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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00275184
Other study ID # 05/CE/94
Secondary ID REC 05/Q0405/94E
Status Recruiting
Phase Phase 3
First received January 10, 2006
Last updated September 21, 2007
Start date January 2006

Study information

Verified date September 2007
Source London North West Healthcare NHS Trust
Contact Christopher Fraser, MB BCH, MD, FRCP
Email chris.fraser@imperial.ac.uk
Is FDA regulated No
Health authority United Kingdom: National Health ServiceUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic


Intervention

Drug:
Senna

Citramag powder

Metoclopramide


Locations

Country Name City State
United Kingdom St Mark's Hospital, North West London Hospitals NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
Secondary The tolerance of the bowel preparation to indicate future usage
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