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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golytely | Active Comparator | 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. |
|
| Sulfave | Other | 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. |
|
| Sutab | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golytely | Drug | large volume liquid prep. |
| |
| Sulfave |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until the end of the study |
| Edoscopic Adequacy | Assess endoscopic adequacy of the three bowel cleansing solutions | Until the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Completion | Determine the rate of completion for each colon prep option | Until the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cancellation and patient satisfaction and tolerance | Compare rate of cancelation/missed rate, patient satisfaction and tolerance for the three colon preps. | Until the end of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia J Liu, MD, MSc | Contact | (404) 756-1369 | jjliu@msm.edu | |
| Tasha Rhymes, M.S. Ed. | Contact | (404) 756-1369 | trhymes@msm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jesus M Luevano, MD, MS | Morehouse School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morehouse School of Medicine | Recruiting | Atlanta | Georgia | 30310 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19136102 | Background | 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. | |
| 24937514 | Background | 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. |
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| ID | Term |
|---|---|
| C033608 | Golytely |
| C000595212 | polyethylene glycol 3350 |
| D011189 | Potassium Chloride |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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. |
|
|
| 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. |
|
| 25512766 | Background | 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. |
| 32660521 | Background | 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. |
| 36944438 | Background | 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. |
| 35324481 | Background | 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. |
| 15983985 | Background | 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. |
| 37212502 | Background | 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. |
| 21128280 | Background | Ollberding NJ, Nomura AM, Wilkens LR, Henderson BE, Kolonel LN. Racial/ethnic differences in colorectal cancer risk: the multiethnic cohort study. Int J Cancer. 2011 Oct 15;129(8):1899-906. doi: 10.1002/ijc.25822. Epub 2011 Mar 25. |
| 27138583 | Background | Holowatyj AN, Ruterbusch JJ, Rozek LS, Cote ML, Stoffel EM. Racial/Ethnic Disparities in Survival Among Patients With Young-Onset Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2148-56. doi: 10.1200/JCO.2015.65.0994. Epub 2016 May 2. |
| 36633525 | Background | Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. |
| D017680 |
| Potassium Compounds |
| D017616 | Magnesium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |