Bowel Preparation and Prokinetics in Capsule Endoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00275184
First received: January 10, 2006
Last updated: September 21, 2007
Last verified: September 2007
  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

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel

Secondary Outcome Measures:
  • The tolerance of the bowel preparation to indicate future usage

Estimated Enrollment: 150
Study Start Date: January 2006
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275184

Contacts
Contact: Christopher Fraser, MB BCH, MD, FRCP chris.fraser@imperial.ac.uk
Contact: Neil Patterson, MB BCH, MD, MRCP neil@rnpaterson.idps.co.uk

Locations
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         
Sponsors and Collaborators
North West London Hospitals NHS Trust
Investigators
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, Refractory
Gastrointestinal Hemorrhage
Hemorrhage
Intestinal Diseases
Anemia
Bone Marrow Diseases
Digestive System Diseases
Gastrointestinal Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Pathologic Processes
Magnesium citrate
Metoclopramide
Antiemetics
Autonomic Agents
Cathartics
Central Nervous System Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014