Bowel Preparation and Prokinetics in Capsule Endoscopy
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide |
- Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
- The tolerance of the bowel preparation to indicate future usage
| 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:
- 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| 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00275184 History of Changes |
| Other 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 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by North West London Hospitals 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:
|
Anemia Anemia, Refractory Gastrointestinal Hemorrhage Hemorrhage Intestinal Diseases Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Metoclopramide Magnesium citrate |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cathartics |
ClinicalTrials.gov processed this record on June 18, 2013