Patients Attending Hospital for Small Bowel Endoscopy Clinical Trial
Official title:
Randomised Comparison of a Standard Protocol Using Metoclopramide Versus a Hand Held Magnet to Enhance Gastric Emptying of the Small Bowel Capsule.
Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected
diseases of the small bowel. The procedure is safe and noninvasive, the main risk being
capsule retention occurring in approximately 2% of procedures. Other problems such as
incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric
emptying, slow small bowel transit, faulty equipment and poor bowel preparation.
Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime'
viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an
intramuscular prokinetic injection if this fails. This approach has disadvantages since an
intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly
used for this purpose, has a risk of acute dystonic reactions particularly in young
patients.
Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the
capsule in the upper GI tract. We propose that this could be used, alongside positional
changes, to expedite capsule transit through the stomach thus improving completion rates and
avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled
study comparing a standard protocol for small bowel capsule endoscopy against a hand held
magnet and positional change protocol to enhance gastric emptying of the wireless capsule.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic