The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02198729




Registration number
NCT02198729
Ethics application status
Date submitted
17/07/2014
Date registered
24/07/2014
Date last updated
5/07/2019

Titles & IDs
Public title
Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection
Scientific title
Endoscopic Submucosal Dissection Versus Endoscopic Mucosal Resection for Sessile Polyps and Laterally Spreading Lesions of the Rectum - a Prospective Randomised Trial
Secondary ID [1] 0 0
HREC2013/10/4.2(3830)
Universal Trial Number (UTN)
Trial acronym
RESDEMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
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
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Submucosal Dissection
Treatment: Surgery - Endoscopic Mucosal Resection

Active Comparator: Endoscopic Mucosal Resection - Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.

Experimental: Endoscopic Submucosal Dissection - Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.


Treatment: Surgery: Endoscopic Submucosal Dissection


Treatment: Surgery: Endoscopic Mucosal Resection


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

Outcomes
Primary outcome [1] 0 0
Recurrence - Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
One piece resection rate - Rate of en bloc resection
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Technical success of EMR - Rate of initial technical success
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Recurrence - Recurrence tissue observed at follow up colonoscopies over a 3 year period
Timepoint [3] 0 0
up to 3 years
Secondary outcome [4] 0 0
Safety - Safety outcomes measured in the form of follow up phone calls.
Timepoint [4] 0 0
14 days

Eligibility
Key inclusion criteria
- Can give informed consent to trial participation

- Lesion size 20 mm to 50 mm

- Laterally spreading or sessile polyp morphology
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous resection or attempted resection of target adenoma lesion

- Endoscopic appearance of invasive malignancy

- Age less than 18 years

- Pregnancy

- Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)

- Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior
to procedure

- American Society of Anesthesiology (ASA) Grade IV-V

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
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 Endoscopy Unit - 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
The investigators have recently become proficient in a new, and we believe more effective
technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves
removing the polyp in one piece. It is preferable to remove the polyp in one piece as it
minimises the chance of leaving residual polyp tissue behind. There have also been recent
studies overseas that have shown this new technique to be quite effective. In this study,
half of the patients will receive the newly developed technique of polyp removal (ESD), while
the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This
study will allow us to show which technique results in lower recurrence rates and is more
effective.
Trial website
https://clinicaltrials.gov/show/NCT02198729
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Sonson
Address 0 0
Country 0 0
Phone 0 0
98455555
Fax 0 0
Email 0 0
Rebecca.Sonson@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02198729