Clinical trial NCT00929916: Comparing Two Different Ways to Take MoviPrep® Before Colonoscopy
Official title: Efficacy of a Low Volume PEG Purgative (MoviPrep®) Administered Entirely in the Morning Compared to Split Dose (PM/AM) Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Keywords: colonoscopy
MoviPrep
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2009-06-30
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: out-patients scheduled for afternoon colonoscopy in the Thomas Jefferson GI group

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Elective out-patients scheduled for afternoon colonoscopy (12 pm or later).

Exclusion Criteria:

* Unable or unwilling to consent
* Age \< 18 years
* Pregnant
* 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

Primary outcomes:
measure: 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.
timeFrame: once
Secondary outcomes:
measure: 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
timeFrame: once
measure: To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy
timeFrame: once
measure: 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.
timeFrame: once
measure: 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.
timeFrame: once
measure: 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).
timeFrame: once
measure: 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).
timeFrame: once
measure: To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.
timeFrame: once
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David M Kastenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: