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Differences in Preparation for Small Bowel Capsule Endoscopy

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ClinicalTrials.gov Identifier: NCT03351972
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Hotel Dieu Hospital
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Inflammatory Bowel Diseases Celiac Disease Drug: Klean Prep Other: Clear liquids only Phase 4

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: 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
Other Name: Polyethylene Glycol
Active Comparator: 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
 Drug: 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
Other Name: Polyethylene Glycol
Experimental: No bowel prep
Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure
 Other: Clear liquids only
Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure


Outcome Measures
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Primary Outcome Measures :
  1. Clinician assessed Visual Quality of small bowel [ Time Frame: 1 day ]
    Visual quality of the small bowel during capsule endoscopy as assessed by a clinician

  2. clinician assessed Diagnostic yield during capsule endoscopy [ Time Frame: 1 day ]
    Ability to produce a diagnosis following capsule endoscopy as assessed by a clinician


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT03351972


Contacts
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Contact: Mark McAlindon, MD 0114 2711899 Mark.McAlindon@sth.nhs.uk
Contact: Luke Barron, Mr 0114 2711899 Luke.Barron@sth.nhs.uk

Locations
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Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston,, Ontario, Canada
Contact: Laurence Hookey, MD       hookeyl@hdh.kari.net   
United Kingdom
Royal Hallamshire Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Luke Barron, MSc    0114 2711899    luke.barron@sth.nhs.uk   
Principal Investigator: Mark McAlindon, MD         
Principal Investigator: Laurence Hookey, MD         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Hotel Dieu Hospital
Investigators
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Principal Investigator: Mark McAlindon, MD Sheffield Teaching Hospitals NHS Foundation Trust
More Information
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03351972    
Other Study ID Numbers: STH20061
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study has been set-up and designed to ensure no IPD is shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Celiac Disease
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Gastroenteritis
Malabsorption Syndromes
Metabolic Diseases