Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01368289




Trial ID
NCT01368289
Ethics application status
Date submitted
6/06/2011
Date registered
6/06/2011
Date last updated
13/03/2018

Titles & IDs
Public title
Australian Multicentre Colonic Endoscopic Mucosal Resection Study
Scientific title
Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study
Secondary ID [1] 0 0
ACE/EMR
Universal Trial Number (UTN)
Trial acronym
ACEEMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Mucosal Resection

Colonic Polyps - Patients who present with colonic polyps >20mm


Treatment: Surgery: Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of large sessile colonic polyps.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Technical success for Endoscopic resection - To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps. The utility of endoscopic criteria to stratify for the risk of Submucosal Invasive Cancer was also assessed.
Timepoint [1] 0 0
6-60 months

Eligibility
Key inclusion criteria
- Large sessile polyp (equal to or greater than 20mm)

- Intention to perform EMR

- Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Colonic polyps less than 20mm

- Aged younger then 18 years.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A prospective, multicentre, observational study of all patients referred for endoscopic
resection of sessile colorectal polyps sized =20 mm conducted with intention to treat
analysis.
Trial website
https://clinicaltrials.gov/show/NCT01368289
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke
Address 0 0
Westmead Hospital - Endoscopy Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Bourke
Address 0 0
Country 0 0
Phone 0 0
0298459779
Fax 0 0
Email 0 0
westmeadendoscopyresearch@gmail.com
Contact person for scientific queries