Bowel Preparation and Prokinetics in Capsule Endoscopy

Sponsor

London North West Healthcare NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT00275184

Collaborator

(none)

150

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Bowel Disease Gastrointestinal Hemorrhage Refractory Anemia	Drug: Senna Drug: Citramag powder Drug: Metoclopramide	Phase 3

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

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel []

Secondary Outcome Measures

The tolerance of the bowel preparation to indicate future usage []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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