Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426745
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Brief Title:
Split-dose Versus Single-dose Bowel Preparation for Colonoscopy
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Split-dose Versus Single-dose Bowel Preparation for Colonoscopy
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer IBD polyps and other conditions
Detailed Description:
Colonic cancers are a major concern in the Middle East and the world in general and every institute has attempted to initiate various clinical and investigatory procedures to detect the disease early in its development From 2005 till 2010 an audit conducted at the Royal Liverpool University revealed that out of 8910 colonoscopies 693 were incomplete 78 and for 25 of failure was because of inadequate bowel preparation
An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients The polyethylene glycol PEG solution an isosmotic non-absorbable polymer is generally used for bowel preparation because of its safety effectiveness and good tolerability Quality of bowel cleansing depends not only on the formula used but the preparation regimen also plays a role Split dosing of the laxative offers in general better cleansing than a single dose preparation
A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation
Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose in terms of adequate bowel preparation and polyp detection
On the other hand a large randomized trial of PEG regimens show low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated and acceptable bowel preparation for colonoscopy
A same-day dose of bowel cleanser has several benefits compared with split-dose or previous-day dose the fasting time is shorter and there is no sleep disturbance which can be associated with split-dose or previous-day regimen
An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients The polyethylene glycol PEG solution an isosmotic non-absorbable polymer is generally used for bowel preparation because of its safety effectiveness and good tolerability Quality of bowel cleansing depends not only on the formula used but the preparation regimen also plays a role Split dosing of the laxative offers in general better cleansing than a single dose preparation
A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation
Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose in terms of adequate bowel preparation and polyp detection
On the other hand a large randomized trial of PEG regimens show low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated and acceptable bowel preparation for colonoscopy
A same-day dose of bowel cleanser has several benefits compared with split-dose or previous-day dose the fasting time is shorter and there is no sleep disturbance which can be associated with split-dose or previous-day regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None