Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03471156 |
Other study ID # |
LNR/15/WMEAD/25 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 27, 2015 |
Est. completion date |
September 1, 2021 |
Study information
Verified date |
June 2023 |
Source |
Western Sydney Local Health District |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.