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/ct2/show/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
Endoscopic mucosal resection (EMR) of large (=20 mm) laterally spreading colonic lesions
(LSL) is safe, effective and superior to surgery. This advantage is based on a day stay model
of care, however the most common adverse event is abdominal pain and this is a major
impediment to this efficiency. No prospective data exist on the optimal selection of
analgesics, the necessary recovery period or the triggers that should alert the practitioner
to a more serious trajectory and the need for escalation of care.

We aimed to characterise potential predictors for persistent (>5 minutes) post-procedural
pain (PP) and develop a simple and effective management algorithm for patients with PP based
on the need for analgesics in recovery.

Data on consecutive patients with a LSL referred for EMR at a single, tertiary referral
centre were included. Patient and lesion characteristics and peri-procedural data were
prospectively collected. Standard post EMR care included 2 hours in first stage recovery
followed by 1 hour in 2nd stage recovery where clear fluids were given and discharge after if
the patients were well. PP was graded from 0 to 10 using a Visual Analogue Scale (VAS). If PP
occurred >5 minutes, 1 gram of paracetamol was administered parenterally and outcomes were
monitored. If pain settled the patient was transferred to second stage recovery after medical
review. PP >30 minutes lead to clinical review and upgrade of analgesics to fentanyl, with a
starting dose of 25 micrograms (mcg) up to a maximum of 100 mcg. Investigations, admission
and interventions for PP are recorded.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03471156
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03471156