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Trial registered on ANZCTR


Registration number
ACTRN12616000636459
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
17/05/2016
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Capsule Endoscopy in Acute Upper Gastrointestinal Bleeding.
Scientific title
A prospective randomised control trial of Early Capsule Endoscopy in patients with Acute Upper Gastrointestinal Bleeding.
Secondary ID [1] 289208 0
Nil known
Universal Trial Number (UTN)
U1111-1182-8556
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute upper gastrointestinal bleeding 298764 0
Condition category
Condition code
Oral and Gastrointestinal 298814 298814 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research involves procedures and clinical care which are performed as standard practice currently. Patients with a negative gastroscopy will be randomised to either the control group and receive a Colonoscopy, or the intervention group and receive a Capsule Endoscopy as their second investigation.
Those patients randomised to the Capsule Endoscopy group will be orally administered a single disposable endoscopy capsule which will pass through the gastrointestinal tract taking continuous images that will be sent to a data receiver, This data will be downloaed and interpreted by a trained gastroenterologist. This will all be completed during athe same inpatient hospital admission.
Intervention code [1] 294742 0
Diagnosis / Prognosis
Comparator / control treatment
Patients in the control group will be randomised to receive a colonoscopy following a negative gastroscopy, which is part of current standard clinical practice. A consultant gastroenterologist will perform the procedure of approximately 30 minutes duration, with anaesthesia provided by a consultant anaesthetist.
Control group
Active

Outcomes
Primary outcome [1] 298286 0
The primary outcome will be the proportion of patients in whom a source of bleeding is identified on capsule endoscopy or colonoscopy.
Timepoint [1] 298286 0
The primary timepoint will be 1 day after the colonoscopy or capsule endoscopy.
Secondary outcome [1] 323750 0
A secondary outcome will be number of blood transfusions received by a patient which will be determined through review of their electronic medical records.
Timepoint [1] 323750 0
3 months after initial presentation
Secondary outcome [2] 323751 0
A secondary outcome will be length of hospital stay which will be determined through review of electronic medical records.
Timepoint [2] 323751 0
3 months after initial presentation
Secondary outcome [3] 323752 0
A secndary outcome will be number of hospital representations which will be determined through review of the electronic medical records.
Timepoint [3] 323752 0
3 months after initial presentation

Eligibility
Key inclusion criteria
Participants will be males or females who present with acute melaena and/or haematemesis and have a negative gastroscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients less than 18 years of age and pregnant females will be excluded form this study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2016
Actual
1/05/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5794 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 13237 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 293583 0
Hospital
Name [1] 293583 0
Gold Coast University Hospital
Country [1] 293583 0
Australia
Primary sponsor type
Government body
Name
QLD Health
Address
Gold Coast University Hospital
1 Hospital Blvd
Southport, 4215, QLD
Country
Australia
Secondary sponsor category [1] 292405 0
None
Name [1] 292405 0
Address [1] 292405 0
Country [1] 292405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295031 0
Gold Coast Hospital and Health Services Human Research Ethics Committee
Ethics committee address [1] 295031 0
Gold Coast University Hospital
1 Hospital Blvd, Southport, QLD, 4215
Ethics committee country [1] 295031 0
Australia
Date submitted for ethics approval [1] 295031 0
11/05/2016
Approval date [1] 295031 0
07/07/2016
Ethics approval number [1] 295031 0

Summary
Brief summary
All patients with upper gastrointestinal bleeding (UGIB) undergo a gastroscopy urgently. However, in a significant proportion of these patients a source is not identified. Small bowel bleeding is highly likely to be the source in a large number of these patients. This may be identified by capsule endoscopy. Proximal colonic bleeding is also likely in patients with melaena and is identifiable by colonoscopy.
As per current standard practice, patients will undergo a colonoscopy frequently or a capsule endoscopy (CE) less often, in an attempt to find the cause of bleeding. Capsule endoscopy is noninvasive, better tolerated and preferred by patients as bowel prep and anaesthesia are not required. However,it is uncertain who will benefit most by having a capsule endoscopy as the second test.
The focus of our study is to look at the subgroup of patients who will benefit most by having early Capsule Endoscopy in this context. The study aims to compare two groups of patients, one having capsule endoscopy VS the other having colonoscopy as the second test following a negative gastroscopy to determine differences in ability to detect bleeding source and therefore change patient outcome.
All patients with UGIB with a negative gastroscopy will be considered for the study.
This is a prospective randomised control trial. Primary endpoint measured will be identification of the source of bleeding. Secondary endpoints measured will be reduced blood transfusions, reduced length of stay, reduced number of investigations and reduced hospital admissions.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 880 880 0 0
/AnzctrAttachments/370693-Research Protocol - Early Capsule Endoscopy.docx

Contacts
Principal investigator
Name 65830 0
Dr Tegan Stevenson
Address 65830 0
Gold Coast University Hospital,
1 Hospital Blvd
Southport, QLD, 4215
Country 65830 0
Australia
Phone 65830 0
+61405736406
Fax 65830 0
Email 65830 0
[email protected]
Contact person for public queries
Name 65831 0
Tegan Stevenson
Address 65831 0
Gold Coast University Hospital,
1 Hospital Blvd
Southport, QLD, 4215
Country 65831 0
Australia
Phone 65831 0
+61405736406
Fax 65831 0
Email 65831 0
[email protected]
Contact person for scientific queries
Name 65832 0
Tegan Stevenson
Address 65832 0
Gold Coast University Hospital,
1 Hospital Blvd
Southport, QLD, 4215
Country 65832 0
Australia
Phone 65832 0
+61405736406
Fax 65832 0
Email 65832 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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