Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07215000

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location status: Recruiting

Location contact

Jesus Luevano Jr., M.D.

PRINCIPAL_INVESTIGATOR

Jesus Luevano, M.D.

CONTACT

[email protected]

404-971-9018

Julia Liu, M.D.

CONTACT

[email protected]

404-756-1389

Julia Liu, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: polyethylene glycol 3350, sodium sulfaten, potassium chloride, magnesium sulfate

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.

Primary outcomes

  1. Patient Experience

    Time frame: Until the end of the study

    Evaluate the patient experience of the two new colon prep options (low volume and tablets) versus conventional bowel prep in an out-patient setting.

  2. Edoscopic Adequacy

    Time frame: Until the end of the study

    Assess endoscopic adequacy of the three bowel cleansing solutions

Secondary outcomes

  1. Rate of Completion

    Time frame: Until the end of the study

    Determine the rate of completion for each colon prep option

Other outcomes

  1. Rate of cancellation and patient satisfaction and tolerance

    Time frame: Until the end of the study

    Compare rate of cancelation/missed rate, patient satisfaction and tolerance for the three colon preps.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia J Liu, MD, MSc

CONTACT

[email protected]

(404) 756-1369

Tasha Rhymes, M.S. Ed.

CONTACT

[email protected]

(404) 756-1369

Sponsors and collaborators

Lead sponsor

Morehouse School of Medicine

Other

Registry information

Official study title

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

Acronym: COOP SIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.