Efficacy of a Low Volume PEG Purgative (MoviPrep®) Administered Entirely in the Morning Compared to Split Dose (PM/AM) Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Comparing the efficacy of AM dose only MoviPrep® (1/2 the prep 7 hrs pre colonoscopy and the second 1/2 4 hrs pre colonoscopy), versus PM/AM where 1/2 of the prep is at 6pm the night prior to colonoscopy and the second half is 4 hours before colonoscopy.
研究概览
简要总结
This study will evaluate whether morning-only dosing of MoviPrep® (2L) for afternoon colonoscopy is as effective as a standard dosing regimen of half of the volume of MoviPrep® (1L) solution the evening prior, and half (1L) the morning of, colonoscopy. MoviPrep® is a low volume (2 liters) polyethylene glycol (PEG)-based purgative that is approved for evening-only or split (evening and morning) dosing to cleanse the colon prior to colonoscopy. Patients undergoing afternoon colonoscopies often have inferior colon cleansing. There is evidence that morning-only purgative administration of large volume PEG (4L) is safe and effective. This study will assess whether administration of a low volume PEG regimen will maintain efficacy and improve tolerance by changing a 2-day preparation procedure into a regimen that is completed in 1 day.
详细描述
primary objectives
• To compare the efficacy of morning dose only MoviPrep® ("AM Dosing") where one-half of the prep is given 7 hours before colonoscopy and the second half is given 4 hours before colonoscopy, versus split dose (PM/AM) MoviPrep® ("PM/AM Dosing") where one-half of the prep is given at 6pm the night prior to colonoscopy and the second half is given 4 hours before colonoscopy.
Efficacy will be assessed based on cleansing of the entire colon, with successful cleansing defined as a score of excellent or good and unsuccessful cleansing defined as a score of fair or poor.
Secondary objectives
- To assess the tolerability of AM Dosing MoviPrep® versus PM/AM Dosing MoviPrep® based on percentage of prep completed, sleep quality/quantity, future prep choice (same prep or alternative prep described), and incidence and severity (using 11-point Likert scale) of any adverse events (i.e. nausea, vomiting, abdominal pain, bloating, light-headedness).
- To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy.
- To evaluate the effect of colon prep on work and productivity as measured by the degree of interference with work/productivity the day prior to colonoscopy.
- To assess difference between two dosing arms with respect to analysis of right colon cleansing, and overall adenoma detection in terms of number, size, location, histology, and morphology.
- To determine the effect of purgative dosing on procedure efficiency by measuring (a) total procedure time, (b) time from anus to cecum, and (c) withdrawal time (excluding time taken for interventions).
- To evaluate the effect of purgative dosing regimen on amount of flushing required during the procedure (0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml).
- To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Elective out-patients scheduled for afternoon colonoscopy (12 pm or later).
排除标准
- •Unable or unwilling to consent
- •Age < 18 years
- •Breast feeding
- •Gastroparesis - known or suspected
- •Chronic nausea or vomiting
- •Bowel obstruction
- •Hypomotility syndrome: pseudo-obstruction, megacolon, etc.
- •Severe constipation (< 1 BM a week)
- •Greater than 50% resection of colon
- •Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
- •PEG allergy
- •Significant psychiatric illness
结局指标
主要结局
Comparing the efficacy of AM dose only MoviPrep® (1/2 the prep 7 hrs pre colonoscopy and the second 1/2 4 hrs pre colonoscopy), versus PM/AM where 1/2 of the prep is at 6pm the night prior to colonoscopy and the second half is 4 hours before colonoscopy.
时间窗: once
次要结局
- To assess the tolerability of AM Dosing MoviPrep® versus PM/AM Dosing MoviPrep® based on % of prep completed, sleep quality/quantity, future prep choice (same prep or alternative prep described), and incidence and severity of any adverse events(once)
- To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy(once)
- To evaluate the effect of colon prep on work and productivity as measured by the degree of interference with work/productivity the day prior to colonoscopy.(once)
- To assess difference between two dosing arms with respect to analysis of right colon cleansing, and overall adenoma detection in terms of number, size, location, histology, and morphology.(once)
- To determine the effect of purgative dosing on procedure efficiency by measuring (a) total procedure time, (b) time from anus to cecum, and (c) withdrawal time (excluding time taken for interventions).(once)
- To evaluate the effect of purgative dosing regimen on amount of flushing required during the procedure (0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml).(once)
- To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.(once)