Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001131246
Ethics application status
Approved
Date submitted
29/05/2018
Date registered
10/07/2018
Date last updated
21/10/2021
Date data sharing statement initially provided
9/05/2019
Date results information initially provided
21/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study of the feasibility of capsule colonoscopy in Crohn’s Disease and its correlation with conventional colonoscopy and Faecal Calprotectin.
Scientific title
A prospective study of the feasibility of capsule colonoscopy in Crohn’s Disease and its correlation with conventional colonoscopy and Faecal Calprotectin.
Secondary ID [1] 287909 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 296786 0
Condition category
Condition code
Oral and Gastrointestinal 297020 297020 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following investigations will be performed on participants: 1. capsule colonoscopy, 2. conventional colonoscopy and 3. faecal calprotectin (stool sample). The day before the procedure, patients will be asked to ingest bowel prep as per standard regime. Patients will be asked to come in early to clinic and have extra bowel prep before patient swallows a small capsule (pillcam colon) which will take photos of their colon. They will need to wear a small device around their hip for the duration of the day which captures the photos. It is best to wear lose fitting clothing. The participants conventional colonoscopy will be booked for the same day, last on the list to make sure there is adequate time for the pillcam colon to take photos. The pill cam colon will be administered by a nurse. The conventional colonoscopy will be conducted by a Gastroenterologist and usually takes approximately 20 minutes. The stool sample will be need before the colonoscopy. The patient can complete one at home and bring it with them on the day of the procedure. The whole study takes around 24 hours.

Intervention code [1] 301365 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296618 0
Quality of colonoscopy as assessed by blinded review of procedure recording by independent panel of 3 gastroenterologists
Timepoint [1] 296618 0
Assessed approximately within a 1 month of the colonoscopy.
Secondary outcome [1] 318938 0
Faecal calprotectin as assessed by laboratory ELISA of stool sample
Timepoint [1] 318938 0
After the colonoscopy
Secondary outcome [2] 348887 0
Mucosal Healing. Mucosal healing will be assessed using the Simple Endoscopic Score for Crohn's Disease (SES- CD).
Timepoint [2] 348887 0
After the colonoscopy

Eligibility
Key inclusion criteria
Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease aged 18-75 years
Gender: both male and female
Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes:
a) Patients who have had Anti TNF induction therapy 6-12 months prior to commencement of this study.
b) Patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients must not:
Have known/suspected gastrointestinal obstruction
Have swallowing disorder
Have a known oesophageal stricture
Have severe gastroparesis
Have dementia
Have a cardiac pacemaker or other implanted medical device
Have sever cardiac or renal insufficiency
Have a previous allergy or contraindication to bowel preparation
Be pregnant
Prior major abdominal surgery
Colonoscopy is contraindicated

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/02/2015
Date of last participant enrolment
Anticipated
Actual
7/06/2019
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
64
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11012 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 22803 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 299613 0
Commercial sector/Industry
Name [1] 299613 0
Covidien/Medtronic
Country [1] 299613 0
United States of America
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 298935 0
None
Name [1] 298935 0
Address [1] 298935 0
Country [1] 298935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300516 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300516 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 300516 0
Australia
Date submitted for ethics approval [1] 300516 0
Approval date [1] 300516 0
01/02/2015
Ethics approval number [1] 300516 0
2014.214

Summary
Brief summary
To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).
To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing.
To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy.
To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy.

Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy after undergoing bowel preparation.

The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day.

Recorded images will be assessed once the images have been deidentified. Assessment will include the level of mucosal disease. To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD).

The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61578 0
Prof Finlay Macrae
Address 61578 0
Colorectal Medicine & Genetics
Level 3 Centre, Main Building
300 Grattan Street
The Royal Melbourne Hospital Parkville Victoria 3050
Country 61578 0
Australia
Phone 61578 0
+61393427580
Fax 61578 0
+61393427848
Email 61578 0
[email protected]
Contact person for public queries
Name 61579 0
Prof Finlay Macrae
Address 61579 0
Colorectal Medicine & Genetics
Level 3 Centre, Main Building
300 Grattan Street
The Royal Melbourne Hospital Parkville Victoria 3050
Country 61579 0
Australia
Phone 61579 0
+61393427580
Fax 61579 0
+61393427848
Email 61579 0
[email protected]
Contact person for scientific queries
Name 61580 0
Prof Finlay Macrae
Address 61580 0
Colorectal Medicine & Genetics
Level 3 Centre, Main Building
300 Grattan Street
The Royal Melbourne Hospital Parkville Victoria 3050
Country 61580 0
Australia
Phone 61580 0
+61393427580
Fax 61580 0
+61393427848
Email 61580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not planned that IPD sharing will be available publically for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.