Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMorehouse School of Medicine
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.
Trial design
Design model
Single group
Treatments tested in this trial
Golytely
Druglarge volume liquid prep.
Sulfave
DrugSUFLAVE 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
DrugSUTAB 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 groups
300 Participants
are divided into 3 treatment groupsGroup A: GolytelyActive comparator 1 intervention
Group B: SulfaveOther 1 intervention
Group C: SutabOther 1 intervention
Trial outcomes
Primary outcomes
1
Patient Experience
Evaluate the patient experience of the two new colon prep options (low volume and tablets) versus conventional bowel prep in an out-patient setting.
Time frame
Until the end of the study2
Edoscopic Adequacy
Assess endoscopic adequacy of the three bowel cleansing solutions
Time frame
Until the end of the studySecondary outcomes
1
Rate of Completion
Determine the rate of completion for each colon prep option
Time frame
Until the end of the studyOther outcomes
1
Rate of cancellation and patient satisfaction and tolerance
Compare rate of cancelation/missed rate, patient satisfaction and tolerance for the three colon preps.
Time frame
Until the end of the studySponsors and contacts
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Source ClinicalTrials.gov