A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 who have been referred for capsule endoscopy
Exclusion Criteria
- •Known or suspected gastrointestinal tract obstruction as this may impede passage of the capsule
- •Known small bowel stricture or fistula as this may impede capsule passage
- •Pregnancy, breast feeding or phaeochromocytoma as metoclopramide is contraindicated
- •Recent gastrointestinal surgery in view of the risk of impeded capsule passage
- •Permanent cardiac pacemaker or implantable defibrillator in-situ to avoid the risk of possible interference
- •Congestive cardiac failure as citramag is contraindicated in such patients
Outcomes
Primary Outcomes
Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
Secondary Outcomes
- The tolerance of the bowel preparation to indicate future usage