Bowel Preparation and Prokinetics in Capsule Endoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00275184|
Recruitment Status : Unknown
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was: Recruiting
First Posted : January 11, 2006
Last Update Posted : September 24, 2007
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 or disease||Intervention/treatment||Phase|
|Small Bowel Disease Gastrointestinal Hemorrhage Refractory Anemia||Drug: Senna Drug: Citramag powder Drug: Metoclopramide||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide|
|Study Start Date :||January 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275184
|Contact: Christopher Fraser, MB BCH, MD, FRCPfirstname.lastname@example.org|
|Contact: Neil Patterson, MB BCH, MD, MRCPemail@example.com|
|St Mark's Hospital, North West London Hospitals NHS Trust||Recruiting|
|London, United Kingdom, HA1 3UJ|
|Contact: Alan Warnes, PhD firstname.lastname@example.org|
|Contact: Iva Hauptmannova, BSc, MA email@example.com|
|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|