Bowel Preparation and Prokinetics in Capsule Endoscopy

Gastrointestinal Hemorrhage Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Refractory Anemia
• Small Bowel Disease

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