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| Sponsor: | North West London Hospitals NHS Trust |
|---|---|
| Information provided by: | North West London Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00275184 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Small Bowel Disease Gastrointestinal Hemorrhage Refractory Anemia |
Drug: Senna Drug: Citramag powder Drug: Metoclopramide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher Fraser, MB BCH, MD, FRCP | chris.fraser@imperial.ac.uk | |
| Contact: Neil Patterson, MB BCH, MD, MRCP | neil@rnpaterson.idps.co.uk |
| 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 | |
| Principal Investigator: | Christopher Fraser, MB BCH, MD, FRCP | St Mark's Hospital, North West London Hospitals NHS Trust |
More Information
| Study ID Numbers: | 05/CE/94, REC 05/Q0405/94, EudraCT No: 2005-004423-19 |
| Study First Received: | January 10, 2006 |
| Last Updated: | September 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00275184 History of Changes |
| Health Authority: | United Kingdom: National Health Service; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Bowel preparation capsule endoscopy randomised Citramag Senna |
Metoclopramide Patients referred for Capsule endoscopy occult/overt gastrointestinal bleeding other suspected small bowel pathology |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Antiemetics Cathartics Hemorrhage Metoclopramide Pathologic Processes Anemia, Refractory Therapeutic Uses Magnesium citrate Hematologic Diseases |
Myelodysplastic Syndromes Anemia Gastrointestinal Hemorrhage Gastrointestinal Agents Dopamine Antagonists Intestinal Diseases Pharmacologic Actions Digestive System Diseases Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Bone Marrow Diseases Central Nervous System Agents |