Bowel Preparation and Prokinetics in Capsule Endoscopy

Condition(s) targeted: Small Bowel Disease; Gastrointestinal Hemorrhage; Refractory Anemia

Intervention: Senna (Drug); Citramag powder (Drug); Metoclopramide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: North West London Hospitals NHS Trust

Official(s) and/or principal investigator(s):
Christopher Fraser, MB BCH, MD, FRCP, Principal Investigator, Affiliation: St Mark's Hospital, North West London Hospitals NHS Trust

Overall contact:
Christopher Fraser, MB BCH, MD, FRCP, Email: chris.fraser@imperial.ac.uk

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.

Official title: A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide

Study design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel

Secondary outcome: The tolerance of the bowel preparation to indicate future usage

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Christopher Fraser, MB BCH, MD, FRCP, Email: chris.fraser@imperial.ac.uk

St Mark's Hospital, North West London Hospitals NHS Trust, London HA1 3UJ, United Kingdom; Recruiting
Alan Warnes, PhD, Email: alan.warnes@nwlh.nhs.ul
Iva Hauptmannova, BSc, MA, Email: iva.hauptmannova@nwlh.nhs.uk
Neil Patterson, MB BCH, MD, MRCP, Sub-Investigator

North West London Hospitals NHS Trust web includes links to St Mark's

Starting date: January 2006
Last updated: September 21, 2007