Gastrointestinal Hemorrhage Clinical Trial
Official title:
A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Mark's Hospital, North West London Hospitals NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
London North West Healthcare NHS Trust |
United Kingdom,
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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