Clinical Trial: Bowel Preparation and Prokinetics in Capsule Endoscopy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
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.
Detailed Summary:
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.
Sponsor: London North West Healthcare NHS Trust
Current Primary Outcome: Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
Original Primary Outcome: Same as current
Current Secondary Outcome: The tolerance of the bowel preparation to indicate future usage
Original Secondary Outcome: The tolerance of the bowel preparation to indicate future usage.
Information By: London North West Healthcare NHS Trust
Dates:
Date Received: January 10, 2006
Date Started: January 2006
Date Completion:
Last Updated: September 21, 2007
Last Verified: September 2007
