A Phase 3 interventional study of Polyethylene Glycol afternoon and Polyethylene Glycol morning in Colon Cancer, sponsored by Cleveland Clinic Florida. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Cleveland Clinic Florida · Phase 3, Interventional, and Treatment
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 136 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Cleveland Clinic Florida is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon'
Drug: Polyethylene Glycol afternoon
Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning'
Drug: Polyethylene 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 Evening prep, between 5PM and 9PM
Also known as: GoLytely
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
Also known as: Golytely
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
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
| Milestone | Evening | Morning |
|---|---|---|
| Started | 68 | 68 |
| Completed | 68 | 68 |
| Not completed | 0 | 0 |
| units on a scale | Evening | 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. | 7.1 ± 2.7 | 4.7 ± 2.4 |
Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.
| participants | Evening | Morning |
|---|---|---|
| Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. | 21 | 11 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evening | — | 0/68 (0%) | 0/68 (0%) |
| Morning | — | 0/68 (0%) | 0/68 (0%) |
| Age, Continuous(years) | Evening | Morning | Total |
|---|---|---|---|
| Mean | 52.2 ± 11.5 | 51.4 ± 10.2 | 51.8 ± 10.8 |
| Sex: Female, Male(Participants) | Evening | Morning | Total |
|---|---|---|---|
| Female | 30 | 35 | 65 |
| Male | 38 | 33 | 71 |
Plan to share: No
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