Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Golytely, Sulfave, Sutab.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Screening, Bowel Cleansing for Colonoscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cleansing Options in Outpatient Setting to Improve Tolerance (COOP SIT) Trial
Overview
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.
Interventions
- Drug Golytely
large volume liquid prep. - Drug Sulfave
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. - Drug 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 measures
- Patient Experience [Time frame: Until the end of the study]
- Edoscopic Adequacy [Time frame: Until the end of the study]
Secondary outcome measures (1)
- Rate of Completion [Time frame: Until the end of the study]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Morehouse School of Medicine — Atlanta
Publications
- Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. PMID 19136102
- Appannagari A, Mangla S, Liao C, Reddy KG, Kupfer SS. Risk factors for inadequate colonoscopy bowel preparations in African Americans and whites at an urban medical center. South Med J. 2014 Apr;107(4):220-4. doi: 10.1097/SMJ.0000000000000087. PMID 24937514
- Pullens HJ, Siersema PD. Quality indicators for colonoscopy: Current insights and caveats. World J Gastrointest Endosc. 2014 Dec 16;6(12):571-83. doi: 10.4253/wjge.v6.i12.571. PMID 25512766
- Hernandez PV, Horsley-Silva JL, Snyder DL, Baffy N, Atia M, Koepke L, Buras MR, Lim ES, Ruff K, Umar SB, Islam S, Ramirez FC. Effect of bowel preparation volume in inpatient colonoscopy. Results of a prospective, randomized, comparative pilot study. BMC Gastroenterol. 2020 Jul 13;20(1):227. doi: 10.1186/s12876-020-01373-1. PMID 32660521
- Ahmad A, Marshall S, Bassett P, Thiruvilangam K, Dhillon A, Saunders BP. Evaluation of bowel preparation regimens for colonoscopy including a novel low volume regimen (Plenvu): CLEANSE study. BMJ Open Gastroenterol. 2023 Mar;10(1):e001070. doi: 10.1136/bmjgast-2022-001070. PMID 36944438
- Vemulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689. PMID 35324481
- Chien C, Morimoto LM, Tom J, Li CI. Differences in colorectal carcinoma stage and survival by race and ethnicity. Cancer. 2005 Aug 1;104(3):629-39. doi: 10.1002/cncr.21204. PMID 15983985
- Primm KM, Malabay AJ, Curry T, Chang S. Who, where, when: Colorectal cancer disparities by race and ethnicity, subsite, and stage. Cancer Med. 2023 Jul;12(13):14767-14780. doi: 10.1002/cam4.6105. Epub 2023 May 22. PMID 37212502
Identifiers
NCT: NCT07215000 · 2282829