Bowel Preparation Solutions
Conditions
Keywords
Golytely, Clenpiq, bowel prep
Brief summary
This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.
Detailed description
The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than a low volume bowel preparation, and if the time of dosing (single dose night before vs split dose) of the bowel preparation results in better bowel cleansing in participants undergoing colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy with general anesthesia will be randomized only to the single dose arms of the study. Participants will complete a questionnaire while drinking the bowel preparation to determine timing and tolerability of the bowel preparation.
Sponsors
Ferring Pharmaceuticals
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants will be receive either Golytely or Clenpiq bowel prep solutions. Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the colonoscopy procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.
Exclusion criteria
* Creatinine clearance less than 30 ml/min * History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction * Small bowel obstruction, ileus or bowel perforation * Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study. * Gastroparesis * Toxic megacolon or undergoing colonoscopy for decompression * Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours * History of prior colorectal surgery * Allergy to any of the ingredients in Clenpiq or golytely * if the procedure is planned in the intensive care unit (ICU)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Satisfactory Bowel Cleansing | 1 day | Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire mucosa is seen well with no residual staining, small fragments of stool or opaque liquid). A total BBPS score of 6 or greater AND 2 or greater in all segments will be defined as satisfactory bowel prep. BBPS score of less than 6 or less than 2 in any segment of the colon will be taken as unsatisfactory bowel cleansing in the final analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Requiring a Repeat Colonoscopy | 1 day | Participants requiring a repeat procedure due to unsatisfactory bowel prep |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.
Golytely: bowel preparation | 3 |
| Group B Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.
Golytely: bowel preparation | 2 |
| Group C Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.
Clenpiq: bowel preparation | 7 |
| Group D Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.
Clenpiq: bowel preparation | 2 |
| Total | 14 |
Baseline characteristics
| Characteristic | Group A | Total | Group D | Group C | Group B |
|---|---|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 12.7 | 52.1 years STANDARD_DEVIATION 18.7 | 58.0 years STANDARD_DEVIATION 22.6 | 51.7 years STANDARD_DEVIATION 21.9 | 42.5 years STANDARD_DEVIATION 23.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 12 Participants | 1 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 0 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 2 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 | 0 / 7 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 | 0 / 7 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 | 0 / 7 | 0 / 2 |
Outcome results
Primary
Percentage of Participants With Satisfactory Bowel Cleansing
Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire mucosa is seen well with no residual staining, small fragments of stool or opaque liquid). A total BBPS score of 6 or greater AND 2 or greater in all segments will be defined as satisfactory bowel prep. BBPS score of less than 6 or less than 2 in any segment of the colon will be taken as unsatisfactory bowel cleansing in the final analysis.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Percentage of Participants With Satisfactory Bowel Cleansing | 2 Participants |
| Group B | Percentage of Participants With Satisfactory Bowel Cleansing | 2 Participants |
| Group C | Percentage of Participants With Satisfactory Bowel Cleansing | 4 Participants |
| Group D | Percentage of Participants With Satisfactory Bowel Cleansing | 2 Participants |
Secondary
Proportion of Participants Requiring a Repeat Colonoscopy
Participants requiring a repeat procedure due to unsatisfactory bowel prep
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Proportion of Participants Requiring a Repeat Colonoscopy | 0 Participants |
| Group B | Proportion of Participants Requiring a Repeat Colonoscopy | 0 Participants |
| Group C | Proportion of Participants Requiring a Repeat Colonoscopy | 0 Participants |
| Group D | Proportion of Participants Requiring a Repeat Colonoscopy | 0 Participants |