Trial Outcomes & Findings for The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies (NCT NCT01978509)
NCT ID: NCT01978509
Last Updated: 2020-07-17
Results Overview
Measured using the total Boston Bowel Prep Score (BBPS) obtained by adding scores from each segment for a range of minimum 0 = very poor and maximum 9 = excellent.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
24 hours
Results posted on
2020-07-17
Participant Flow
Participant milestones
| Measure |
Low Volume Prep (Prepopik)
Low volume prep for colonoscopy (Prepopik)
Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
Moderate Volume Prep (Moviprep)
Moderate volume prep for colonoscopy (Moviprep)
Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
High Volume Prep (Golytely)
High volume prep for colonoscopy (Golytely)
High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Moderate Volume Prep (Moviprep)
n=13 Participants
Moderate volume prep for colonoscopy (Moviprep)
Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
High Volume Prep (Golytely)
n=9 Participants
High volume prep for colonoscopy (Golytely)
High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
Total
n=32 Participants
Total of all reporting groups
|
Low Volume Prep (Prepopik)
n=10 Participants
Low volume prep for colonoscopy (Prepopik)
Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
|---|---|---|---|---|
|
Age, Continuous
|
56.13 years
STANDARD_DEVIATION 19.08 • n=13 Participants
|
70.78 years
STANDARD_DEVIATION 12.33 • n=9 Participants
|
63.66 years
STANDARD_DEVIATION 17.65 • n=32 Participants
|
67 years
STANDARD_DEVIATION 17.54 • n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
3 Participants
n=9 Participants
|
12 Participants
n=32 Participants
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
6 Participants
n=9 Participants
|
20 Participants
n=32 Participants
|
8 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
9 participants
n=9 Participants
|
32 participants
n=32 Participants
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 24 hoursMeasured using the total Boston Bowel Prep Score (BBPS) obtained by adding scores from each segment for a range of minimum 0 = very poor and maximum 9 = excellent.
Outcome measures
| Measure |
Low Volume Prep (Prepopik)
n=8 Participants
Low volume prep for colonoscopy (Prepopik)
Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
Moderate Volume Prep (Moviprep)
n=8 Participants
Moderate volume prep for colonoscopy (Moviprep)
Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
High Volume Prep (Golytely)
n=9 Participants
High volume prep for colonoscopy (Golytely)
High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
|---|---|---|---|
|
Bowel Cleansing
|
7.4 score on a scale
Standard Deviation 1.62
|
6.9 score on a scale
Standard Deviation 1.55
|
7.0 score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Study was terminated due to lack of enrollment and data not collected.
To assess the rate of delayed and or cancellation of procedure due to inadequate bowel preparation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPercentage of participants self-reporting finishing the bowel preparation
Outcome measures
| Measure |
Low Volume Prep (Prepopik)
n=8 Participants
Low volume prep for colonoscopy (Prepopik)
Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
Moderate Volume Prep (Moviprep)
n=8 Participants
Moderate volume prep for colonoscopy (Moviprep)
Moderate volume prep (Moviprep): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
High Volume Prep (Golytely)
n=9 Participants
High volume prep for colonoscopy (Golytely)
High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
|
|---|---|---|---|
|
Patient Tolerance
|
100 percentage of participants
|
75 percentage of participants
|
77.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPopulation: Study was terminated due to lack of enrollment and data not collected.
Assess the success of cecal intubation rate between three bowel preparations.
Outcome measures
Outcome data not reported
Adverse Events
Low Volume Prep (Prepopik)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Volume Prep (Moviprep)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Volume Prep (Golytely)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place