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

January 13, 2021 updated by: Alfredo Di Leo

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-volume preparation

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
Low-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Other Names:
  • Clensia
Dietary supplement: Low-residue diet
Diet before colonoscopy.
Active Comparator: High-volume preparation

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.
Dietary supplement: Low-residue diet
Diet before colonoscopy.
Drug: 4-liters polyethylene glycol with simethicone
High-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Other Names:
  • Selg Esse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate bowel preparation
Time Frame: During colonoscopy
Proportion of participants with Boston Bowel Preparation Scale ≥6 with each segmental score ≥2
During colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: During colonoscopy
Proportion of patients with at least one adenoma
During colonoscopy
Cecal intubation rate
Time Frame: During colonoscopy
Proportion of endoscopic examinations reaching the cecum
During colonoscopy
Participants' compliance
Time Frame: During colonoscopy
Proportion of participants with intake of at least 75 percent of the bowel preparation
During colonoscopy
Participants' tolerability
Time Frame: During colonoscopy
Proportion of participants presenting nausea, bloating, vomiting, abdominal pain, and/or anal irritation
During colonoscopy
Willingness to repeat the preparation
Time Frame: During colonoscopy
Proportion of participants willing to use the same bowel preparation for future examinations
During colonoscopy
Adverse events
Time Frame: During colonoscopy and the first hemodialysis session following colonoscopy
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
Time Frame: Within a 30-day period
Proportion of participants hospitalized after bowel preparation intake for any cause
Within a 30-day period
All-cause mortality
Time Frame: Within a 30-day period
Proportion of participants who died after bowel preparation intake for any cause
Within a 30-day period
Emergency hemodialysis sessions
Time Frame: Within a 30-day period
Proportion of participants needing additional hemodialysis sessions
Within a 30-day period
Cardiovascular events
Time Frame: Within a 30-day period
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
Time Frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
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
Time Frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
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
Time Frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
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
Time Frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
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
Time Frame: During the hemodialysis session preceding and the one following the intake of bowel preparation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfredo Di Leo

Collaborators

Alfasigma S.p.A.

Investigators

  • Principal Investigator: Alfredo Di Leo, MD PhD, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Policlinic Hospital 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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