Colonoscopy
Conditions
Keywords
Colonoscopy
Brief summary
The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.
Interventions
DRUGLow 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.
DRUGModerate 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.
DRUGHigh 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Inpatient colonoscopy 2. Age 18 years and older 3. Able to give consent 4. Split dose colonoscopies for all patients
Exclusion criteria
1. Unable to give consent 2. Pregnant or lactating women 3. Renal impairment (GFR \<30) 4. Ileus 5. Ascites 6. Toxic megacolon 7. Gastrointestinal obstruction 8. Allergy to study drugs 9. Toxic colitis 10. Not able to split the dose of bowel preparations to be used 11. Contraindication to bowel preparation 12. Risk for aspiration 13. Risk of severe cardiac arrhythmias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Cleansing | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancellation or Delay of Procedure Due to Poor Bowel Preparation | 24 hours | To assess the rate of delayed and or cancellation of procedure due to inadequate bowel preparation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerance | 24 hours | Percentage of participants self-reporting finishing the bowel preparation |
| Cecal Intubation | 24 hours | Assess the success of cecal intubation rate between three bowel preparations. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 13 |
| 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. | 9 |
| Total | 32 |
Baseline characteristics
| Characteristic | Moderate Volume Prep (Moviprep) | High Volume Prep (Golytely) | Total | Low Volume Prep (Prepopik) |
|---|---|---|---|---|
| Age, Continuous | 56.13 years STANDARD_DEVIATION 19.08 | 70.78 years STANDARD_DEVIATION 12.33 | 63.66 years STANDARD_DEVIATION 17.65 | 67 years STANDARD_DEVIATION 17.54 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 13 participants | 9 participants | 32 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 12 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 20 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 13 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 13 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 13 | 0 / 9 |
Outcome results
Primary
Bowel Cleansing
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Volume Prep (Prepopik) | Bowel Cleansing | 7.4 score on a scale | Standard Deviation 1.62 |
| Moderate Volume Prep (Moviprep) | Bowel Cleansing | 6.9 score on a scale | Standard Deviation 1.55 |
| High Volume Prep (Golytely) | Bowel Cleansing | 7.0 score on a scale | Standard Deviation 1.41 |
p-value: 0.7ANOVA
Secondary
Cancellation or Delay of Procedure Due to Poor Bowel Preparation
To assess the rate of delayed and or cancellation of procedure due to inadequate bowel preparation
Time frame: 24 hours
Population: Study was terminated due to lack of enrollment and data not collected.
Other Pre-specified
Cecal Intubation
Assess the success of cecal intubation rate between three bowel preparations.
Time frame: 24 hours
Population: Study was terminated due to lack of enrollment and data not collected.
Other Pre-specified
Patient Tolerance
Percentage of participants self-reporting finishing the bowel preparation
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Volume Prep (Prepopik) | Patient Tolerance | 100 percentage of participants |
| Moderate Volume Prep (Moviprep) | Patient Tolerance | 75 percentage of participants |
| High Volume Prep (Golytely) | Patient Tolerance | 77.8 percentage of participants |