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Идёт набор NCT07215000

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

Фаза IV С лечением Colorectal Cancer Screening Bowel Cleansing for Colonoscopy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Golytely, Sulfave, Sutab.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer Screening, Bowel Cleansing for Colonoscopy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Golytely
    large volume liquid prep.
  • Препарат 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.
  • Препарат 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.

Первичные конечные точки

  • Patient Experience [Срок оценки: Until the end of the study]
  • Edoscopic Adequacy [Срок оценки: Until the end of the study]
Вторичные конечные точки (1)
  • Rate of Completion [Срок оценки: Until the end of the study]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Morehouse School of Medicine — Atlanta

Публикации

  • 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

Идентификаторы

NCT: NCT07215000 · 2282829

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗