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Bowel Preparation and Prokinetics in Capsule Endoscopy

Primary Purpose

Small Bowel Disease, Gastrointestinal Hemorrhage, Refractory Anemia

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Senna
Citramag powder
Metoclopramide
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Small Bowel Disease focused on measuring Bowel preparation, capsule endoscopy, randomised, Citramag, Senna, Metoclopramide, Patients referred for Capsule endoscopy, occult/overt gastrointestinal bleeding, other suspected small bowel pathology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Mark's Hospital, North West London Hospitals NHS TrustRecruiting

Outcomes

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

Full Information

First Posted
January 10, 2006
Last Updated
September 21, 2007
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00275184
Brief Title
Bowel Preparation and Prokinetics in Capsule Endoscopy
Official Title
A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Disease, Gastrointestinal Hemorrhage, Refractory Anemia
Keywords
Bowel preparation, capsule endoscopy, randomised, Citramag, Senna, Metoclopramide, Patients referred for Capsule endoscopy, occult/overt gastrointestinal bleeding, other suspected small bowel pathology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Senna
Intervention Type
Drug
Intervention Name(s)
Citramag powder
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Primary Outcome Measure Information:
Title
Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
Secondary Outcome Measure Information:
Title
The tolerance of the bowel preparation to indicate future usage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Fraser, MB BCH, MD, FRCP
Email
chris.fraser@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Patterson, MB BCH, MD, MRCP
Email
neil@rnpaterson.idps.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Fraser, MB BCH, MD, FRCP
Organizational Affiliation
St Mark's Hospital, North West London Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mark's Hospital, North West London Hospitals NHS Trust
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Warnes, PhD
Email
alan.warnes@nwlh.nhs.ul
First Name & Middle Initial & Last Name & Degree
Iva Hauptmannova, BSc, MA
Email
iva.hauptmannova@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Neil Patterson, MB BCH, MD, MRCP

12. IPD Sharing Statement

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Bowel Preparation and Prokinetics in Capsule Endoscopy

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