Morning-Only 4 L PEG vs Split Dose Prep for Afternoon Colonoscopies, Endoscopist-Blinded Prospective Study
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|ClinicalTrials.gov Identifier: NCT02643316|
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: Same day 4 L preparation (Polyethylene Glycol) Drug: Split dose 4 L preparation (Polyethylene Glycol)||Not Applicable|
The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.
Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: Same day 4 L preparation of PEG
Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy.
Drug: Same day 4 L preparation (Polyethylene Glycol)
Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.
Other Name: PEG bowel prep
Active Comparator: Split dose 4 L preparation of of the PEG
Receive the split-dose regimen. Will take half (2 L) of the PEG preparation the evening before colonoscopy and half (2 L) of the PEG preparation on the morning of the procedure.
Drug: Split dose 4 L preparation (Polyethylene Glycol)
Receive the split-dose regimen. Will take half (2 L) the preparation the evening before colonoscopy and half (2 L) on the morning of the procedure.
Other Name: PEG bowel prep
- Quality of preparation (Ottawa score) [ Time Frame: During the colonoscopy ]The quality of bowel preparation will be assessed for the 2 groups at the time of the colonoscopy using the Ottawa score for quality of preparation.
- Patient satisfaction with the bowel preparation (questionnaire). [ Time Frame: Before the colonoscopy procedure. ]Patient satisfaction with the bowel preparation in the 2 groups will be assessed using an approved questionnaire at the time of pre-operative assessment of the patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643316
|United States, Florida|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|Principal Investigator:||Fernando Castro, M.D.||Cleveland Clinic Florida|