CompletedPhase 4

Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens

United States2,239 participantsStarted 2018-12-13

Plain-language summary

From the patients' perspective, the most formidable part of the colonoscopy experience is the process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to incompletion of scheduled colonoscopies which in turn undermines the effectiveness of colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel preparation in the VA is of larger volume and less palatable than another commonly used bowel preparation regimen. The investigators propose to compare these two commonly used bowel preparations with respect to the overall completion rate of scheduled colonoscopies in a real-world VA practice setting. The results of the study can be immediately applied to maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \> 18 years of age, and * being scheduled for outpatient elective screening, surveillance or diagnostic colonoscopies, and * the provider ordering the colonoscopy giving permission to enroll the patient. Exclusion Criteria: * Patients who are \<18 years * undergoing inpatient colonoscopy * those with contra-indications to receiving the standard 4L PEG-ELS colonoscopy bowel preparation (e.g., allergy to PEG) will be excluded * Those with a preference for a specific bowel preparation will be excluded. * The investigators are excluding inpatient colonoscopies because they account for a very small fraction of the total colonoscopies performed. * Also, inpatient colonoscopies are often performed for urgent reasons such that rapid bowel preparation procedures are followed. * In addition, because the objective of inpatient colonoscopy is often not to look for small polyps, the threshold for "adequate" bowel preparation quality might be different from that for outpatient procedures. * In addition, for patients undergoing more than 1 colonoscopy during the study period, only their first colonoscopy will be included in the primary analysis. * Patients who are undergoing a repeat colonoscopy for to a recent inadequate colonoscopy examination with poor bowel preparation will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Colonoscopy Completion Rate

Timeframe: This outcome is determined within 1 month after colonoscopy

Population Level Adenoma Detection Rate (ADR)

Timeframe: within 1 month of colonoscopy

Trial details

NCT IDNCT03298945

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-12-30

Results submitted2024-12-26

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