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

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

Inclusion Criteria1

  • Adults over age of 18 years undergoing outpatient colonoscopy for various indications, ability to consent in English or Spanish. Patients will still be allowed to join if there is a history of colorectal cancer or previous surgery

Exclusion Criteria1

  • Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.

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.


Locations(1)

Morehouse School of Medicine

Atlanta, Georgia, United States

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NCT07215000


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