Cleansing options to improve colonoscopy tolerance
Cleansing Options in Outpatient Setting to Improve Tolerance (COOP SIT) Trial
This test compares low-volume tablet bowel preps (Sutab/Suflave) with standard Golytely for adults having outpatient colonoscopies to see which is better tolerated and preferred.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Morehouse School of Medicine Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07215000 on ClinicalTrials.gov |
What this trial studies
About 300 adults scheduled for outpatient colonoscopy will be randomized in a 2:1 ratio to receive either a low-volume tablet preparation (Sutab/Suflave) or standard polyethylene glycol solution (Golytely). Participants will complete brief surveys before and after their procedures over a 12-month enrollment period to capture completion rates, satisfaction, and tolerability. Endoscopists will rate bowel cleanliness to compare the endoscopic adequacy of each method. The trial will compare patient-reported experience and objective cleansing outcomes between the two prep strategies.
Who should consider this trial
Good fit: Adults aged 18 and older scheduled for outpatient colonoscopy who can provide informed consent in English or Spanish are ideal candidates.
Not a fit: Pregnant or nursing people, those under 18, incarcerated individuals, or anyone unable to give informed consent would not be eligible and thus would not benefit from participating.
Why it matters
Potential benefit: If successful, a more tolerable prep could make bowel cleansing easier, increase completion rates, and improve the quality of colonoscopy screenings.
How similar studies have performed: Prior trials have shown low-volume tablet preps like Sutab can provide similar cleansing efficacy to PEG solutions and are often better tolerated and preferred by patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia
- Morehouse School of Medicine — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jesus M Luevano, MD, MS — Morehouse School of Medicine
- Study coordinator: Julia J Liu, MD, MSc
- Email: jjliu@msm.edu
- Phone: (404) 756-1369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.