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Trial registered on ANZCTR


Registration number
ACTRN12621001644853
Ethics application status
Approved
Date submitted
22/10/2021
Date registered
30/11/2021
Date last updated
30/11/2021
Date data sharing statement initially provided
30/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety of anticoagulation in elective colonoscopy
Scientific title
Safety of uninterrupted peri-procedural direct-acting oral anticoagulation during colonoscopy
Secondary ID [1] 305626 0
None
Universal Trial Number (UTN)
Trial acronym
SuDOC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 324057 0
Peri-procedural care 324058 0
Elective colonoscopy 324282 0
Condition category
Condition code
Blood 321571 321571 0 0
Other blood disorders
Oral and Gastrointestinal 321777 321777 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
Guidelines for anticoagulation management universally recommend temporary cessation of direct-acting oral anti-coagulants (DOACs) prior to elective colonoscopy. These medications include: Apixaban (either 5mg or 2.5mg taken twice a day), Dabigatran (150mg or 110mg taken twice a day) and Rivaroxaban (20mg or 15mg taken once a day). Our aim is to demonstrate non-inferiority of uninterrupted DOAC in terms of peri-procedural complications in patients on DOAC therapy for risk of thrombosis (intervention arm).

The exact doses for each patient varies depending upon the indication for the medication as well as patient co-morbidities. These will not be dictated by the trial.

To ensure standardization, all procedures in this study will be performed by three nationally accredited consultant Gastroenterologists including the study investigator or a senior endoscopy fellow under direct supervision.

Day of the procedure:
The endoscopist will be made aware that the patient is a participant of this study however will be blinded to the arm. The patient’s timing of cessation of anticoagulation will be confirmed by the admitting nursing staff and be recorded on a standard form.

All colorectal polyps amenable to endoscopic removal at index colonoscopy as per clinical care will be removed using cold-snare polypectomy (CaptivatorTM Cold or SnareMaster Plus) or hot-snare (CaptivatorTM II). The transected polyp will be sucked into a trap or via the scope to the anus. The method of resection, i.e. hot versus cold, en-bloc versus piecemeal or the inject-and-resect technique using methylene blue with or without epinephrine will be at the discretion of the proceduralist.

On average, an average colonoscopy is expected to take a total of 15-30 minutes.

Intraprocedural bleeding is defined as bleeding persisting for greater than 60 seconds during the procedure requiring endoscopic intervention. Usual methods of controlling intra-procedural bleeding include application of clips, thermal treatment or injection of submucosal epinephrine. Routine prophylactic clip closure will follow current clinical practice at our facility where routine clip closure is performed for hot polypectomy sites but not cold polypectomy. If decision to proceed with clipping, this will be performed using Instinct® Endoscopic clip or ResolutionTM Clip.

Patients will follow standard post procedure recovery in stages 1 and 2 in the unit. Written post-procedural instructions will be provided as per usual practice post colonoscopy on potential problems and contact details for advice.
Intervention code [1] 322028 0
Prevention
Comparator / control treatment
The above described intervention arm will be compared to temporary anticoagulation interruption prior to elective colonoscopy and polypectomy (standard of care arm).

Standard of care arm:
- If the DOAC is a twice a day dose, the patients will omit three doses of the medication, i.e. they will not take the medication on the day of and the day prior to the procedure.
- If, the medication is taken once a day (morning or evening), they will omit the medication on the day prior to the procedure as well as the day of the procedure.
- Anticoagulation will be re-commenced at the next scheduled dose more than 24 hours after the procedure
o If DOAC taken twice a day, they will re-commence after missing the dose on the evening of the procedure and the morning after. They will resume the evening dose day after the procedure.
o If DOAC taken once a day, they will omit the day after the procedure then resume the next day.

In order to monitor adherence to the comparator treatment, patient’s timing of cessation of anticoagulation will be confirmed by the admitting nursing staff and be recorded on a standard form.
Control group
Active

Outcomes
Primary outcome [1] 329334 0
Intraprocedural bleeding (IPB) or clinically significant post-endoscopic bleeding (CSPEB). This is defined as bleeding persisting for greater than 60 seconds during the procedure requiring endoscopic intervention.
This information will be collected as reported by the endoscopist in the procedure report.

Timepoint [1] 329334 0
During the polypectomy procedure.
Primary outcome [2] 329533 0
Need for intervention during the procedure to stop bleeding. Usual methods of controlling intra-procedural bleeding include application of clips, thermal treatment or injection of submucosal epinephrine. Routine prophylactic clip closure will follow current clinical practice at our facility where routine clip closure is performed for hot polypectomy sites but not cold polypectomy. If decision to proceed with clipping, this will be performed using Instinct® Endoscopic clip or ResolutionTM Clip.
This information will be collected as reported by the endoscopist in the procedure report.
Timepoint [2] 329533 0
During the polypectomy procedure.
Secondary outcome [1] 402174 0
Hospitalisations within 30 days of index polypectomy as reported by participant or collected by phone interview at 30 days post procedure. Additionally, if the patient were to present to any other hospital in Queensland, a standardised flagging method will be employed using iEMR (“Power trials”) to allow a message to appear on patient record suggesting their trial participation.
Timepoint [1] 402174 0
30 days post colonoscopy.
Secondary outcome [2] 402175 0
The incidence of each of the thromboembolic events listed will be assessed as a composite secondary outcome. Thromboembolic events include: stroke, myocardial infarction or a peripheral thrombus.

1) Patients are encouraged to contact us if there are any events post colonoscopy.
2) If the patient were to present to any other hospital in Queensland, a standardised flagging method will be employed using iEMR (“Power trials”) to allow a message to appear on patient record suggesting their trial participation.
3) It is standard practice to send a message to patients using short message service (SMS) at the 30-day mark post procedure. to enquire regarding their wellbeing.
4) Study participants will receive a structured telephone interview at 30 days to enquire regarding any thromboembolic event.
Timepoint [2] 402175 0
30 days post colonoscopy.
Secondary outcome [3] 402177 0
Patient acceptance or beliefs regarding anticoagulation. This is a composite secondary outcome. This will be assessed with the use of a study-specific questionnaire that is completed based on patients answers on the phone at the time of a semi-structured telephone interview at 30 days post colonoscopy. This will be completed by a single health professional (primary investigator).
Timepoint [3] 402177 0
30 days post colonoscopy.

Eligibility
Key inclusion criteria
1) Patients undergoing elective colonoscopy
2) Chronically anti-coagulated with DOACs (Apixaban/Dabigatran/Rivaroxaban)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Individual characteristics:
o Concurrent antiplatelet therapy prescribed
o Discharge location distance from the hospital of greater than 100 kilometres
o Individuals unable to give consent
o Patients with renal impairment (defined as eGFR <45)

2) Continuation of anticoagulation is not advised:
o Prior peri-procedural bleeding requiring anticoagulation cessation/intervention/hospitalisation

3) Interruption to anticoagulation not recommended:
o Thromboembolic event in the preceding 3 months
o Active malignancy

4) Procedure planned to be performed by alternative clinician not participating in the study

5) Endoscopic factors:
o Emergency procedure
o Concurrent endoscopy being performed on same day
o Planned therapeutic procedure (i.e. large polypectomy/endo-mucosal resection/endoscopic submucosa dissection/dilatation)
o Expected high burden of polyps (i.e. known polyposis syndrome not yet completed clearance colonoscopy)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation where an equal number of unlabelled opaque envelopes will be assigned to each arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20827 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 35652 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 309986 0
Hospital
Name [1] 309986 0
Queen Elizabeth II Jubilee Hospital
Country [1] 309986 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Tutticci
Address
QEII Jubilee Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country
Australia
Secondary sponsor category [1] 311035 0
Individual
Name [1] 311035 0
Dr Shweta Sharma
Address [1] 311035 0
Queen Elizabeth II Jubilee Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country [1] 311035 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309695 0
Royal Brisbane & Women’s Hospital HREC
Ethics committee address [1] 309695 0
Ethics committee country [1] 309695 0
Australia
Date submitted for ethics approval [1] 309695 0
Approval date [1] 309695 0
18/10/2021
Ethics approval number [1] 309695 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115070 0
Dr Nicholas Tutticci
Address 115070 0
Queen Elizabeth II Jubilee Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country 115070 0
Australia
Phone 115070 0
+61412530925
Fax 115070 0
Email 115070 0
nick_tutticci@yahoo.com.au
Contact person for public queries
Name 115071 0
Shweta Sharma
Address 115071 0
Queen Elizabeth II Jubilee Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country 115071 0
Australia
Phone 115071 0
+61 430325130
Fax 115071 0
Email 115071 0
shweta.ssharma@gmail.com
Contact person for scientific queries
Name 115072 0
Shweta Sharma
Address 115072 0
Queen Elizabeth II Jubilee Hospital
Kessels Rd &, Troughton Rd, Coopers Plains QLD 4108
Country 115072 0
Australia
Phone 115072 0
+61 430325130
Fax 115072 0
Email 115072 0
shweta.ssharma@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13706Study protocol    383003-(Uploaded-22-10-2021-07-19-09)-Study-related document.docx
13707Informed consent form    383003-(Uploaded-22-10-2021-07-19-46)-Study-related document.doc



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.