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

Conditions

• Bowel Cleansing for Colonoscopy
• Colorectal Cancer Screening

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Golytely — DRUG
  large volume liquid prep.
• Sulfave — DRUG
  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.
• Sutab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Oct 1, 2025

Status verified

Oct 2025

Primary completion

Jan 31, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Active Comparator: Golytely
  GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.
• Other: Sulfave
  Suflave is a combination, osmotic prescription laxative that may be used to cleanse the bowel in preparation for colonoscopy in adults. Suflave contains polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride, and is supplied as a powder that is mixed with a low volume of water before consuming. It tastes like a lemon-lime sports drink. Drink 8 ounces of the solution every 15 minutes until the bottle is empty, and then drink an additional 16 ounces of water during the evening. One dose of Suflave is equal to one bottle plus one flavor-enhancing packet.
• Other: Sutab
  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.

Primary Outcome Measure

Patient Experience [ Time Frame: Until the end of the study ]

Central Contacts

• Julia J Liu, MD, MSc
  (404) 756-1369
  [email protected]
• Tasha Rhymes, M.S. Ed.
  (404) 756-1369
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

Related Studies

• Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings
  Enrolling By Invitation · Rutgers, The State University of New Jersey · New Brunswick, New Jersey
• Impact of Protect Your Colon™ on CRC Screening
  Recruiting · Cedars-Sinai Medical Center · Los Angeles, California
• Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening
  Enrolling By Invitation · Icahn School of Medicine at Mount Sinai · New York, New York
• Patient Navigation for Colorectal Cancer Screening
  Enrolling By Invitation · Medstar Health Research Institute · Washington D.C., District of Columbia