Differences in Preparation for Small Bowel Capsule Endoscopy
NCT ID: NCT03351972
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
230 participants
INTERVENTIONAL
2017-11-23
2021-12-01
Brief Summary
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Detailed Description
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Group Assignment:
The groups will have some common instructions: all groups will be instructed to stop iron supplements five days prior to the exam. On the day prior to the exam, patients will be instructed to have a light breakfast and lunch, followed by only clear fluids. Over the day, patients will be encouraged to have at least two litres of clear fluids. On the day of the exam, 80 mg of oral simethicone will be given 10 minutes prior to the exam. The capsule will be ingested at 9:00am, after which fluids may be consumed 2 hours later, and solid food 4 hours later. Patients will be randomly assigned to in a one to one fashion to one of three groups using a central online randomization program. The groups for this project include:
A. Control: no additional instructions beyond those above will be given. B. Single dose Polyethylene Glycol: Patients will take 2 litre of Polyethylene Glycol at 6am the day of the exam.
C. Split dose Polyethylene Glycol: Patients will take 1 litre of Polyethylene Glycol at 7pm the evening prior to the exam and 1 litre at 6am the day of the exam.
Recruitment of patients will be performed from outpatient gastroenterology clinics at Sheffield Teaching Hospitals NHS Trust. After a request for Capsule Endoscopy from a referring physician, the patient will be contacted by telephone by one of the Capsule endoscopy nurse specialists (who are also involved in the study) as per normal practice. The study will be discussed, the procedure explained and a convenient date for the procedure will be agreed with the patient. The patient will be invited to meet with one of the research staff at a mutually agreed time in order to go through the study once more and provide written consent should they agree to participate. Should they wish to participate but would prefer to complete a postal consent form, this will be arranged. The procedure will be completed according to normal practice. Patients will be advised that they can withdraw from the study at any point and choose a preferred option for bowel preparation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Bowel Prep routine
Participants randomised to this arm will receive their bowel prep (Klean Prep) with the routine guidance of taking the contents the day before their capsule endoscopy
Klean Prep
Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure
Bowel Prep Split
Participants randomised to this arm will receive their bowel prep (Klean Prep) with the guidance stating to take the first dose the day before the capsule endoscopy and the second dose the morning of the capsule endoscopy
Klean Prep
Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure
No bowel prep
Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure
Clear liquids only
Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure
Interventions
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Klean Prep
Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure
Clear liquids only
Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* routinely referred for small bowel video capsule endoscopy (CE)
Exclusion Criteria
* severe gastroparesis requiring endoscopic placement of capsule
* small bowel obstruction
* pregnancy
18 Years
ALL
No
Sponsors
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Hotel Dieu Hospital
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Mark McAlindon, MD
Role: PRINCIPAL_INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Locations
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Hotel Dieu Hospital
Kingston, Ontario, Canada
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STH20061
Identifier Type: -
Identifier Source: org_study_id
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