PainNCT03471156
Prospective Evaluation of Pain Assessment and Management Protocol for Post-procedural Pain After Endoscopic Mucosal Resection of Colonic Polyps >20mm
An observational study of Pain and Endoscopic Mucosal Resection, run by Western Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Endoscopic Mucosal Resection
- How many people
- 325 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Aug 2015to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 were recorded.
Who may be able to join
- 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.
Who cannot join
- Inability to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Pain After Colonic Endoscopic Mucosal Resection: Predictors, a Management Algorithm and Outcomes
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.
Read the detailed description
Large, sessile, colonic polyps of ≥ 20 mm are at increased risk of progressing to colorectal cancer (CRC). Most colonic polyps are small and pedunculated and can be safely removed by conventional polypectomy. Treatment of large polyps however, is challenging but very important in preventing development of CRC, the second leading cause of cancer deaths worldwide. Early detection and treatment of these polyps, possible through vigilant CRC screening via colonoscopy, shows significant reduction in incidence of CRC.
Over the last decade, endoscopic mucosal resection (EMR) has been recognised as a safe and reliable alternative to surgery to remove large, sessile colonic polyps of ≥ 20mm. The benefits of EMR over traditional surgery include reduced risk of peri- and post-operative complications from surgery (particularly in elderly patients with multiple co-morbidities), less health expenditure and reduced length of hospital admission. The majority of patients can be managed safely as outpatients post EMR.
EMR has been proven to be a safer alternative to traditional surgery, but is a technically challenging procedure. The most common complication post procedure is non-specific abdominal pain, which occurs in 10-20% of cases. The cause is often innocent such as simple luminal distension during the procedure. The advent of improved EMR techniques, for example using carbon dioxide instead of air insufflation, significantly reduces incidence of abdominal pain and subsequently need for admission.
Colonic perforation during colonoscopy rates range from 0.06 to 0.1%. Advanced age, female gender, having a colonoscopy indication of abdominal pain or Crohn's disease, result in a statistically higher risk of colonic perforation. In addition, ICU inpatients have substantially greater odds of perforation. A recent study, conducted over twelve years in a total of 110,785 patients undergoing diagnostic and therapeutic colonoscopies, showed one case of colonic perforation associated with EMR.
Currently, it remains difficult to delineate innocent abdominal pain from more serious complications. There are no standard algorithms used in clinical practice to stratify risk post EMR according to patient's symptoms and there are no data supporting previously proposed pain algorithms. There is also a paucity of data regarding pain scales employed in the past to show significant correlation between pain level and risk of perforation or bleeding. The 100mm Visual Analog Scale (VAS) has been documented to have sound correlation in patients presenting to the emergency department with an acute abdomen and could be a useful aid in a formal assessment based on pain post EMR.
With the prospectively recorded data in this study, we aim to validate an algorithm to provide decision support in first stage recovery of Endoscopy Departments. This algorithm on assessment and management of post EMR pain, will identify patients at risk for more serious complications, and will allow health carers to recognize these complications and act more accurately. Ultimately, this will improve patient's outcomes.
- Conditions
- Pain, Endoscopic Mucosal Resection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post EMR | Patients are observed post EMR procedure for pain. Standard of care data is collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with EMR related pain post-procedurally
Patients are observed for pain post-procedurally and data collected on when/how pain is relieved
Measured: up to 24 hours
Secondary outcomes (1)
Correlate post-procedural pain with procedural data
Identify if any patient or lesion factors are predictive of post EMR pain
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start27 Aug 2015
- Primary completion1 Jun 2019
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471156
- Sponsor's protocol ID
- LNR/15/WMEAD/25
- Status last verified
- Jun 2023
- First submitted
- 9 Jul 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desomer L, Tate DJ, Pillay L, Awadie H, Sidhu M, Ahlenstiel G, Bourke MJ. Intravenous paracetamol for persistent pain after endoscopic mucosal resection discriminates patients at risk of adverse events and those who can be safely discharged. Endoscopy. 2023 Jul;55(7):611-619. doi: 10.1055/a-2022-6530. Epub 2023 Jan 30.
PubMed 36716781
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain After Colonic Endoscopic Mucosal Resection: Predictors, a Management Algorithm and Outcomes
- ClinicalTrials.gov ID
- NCT03471156
- Acronym / sponsor ID
- LNR/15/WMEAD/25
- Conditions
- Pain, Endoscopic Mucosal Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Large, sessile, colonic polyps of ≥ 20 mm are at increased risk of progressing to colorectal cancer (CRC). Most colonic polyps are small and pedunculated and can be safely removed by conventional polypectomy. Treatment of large polyps however, is challenging but very important in preventing development of CRC, the second leading cause of cancer deaths worldwide. Early detection and treatment of these polyps, possible through vigilant CRC screening via colonoscopy, shows significant reduction in incidence of CRC.
Over the last decade, endoscopic mucosal resection (EMR) has been recognised as a safe and reliable alternative to surgery to remove large, sessile colonic polyps of ≥ 20mm. The benefits of EMR over traditional surgery include reduced risk of peri- and post-operative complications from surgery (particularly in elderly patients with multiple co-morbidities), less health expenditure and reduced length of hospital admission. The majority of patients can be managed safely as outpatients post EMR.
EMR has been proven to be a safer alternative to traditional surgery, but is a technically challenging procedure. The most common complication post procedure is non-specific abdominal pain, which occurs in 10-20% of cases. The cause is often innocent such as simple luminal distension during the procedure. The advent of improved EMR techniques, for example using carbon dioxide instead of air insufflation, significantly reduces incidence of abdominal pain and subsequently need for admission.
Colonic perforation during colonoscopy rates range from 0.06 to 0.1%. Advanced age, female gender, having a colonoscopy indication of abdominal pain or Crohn's disease, result in a statistically higher risk of colonic perforation. In addition, ICU inpatients have substantially greater odds of perforation. A recent study, conducted over twelve years in a total of 110,785 patients undergoing diagnostic and therapeutic colonoscopies, showed one case of colonic perforation associated with EMR.
Currently, it remains difficult to delineate innocent abdominal pain from more serious complications. There are no standard algorithms used in clinical practice to stratify risk post EMR according to patient's symptoms and there are no data supporting previously proposed pain algorithms. There is also a paucity of data regarding pain scales employed in the past to show significant correlation between pain level and risk of perforation or bleeding. The 100mm Visual Analog Scale (VAS) has been documented to have sound correlation in patients presenting to the emergency department with an acute abdomen and could be a useful aid in a formal assessment based on pain post EMR.
With the prospectively recorded data in this study, we aim to validate an algorithm to provide decision support in first stage recovery of Endoscopy Departments. This algorithm on assessment and management of post EMR pain, will identify patients at risk for more serious complications, and will allow health carers to recognize these complications and act more accurately. Ultimately, this will improve patient's outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post EMR | – | –Patients are observed post EMR procedure for pain. Standard of care data is collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 were recorded.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with EMR related pain post-procedurally
Time frame: up to 24 hours
Patients are observed for pain post-procedurally and data collected on when/how pain is relieved
1 secondary outcome
Correlate post-procedural pain with procedural data
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 36716781Desomer L, Tate DJ, Pillay L, Awadie H, Sidhu M, Ahlenstiel G, Bourke MJ. Intravenous paracetamol for persistent pain after endoscopic mucosal resection discriminates patients at risk of adverse events and those who can be safely discharged. Endoscopy. 2023 Jul;55(7):611-619. doi: 10.1055/a-2022-6530. Epub 2023 Jan 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Endoscopic Mucosal Resection, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with EMR related pain post-procedurally (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.