Clinical trial NCT00275184: Bowel Preparation and Prokinetics in Capsule Endoscopy
Official title: A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small Bowel Disease
Gastrointestinal Hemorrhage
Refractory Anemia
Keywords: Bowel preparation
capsule endoscopy
randomised
Citramag
Senna
Metoclopramide
Patients referred for Capsule endoscopy
occult/overt gastrointestinal bleeding
other suspected small bowel pathology
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2006-01-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 who have been referred for capsule endoscopy

Exclusion Criteria:

* Under 18
* 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

Primary outcomes:
measure: Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
Secondary outcomes:
measure: The tolerance of the bowel preparation to indicate future usage
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mark's Hospital, North West London Hospitals NHS Trust
Study officials:
affiliation: St Mark's Hospital, North West London Hospitals NHS Trust
name: Christopher Fraser, MB BCH, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: