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Bowel Preparation and Prokinetics in Capsule Endoscopy

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ClinicalTrials.gov Identifier: NCT00275184
Recruitment Status : Unknown
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was:  Recruiting
First Posted : January 11, 2006
Last Update Posted : September 24, 2007
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : January 2006


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. The tolerance of the bowel preparation to indicate future usage

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275184


Contacts
Contact: Christopher Fraser, MB BCH, MD, FRCP chris.fraser@imperial.ac.uk
Contact: Neil Patterson, MB BCH, MD, MRCP neil@rnpaterson.idps.co.uk

Locations
United Kingdom
St Mark's Hospital, North West London Hospitals NHS Trust Recruiting
London, United Kingdom, HA1 3UJ
Contact: Alan Warnes, PhD       alan.warnes@nwlh.nhs.ul   
Contact: Iva Hauptmannova, BSc, MA       iva.hauptmannova@nwlh.nhs.uk   
Sub-Investigator: Neil Patterson, MB BCH, MD, MRCP         
Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
Principal Investigator: Christopher Fraser, MB BCH, MD, FRCP St Mark's Hospital, North West London Hospitals NHS Trust
More Information

ClinicalTrials.gov Identifier: NCT00275184     History of Changes
Other Study ID Numbers: 05/CE/94
REC 05/Q0405/94
EudraCT No: 2005-004423-19
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by London North West Healthcare NHS Trust:
Bowel preparation
capsule endoscopy
randomised
Citramag
Senna
Metoclopramide
Patients referred for Capsule endoscopy
occult/overt gastrointestinal bleeding
other suspected small bowel pathology

Additional relevant MeSH terms:
Hemorrhage
Anemia, Refractory
Gastrointestinal Hemorrhage
Pathologic Processes
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metoclopramide
Magnesium citrate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cathartics