wisely" campaign recommendations by the American Society of Nephrology. Clin J Am Soc Nephrol. 2012 Oct;7(10):1664-72. doi: 10.2215/CJN.04970512. Epub 2012 Sep 13.
PubMed 22977214Abramowicz D, Cochat P, Claas FH, Heemann U, Pascual J, Dudley C, Harden P, Hourmant M, Maggiore U, Salvadori M, Spasovski G, Squifflet JP, Steiger J, Torres A, Viklicky O, Zeier M, Vanholder R, Van Biesen W, Nagler E. European Renal Best Practice Guideline on kidney donor and recipient evaluation and perioperative care. Nephrol Dial Transplant. 2015 Nov;30(11):1790-7. doi: 10.1093/ndt/gfu216. Epub 2014 Jul 9.
PubMed 25007790Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
PubMed 12838225Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
PubMed 15758907Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
PubMed 12135020ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.
PubMed 25595062Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
PubMed 25239068Connor A, Tolan D, Hughes S, Carr N, Tomson C. Consensus guidelines for the safe prescription and administration of oral bowel-cleansing agents. Gut. 2012 Nov;61(11):1525-32. doi: 10.1136/gutjnl-2011-300861. Epub 2012 Jul 26.
PubMed 22842619Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PubMed 19136102Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):819-826. doi: 10.1097/MEG.0000000000001175.
PubMed 29847488Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
PubMed 22239959
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-volume Versus High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis: a Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04709770
- Acronym / sponsor ID
- PrepDial / Policlinic Hospital 7
- Keywords
- Colonoscopy, Bowel cleansing, Adenoma detection, Polyethylene glycol, Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Alfredo Di LeoUniversity, hospital or other
- Collaborators
- Alfasigma S.p.A.
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-volume preparation | Experimental | Drug: 2-liters polyethylene glycol with citrate and simethicone, Dietary Supplement: Low-residue dietLow-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. |
| High-volume preparation | Active comparator | Drug: 4-liters polyethylene glycol with simethicone, Dietary Supplement: Low-residue dietHigh-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-liters polyethylene glycol with citrate and simethiconeAlso: ClensiaLow-volume polyethylene glycol-based bowel cleansing agent for colonoscopy. | Drug | Low-volume preparation |
| 4-liters polyethylene glycol with simethiconeAlso: Selg EsseHigh-volume polyethylene glycol-based bowel cleansing agent for colonoscopy. | Drug | High-volume preparation |
| Low-residue dietDiet before colonoscopy. | Dietary supplement | High-volume preparation, Low-volume preparation |
Primary outcome
Adequate bowel preparation
Time frame: During colonoscopy
Proportion of participants with Boston Bowel Preparation Scale ≥6 with each segmental score ≥2
15 secondary outcomes
Adenoma detection rate
Time frame: During colonoscopy
Cecal intubation rate
Time frame: During colonoscopy
Participants' compliance
Time frame: During colonoscopy
Participants' tolerability
Time frame: During colonoscopy
Willingness to repeat the preparation
Time frame: During colonoscopy
Adverse events
Time frame: During colonoscopy and the first hemodialysis session following colonoscopy
All-cause hospitalization
Time frame: Within a 30-day period
All-cause mortality
Time frame: Within a 30-day period
Emergency hemodialysis sessions
Time frame: Within a 30-day period
Cardiovascular events
Time frame: Within a 30-day period
Interdialytic body weight gain
Time frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
Variations in serum-electrolyte levels
Time frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
Systolic blood pressure
Time frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
Diastolic blood pressure
Time frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
Blood flow on dialysis
Time frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 29904224Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018 Jun 1;96(6):414-422D. doi: 10.2471/BLT.17.206441. Epub 2018 Apr 20.
- Background: PubMed 19861670de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
- Background: PubMed 28723862Komaki Y, Komaki F, Micic D, Ido A, Sakuraba A. Risk of Colorectal Cancer in Chronic Kidney Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2018 Oct;52(9):796-804. doi: 10.1097/MCG.0000000000000880.
- Background: PubMed 22977214Williams AW, Dwyer AC, Eddy AA, Fink JC, Jaber BL, Linas SL, Michael B, O'Hare AM, Schaefer HM, Shaffer RN, Trachtman H, Weiner DE, Falk AR; American Society of Nephrology Quality, and Patient Safety Task Force. Critical and honest conversations: the evidence behind the "Choosing Wisely" campaign recommendations by the American Society of Nephrology. Clin J Am Soc Nephrol. 2012 Oct;7(10):1664-72. doi: 10.2215/CJN.04970512. Epub 2012 Sep 13.
- Background: PubMed 25007790Abramowicz D, Cochat P, Claas FH, Heemann U, Pascual J, Dudley C, Harden P, Hourmant M, Maggiore U, Salvadori M, Spasovski G, Squifflet JP, Steiger J, Torres A, Viklicky O, Zeier M, Vanholder R, Van Biesen W, Nagler E. European Renal Best Practice Guideline on kidney donor and recipient evaluation and perioperative care. Nephrol Dial Transplant. 2015 Nov;30(11):1790-7. doi: 10.1093/ndt/gfu216. Epub 2014 Jul 9.
- Background: PubMed 12838225Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
- Background: PubMed 15758907Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
- Background: PubMed 12135020Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
- Background: PubMed 25595062ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.
- Background: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Background: PubMed 25239068Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
- Background: PubMed 22842619Connor A, Tolan D, Hughes S, Carr N, Tomson C. Consensus guidelines for the safe prescription and administration of oral bowel-cleansing agents. Gut. 2012 Nov;61(11):1525-32. doi: 10.1136/gutjnl-2011-300861. Epub 2012 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Di Leo, MD PhD principal investigator
University of Bari
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2-liters polyethylene glycol with citrate and simethicone, 4-liters polyethylene glycol with simethicone and Low-residue diet in people with Chronic Kidney Diseases and Colon Polyp, run by Alfredo Di Leo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfredo Di Leo, MD PhD (+39 080 5592925, alfredo.dileo@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate bowel preparation (time frame: During colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709770, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.