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| ID | Type | Description | Link |
|---|---|---|---|
| REC 05/Q0405/94 | |||
| EudraCT No: 2005-004423-19 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senna | Drug | |||
| Citramag powder | Drug | |||
| Metoclopramide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel |
| Measure | Description | Time Frame |
|---|---|---|
| The tolerance of the bowel preparation to indicate future usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Fraser, MB BCH, MD, FRCP | Contact | chris.fraser@imperial.ac.uk | ||
| Neil Patterson, MB BCH, MD, MRCP | Contact | neil@rnpaterson.idps.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Fraser, MB BCH, MD, FRCP | St Mark's Hospital, North West London Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mark's Hospital, North West London Hospitals NHS Trust | Recruiting | London | HA1 3UJ | United Kingdom |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D000753 | Anemia, Refractory |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000081226 | Sennosides |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |