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Trial registered on ANZCTR


Registration number
ACTRN12617000530325
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
11/04/2017
Date last updated
14/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of dynamic clot formation in Endoscopic Mucosal Resection
Scientific title
Evaluation of dynamic clot formation in Endoscopic Mucosal Resection
Secondary ID [1] 291631 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sessile polyp 302753 0
bleeding 302754 0
hyperfibrinolysis 302755 0
Condition category
Condition code
Oral and Gastrointestinal 302271 302271 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 302272 302272 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Blood 302295 302295 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In theory electro surgery can increase plasminogen activity and cause hyperfibrinolysis..
viscoelastic testing on 3 occasions, which is not part of standard care, might confirm this hypothesis which has not been previously demonstrated in humans.
Viscoelastic testing is assessing whole blood clotting. At our hospital this is done by Thrombelastomerty with ROTEM by our Pathology provider. Only 4 ml of blood is required and the test can be done for up to 4 hours after the sample is taken.
Intervention code [1] 297718 0
Early detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301681 0
coagulation abnormality detected by Thrombelastometry
Timepoint [1] 301681 0
post procedural , before discharge from hospital within 2 hours of EMR, and on day two post EMR
Secondary outcome [1] 333549 0
bleeding, noted by patient, prompting contacting the hospital and/or re-admission
Timepoint [1] 333549 0
2-3 days post procedure

Eligibility
Key inclusion criteria
patients undergoing EMR for large sessile colonic polyps
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on anticoagulants or antiplatelet agents

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Analysis will be descriptive

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7776 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 15709 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 296132 0
Hospital
Name [1] 296132 0
Anaesthesia research fund
Address [1] 296132 0
Haydown Rd
Elizabeth Vale
SA 5112
Country [1] 296132 0
Australia
Funding source category [2] 296940 0
Government body
Name [2] 296940 0
South Australian PBM council
Address [2] 296940 0
11 Hindmarsh Square, Adelaide, SA 5000
Mail: PO Box 287, Rundle Mall, Adelaide SA 5001
Country [2] 296940 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin
Address
Haydown Rd
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 295028 0
None
Name [1] 295028 0
Address [1] 295028 0
Country [1] 295028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297377 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 297377 0
Basil Hetzel Institute
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 297377 0
Australia
Date submitted for ethics approval [1] 297377 0
27/03/2017
Approval date [1] 297377 0
07/04/2017
Ethics approval number [1] 297377 0
HREC/17/TQEH/66

Summary
Brief summary
Approximately 17000 colonic cancers are diagnosed in Australia each year. The majority of patients will undergo surgery. Large sessile lesions are traditionally removed surgically. In recent years advances in Endoscopic Mucosal Resection (EMR) emerged as a safe, effective, minimally invasive technique for removal of large sessile polyps and can be performed as an ambulatory procedure in special Gastroenterology units. This has potentially a much smaller impact on the patient and allows a faster recovery.
However, one of the main risk factors of EMR is delayed bleeding. Clinically significant post-endoscopic bleeding [CSPEB] occurred in 6.2% of patients. The underlying cause for the bleeding is unclear.
We suspect that there is a possibility the clotting system gets disturbed slightly during the procedure in some patients. A special blood test looking for clotting abnormalities may help us evaluate if this theory is true or not.

This study will test for clotting abnormalities before and after endoscopic mucosal resection (EMR).

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and are undergoing EMR for large sessile colonic polyps.

Study details
All participants will have a blood test immediately before and after the EMR to check for clotting abnormalities. Participants will be asked to return to the clinic for post-procedure follow-up 2-3 days after the procedure to determine any occurrences of post-endoscopic bleeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73850 0
A/Prof Bernd Froessler
Address 73850 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112

Country 73850 0
Australia
Phone 73850 0
+61881829806
Fax 73850 0
Email 73850 0
bernd.froessler@sa.gov.au
Contact person for public queries
Name 73851 0
A/Prof Bernd Froessler
Address 73851 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 73851 0
Australia
Phone 73851 0
+61881829806
Fax 73851 0
Email 73851 0
bernd.froessler@sa.gov.au
Contact person for scientific queries
Name 73852 0
A/Prof Bernd Froessler
Address 73852 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country 73852 0
Australia
Phone 73852 0
+61881829806
Fax 73852 0
Email 73852 0
bernd.froessler@sa.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary