Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03471156




Registration number
NCT03471156
Ethics application status
Date submitted
9/07/2017
Date registered
20/03/2018
Date last updated
29/06/2023

Titles & IDs
Public title
Prospective Evaluation of Pain Assessment and Management Protocol for Post-procedural Pain After Endoscopic Mucosal Resection of Colonic Polyps >20mm
Scientific title
Persistent Pain After Colonic Endoscopic Mucosal Resection: Predictors, a Management Algorithm and Outcomes
Secondary ID [1] 0 0
LNR/15/WMEAD/25
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Endoscopic Mucosal Resection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Post EMR - Patients are observed post EMR procedure for pain. Standard of care data is collected
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with EMR related pain post-procedurally
Timepoint [1] 0 0
up to 24 hours
Secondary outcome [1] 0 0
Correlate post-procedural pain with procedural data
Timepoint [1] 0 0
up to 24 hours

Eligibility
Key inclusion criteria
* All patients referred to Westmead Hospital Endoscopy Unit to undergo an EMR of a colonic lesion reported to be =20mm in size.
* Age =18 years.
* Patients able to give informed consent to involvement in the trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to sign informed consent.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2021
Sample size
Target
Accrual to date
Final
325
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
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03471156