Differences in Preparation for Small Bowel Capsule Endoscopy
Primary Purpose
Capsule Endoscopy, Inflammatory Bowel Diseases, Celiac Disease
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Klean Prep
Clear liquids only
Sponsored by
About this trial
This is an interventional other trial for Capsule Endoscopy
Eligibility Criteria
Inclusion Criteria:
- Adult outpatients (18 years or older)
- routinely referred for small bowel video capsule endoscopy (CE)
Exclusion Criteria:
- dysphagia
- severe gastroparesis requiring endoscopic placement of capsule
- small bowel obstruction
- pregnancy
Sites / Locations
- Hotel Dieu HospitalRecruiting
- Royal Hallamshire HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Bowel Prep routine
Bowel Prep Split
No bowel prep
Arm Description
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
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
Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure
Outcomes
Primary Outcome Measures
Clinician assessed Visual Quality of small bowel
Visual quality of the small bowel during capsule endoscopy as assessed by a clinician
clinician assessed Diagnostic yield during capsule endoscopy
Ability to produce a diagnosis following capsule endoscopy as assessed by a clinician
Secondary Outcome Measures
Full Information
NCT ID
NCT03351972
First Posted
November 17, 2017
Last Updated
October 20, 2020
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Hotel Dieu Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03351972
Brief Title
Differences in Preparation for Small Bowel Capsule Endoscopy
Official Title
Does Bowel Preparation (Either as a Single or Divided Dose) Produce Better Cleansing and Diagnostic Yield Than no Preparation at All in Small Bowel Capsule Endoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Hotel Dieu Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The introduction of video capsule endoscopy in 2000 has provided a convenient and minimally invasive imaging method for the whole small bowel. Capsule Endoscopy is used to investigate a number of conditions such as obscure gastrointestinal bleeding, iron deficiency anaemia, inflammatory bowel disease, celiac disease, small bowel tumors, and hereditary polyposis syndromes. However, Capsule Endoscopy capsules are not able to suction fluid or wash the intestine, thus making it susceptible to decreased visualization quality and diagnostic yield due to dark intestinal contents or air bubbles. In order to determine the best method for bowel preparation before Capsule Endoscopy, this study seeks to determine in patients undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the aggregate of all the active preparation groups compared to than clear fluids only group. Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel examination by time) and small bowel transit time (measured as time from first duodenal image to first cecal image). Adult outpatients referred for small bowel video capsule endoscopy will be considered for the study and this will run in the clinical environment as per routine. Patients will have been referred for capsule endoscopy as per normal clinical practice so not additional procedure will take place. Patients will be randomly assigned to in a one to one fashion to one of three groups in order to explore whether bowel preparation (either as a single or divided dose) produce better cleansing and diagnostic yield than no preparation at all in small bowel capsule endoscopy.
Detailed Description
In order to determine the best method for bowel preparation before Capsule Endoscopy, this study seeks to determine in patients undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the aggregate of all the active preparation groups compared to than clear fluids only group. Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel examination by time) and small bowel transit time (measured as time from first duodenal image to first cecal image).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Capsule Endoscopy, Inflammatory Bowel Diseases, Celiac Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bowel Prep routine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bowel Prep Split
Arm Type
Active Comparator
Arm Description
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
Arm Title
No bowel prep
Arm Type
Experimental
Arm Description
Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure
Intervention Type
Drug
Intervention Name(s)
Klean Prep
Other Intervention Name(s)
Polyethylene Glycol
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Clear liquids only
Intervention Description
Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure
Primary Outcome Measure Information:
Title
Clinician assessed Visual Quality of small bowel
Description
Visual quality of the small bowel during capsule endoscopy as assessed by a clinician
Time Frame
1 day
Title
clinician assessed Diagnostic yield during capsule endoscopy
Description
Ability to produce a diagnosis following capsule endoscopy as assessed by a clinician
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult outpatients (18 years or older)
routinely referred for small bowel video capsule endoscopy (CE)
Exclusion Criteria:
dysphagia
severe gastroparesis requiring endoscopic placement of capsule
small bowel obstruction
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark McAlindon, MD
Phone
0114 2711899
Email
Mark.McAlindon@sth.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Barron, Mr
Phone
0114 2711899
Email
Luke.Barron@sth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark McAlindon, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston,
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Hookey, MD
Email
hookeyl@hdh.kari.net
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Barron, MSc
Phone
0114 2711899
Email
luke.barron@sth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Mark McAlindon, MD
First Name & Middle Initial & Last Name & Degree
Laurence Hookey, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study has been set-up and designed to ensure no IPD is shared
Learn more about this trial
Differences in Preparation for Small Bowel Capsule Endoscopy
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