Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275184
Status:
UNKNOWN
Last Update Posted:
2007-09-24
First Post:
2006-01-10
Brief Title:
Bowel Preparation and Prokinetics in Capsule Endoscopy
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
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:
The aim of this study is to determine whether taking bowel preparation citramag and senna or a medicine to speed up transit through the stomach metoclopramide will improve the quality of the images seen increase the transit through the small bowel and increase the rate of completion of capsule endoscopy
The secondary objective is to determine whether patients could routinely tolerate this bowel preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy is improved
The secondary objective is to determine whether patients could routinely tolerate this bowel preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy is improved
Detailed Description:
Capsule endoscopy is a diagnostic tool for the detection of small bowel disease allowing noninvasive endoscopic examination of the entire small bowel without the need for sedation Its limited battery life of 8-1 hours means it is paramount that the Capsule reaches the caecum visualizing the whole of the small intestine and also that the mucosal views obtained are clear facilitating detection of pathologic lesions
So far no optimal protocol for bowel preparation prior to Capsule endoscopy has been established Recently several studies have shown that bowel preparation with polyethylene glycol significantly reduces both gastric and small bowel transit times Similarly visualization of the small intestine and therefore diagnostic yield have both been shown to be improved by both sodium phosphate and polyethylene glycol preparation A more recent study by Selby et al also demonstrates that the prokinetic agent metoclopramide which is known to promote emptying of the stomach reduced both stomach and small bowel transit time increasing completion rates from 76 to 97
The proposal is to perform a randomised controlled study using Citramag and Senna bowel preparation or Metoclopramide to determine whether test completion rates are improved and whether the images of the bowel are of better quality
The hypothesis is that the improved wall visibility and increased completion rates will improve the diagnostic yield of Capsule endoscopy and therefore improve patient care
So far no optimal protocol for bowel preparation prior to Capsule endoscopy has been established Recently several studies have shown that bowel preparation with polyethylene glycol significantly reduces both gastric and small bowel transit times Similarly visualization of the small intestine and therefore diagnostic yield have both been shown to be improved by both sodium phosphate and polyethylene glycol preparation A more recent study by Selby et al also demonstrates that the prokinetic agent metoclopramide which is known to promote emptying of the stomach reduced both stomach and small bowel transit time increasing completion rates from 76 to 97
The proposal is to perform a randomised controlled study using Citramag and Senna bowel preparation or Metoclopramide to determine whether test completion rates are improved and whether the images of the bowel are of better quality
The hypothesis is that the improved wall visibility and increased completion rates will improve the diagnostic yield of Capsule endoscopy and therefore improve patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT No 2005-004423-19 | None | None | None |
| REC 05Q040594 | None | None | None |