Colon Cancer
Conditions
Keywords
Afternoon colonoscopy, Morning, Evening, Bowel Preparation, Efficacy, Satisfaction
Brief summary
The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.
Detailed description
Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as Golytely will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.
Interventions
DRUGPolyethylene Glycol afternoon
Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
DRUGPolyethylene Glycol morning
Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM
Sponsors
Cleveland Clinic Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon.
Exclusion criteria
* Colonoscopy is contraindicated * Prior Colectomy or colon surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome. | Within 1 hr after the colonoscopy procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. | An hour before the colonoscopy procedure | Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evening Bowel prep given in the evening prior to the day of the afternoon colonoscopy | 68 |
| Morning Bowel prep given on the morning of the day of the afternoon colonoscopy | 68 |
| Total | 136 |
Baseline characteristics
| Characteristic | Evening | Morning | Total |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.5 | 51.4 years STANDARD_DEVIATION 10.2 | 51.8 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 30 Participants | 35 Participants | 65 Participants |
| Sex: Female, Male Male | 38 Participants | 33 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 | 0 / 68 |
Outcome results
Primary
Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.
Time frame: Within 1 hr after the colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evening | Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome. | 7.1 units on a scale | Standard Deviation 2.7 |
| Morning | Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome. | 4.7 units on a scale | Standard Deviation 2.4 |
p-value: <0.01t-test, 2 sided
Secondary
Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.
Time frame: An hour before the colonoscopy procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evening | Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. | 21 participants |
| Morning | Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. | 11 participants |
p-value: 0.04Chi-squared