SUPREP vs Golytely for Colon Cancer Screening
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two bowel cleansing treatments, Golytely and SUPREP, to determine which is more effective for colon cancer screening in people with diabetes. Researchers aim to identify any differences in bowel cleansing efficacy and patient tolerability between the treatments. Participants will be randomly assigned to use one of the two preparations before their colonoscopy. The trial seeks diabetic adults undergoing routine colon cancer screening with no history of colorectal surgery or inflammatory bowel disease. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What is the safety track record for Golytely and SUPREP?
Research has shown that both Golytely and SUPREP are safe options for bowel cleansing before a colonoscopy. Studies suggest that SUPREP might be more effective and easier to tolerate than Golytely. Both are widely used, and most people tolerate them well.
One study found that SUPREP is less likely to result in an incomplete bowel prep compared to Golytely, making it potentially easier for some people to use. Another study found no major differences in safety between the two. Both are common choices for colonoscopy prep, and serious side effects are rare.
While both are generally safe, individual experiences can vary. Participants should discuss any concerns with their healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because SUPREP and Golytely offer distinct approaches to bowel preparation for colonoscopy, particularly for diabetic patients. Unlike the standard options, which often include polyethylene glycol solutions like Golytely, SUPREP is sulfate-based, potentially offering a more tolerable taste and better patient compliance. These differences could lead to improved preparation quality and a more comfortable experience for patients, which is crucial for effective colon cancer screening. By exploring these alternatives, researchers hope to enhance the overall effectiveness and acceptance of colonoscopy procedures.
What evidence suggests that this trial's treatments could be effective for bowel cleansing in diabetic patients?
In this trial, diabetic patients will prepare for screening colonoscopy using either SUPREP or Golytely. Previous studies have shown that SUPREP effectively cleans the colon before a colonoscopy. Specifically, research found that patients using SUPREP had a 48% lower chance of an inadequately cleaned colon compared to those using Golytely. This suggests that SUPREP generally prepares the colon better for the procedure. The FDA has approved SUPREP for colon cleansing, supporting its effectiveness. While Golytely is also effective, SUPREP might be easier for patients to tolerate, making it more comfortable to use.12346
Are You a Good Fit for This Trial?
This trial is for diabetic patients who need a colonoscopy to screen for colon cancer. Participants will be randomly assigned to use either Golytely or SUPREP bowel prep. They must complete a tolerability form and undergo the screening where a doctor, unaware of which prep they used, scores the cleanliness of their bowels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants are randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy
Colonoscopy Procedure
Participants undergo a standardized screening colonoscopy during which a blinded endoscopist will document the participant's BBPS
Follow-up
Participants are monitored for any immediate post-procedural effects and tolerability is assessed using the Mayo Bowel Prep Tolerability Form
What Are the Treatments Tested in This Trial?
Interventions
- Golytely
- SUPREP
Trial Overview
The study compares two bowel cleansing methods—Golytely and SUPREP—to see which one works better for diabetics before a colonoscopy. It measures how well each cleans out the bowels using the Boston Bowel Prep Score and checks patient comfort with the Mayo Bowel Prep Tolerability Form.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eisenhower Army Medical Center
Lead Sponsor
Citations
Comparative Effectiveness of Commercial Bowel Preparations ...
After adjusting for these factors, compared to GoLYTELY, patients receiving SuPREP and NuLYTELY had 48% and 35% reduced odds of having IBP.
NCT02523911 | Efficacy and Tolerability of Suprep With ...
The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient ...
NDA/BLA Multi-Disciplinary Review and Evaluation ( ...
approval of Suprep Bowel Prep Kit for cleansing of the colon in preparation for colonoscopy in ... • The safety and effectiveness of Suprep Bowel ...
Optimizing Bowel Preparation Quality for Colonoscopy
This document is an update to the 2014 recommendations for optimizing the adequacy of bowel cleansing for colonoscopy from the US Multi-Society ...
5.
journals.lww.com
journals.lww.com/ajg/fulltext/2024/10000/impact_of_bowel_preparation_quality_on_colonoscopy.22.aspxImpact of Bowel Preparation Quality on Colonoscopy ...
Overall, 125,439 (37%) colonoscopies had excellent bowel preparation, 159,719 (48%) had good bowel preparation, 37,943 (11%) had fair bowel preparation, 9,440 ( ...
554 Comparative Effectiveness of Colonoscopy Bowel ...
Our data suggests Golytely® is not as effective as other 4L PEG solutions, Moviprep® or Suprep®. In an era where reimbursement is tied to quality, using the ...
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