Investigation of suspected small bowel disease by Capsule Endoscopy
Conditions
Interventions
Trade Name: Citramag
Pharmaceutical Form: Powder for oral solution
Trade Name: Metoclopramide
Pharmaceutical Form: Tablet
Trade Name:
Sponsors
The North West London Hospitals NHS Trust, Northwick Park Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have been referred for Capsule Endoscopy to St Mark's Hospital for suspected small bowel disease and be aged over 18 years old. Consecutive patients from the start date of the study will be recruited who fulfill the criteria and who are willing to take part. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age < 18 years, known or suspected gastrointestinal tract obstruction, known small bowel stricture or fistula, pregnancy, permanent cardiac pacemaker or implantable defibrillator in-situ congestive cardiac failure previous adverse reaction to Metoclopramide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether bowel preparation with Citramag and Senna, or the use of a prokinetic agent (Metoclopramide) improves the quality of Capsule endoscopy images and reduces gastrointestinal time, thereby improving the detection rate of small bowel lesions, and increase the completion rate of capsule studies.; Primary end point(s): i.Image quality Image quality will be assessed on a 4 point scale as described by Dai et al (2), graded as: 1, large volume of residual ingested material; 2, moderate volume of residual ingested food; 3, small volume of residual ingested food; 4, clear or coloured liquid. It was further assessed as the percentage of visualized bowel as determined during 5 minute video segments at 1 hour intervals after passage through the pylorus; 1, less than 25%; 2, 25-49%; 3, 50-75%; 4, greater than 75%. ii.Small bowel and gastric transit times Small bowel transit time will be taken from first duodenal image until the capsule enters the caecum or until the battery is depleted. Gastric transit will be calculated from the time of entry to the stomach until passage through the pylorus. iii.Completion rate Small bowel examination will be considered complete if the capsule passes into the caecum. ;Secondary Objective: Secondary objectives will be to determine whether patients could routinely tolerate this bowel preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy is improved. | — |
Countries
United Kingdom
Outcome results
None listed