RecruitingPhase 4NCT07215000

Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial

Cleansing Options in Outpatient Setting to Improve Tolerance (COOP SIT) Trial

Sponsor

Morehouse School of Medicine

Enrollment

300 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Screening Bowel Cleansing for Colonoscopy

Summary

The purpose of this research is to compare patient preferences for two bowel preparation options: low-volume tablets (Suflave/Sutab) versus the standard colon preparation using Golytely (polyethylene glycol). The study aims to enroll approximately 300 patients, who will be randomly assigned to one of the two preparation methods in a 2:1 ratio prior to their scheduled colonoscopy appointments. Surveys will be conducted both before and after the procedures. This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method. Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called COOP SIT) is comparing different bowel preparation methods — the laxative drinks patients must take before a colonoscopy — to find out which is most tolerable and effective for patients doing the prep at home before an outpatient procedure. **You may be eligible if...** - You are 18 years old or older - You are scheduled for an outpatient colonoscopy for any reason - You can understand and consent in English or Spanish **You may NOT be eligible if...** - You are under 18 years old - You are pregnant or breastfeeding - You are incarcerated - You are unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGolytely

large volume liquid prep.

DRUGSulfave

SUFLAVE is a split-dose (2-day) regimen. A total of 2 bottles are required for complete preparation for colonoscopy. You will take 2 bottles of liquid in two separate doses. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.

DRUGSutab

SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.