Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Interventions
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Senna
Citramag powder
Metoclopramide
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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London North West Healthcare NHS Trust
OTHER
Principal Investigators
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Christopher Fraser, MB BCH, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
St Mark's Hospital, North West London Hospitals NHS Trust
Locations
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St Mark's Hospital, North West London Hospitals NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Alan Warnes, PhD
Role: primary
Iva Hauptmannova, BSc, MA
Role: backup
Other Identifiers
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REC 05/Q0405/94
Identifier Type: -
Identifier Source: secondary_id
EudraCT No: 2005-004423-19
Identifier Type: -
Identifier Source: secondary_id
05/CE/94
Identifier Type: -
Identifier Source: org_study_id