Efficacy, Safety, and Tolerability of MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy: a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Number of Participants With Adequate Bowel Preparation
研究概览
简要总结
Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or greater
- •Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone)
- •Ability to take bowel preparation and be willing to adhere to the regimen
排除标准
- •Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
- •Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
- •Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon
- •Unable to give informed consent to the procedure
- •Known glucose-6-phosphate dehydrogenase deficiency
- •Known phenylketonuria
- •Known hypersensitivity to polyethylene glycols or ascorbic acid
- •Patients undergoing colonoscopy for foreign body removal and/or decompression
- •Pregnancy or lactating women
研究组 & 干预措施
MoviPrep
For MoviPrep, the dose, schedule, and route of administration are as follows:
- On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
- On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
- Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
- Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
干预措施: MoviPrep (Drug)
GoLYTELY
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
- On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
- Drink the remaining 2 liters on the morning of the procedure.
- Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
- Avoid red and purple liquids.
干预措施: Golytely (Drug)
结局指标
主要结局
Number of Participants With Adequate Bowel Preparation
时间窗: At time of procedure, approximately 45 minutes
The Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2.
次要结局
- Cecal Intubation Time(At time of procedure, approximately 45 minutes)
- Colonoscopy Withdrawal Time(At time of procedure, approximately 45 minutes)
- Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment(At time of procedure, approximately 45 minutes)
- Number of Participants With "Excellent" Bowel Preparation(At time of procedure, approximately 45 minutes)
- Cecal Intubation(At time of procedure, approximately 45 minutes)
- Time to Colonoscopy(From start of prep to time of procedure, up to 21 hours)
- Hospital Length of Stay(After study completion, an average of 10 days)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(Through study completion, an average of 3 days)
- Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6(Immediately prior to procedure)
- Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7(Immediately prior to procedure)