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

Morehouse School of Medicine

Status and phase: Enrolling; Phase 4

Conditions: Bowel Cleansing for Colonoscopy; Colorectal Cancer Screening

Treatments: Drug: Sutab; Drug: Golytely; Drug: Sulfave

Study type: Interventional

Funder types: Other

Identifiers

NCT07215000

2282829

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Golytely

Active Comparator group

Description:

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.

Treatment:

Drug: Golytely

Sulfave

Other group

Description:

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.

Treatment:

Drug: Sulfave

Sutab

Other group

Description:

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.

Treatment:

Drug: Sutab