An observational study in Biliary Disease, Gallstone; Cholecystitis, Acute and Diverticulitis, Colonic, sponsored by Connolly Hospital Blanchardstown. Completed at 5 sites in 4 countries. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-25.
Sponsored by Connolly Hospital Blanchardstown · Observational
Acute gallbladder pathology and acute diverticulitis are common conditions met in emergency departments and comprise the bulk of admissions throughout general surgical calls. Both entities need imagistic description to tailor further management, which may be not readily available at the moment of patient's presentation. These delays may lose the window of opportunity for timed, quality decision making and may induce increased length of stay and subsequent increased costs.
Ultrasound scanning has become very popular over the last half century and the equipment has become more compact, of a higher quality and less expensive, which has facilitated the growth of point-of-care ultrasonography - POCUS - that is, ultrasound performed and interpreted by the clinician at the bedside. The concept of an 'ultrasound stethoscope' is rapidly moving from theory to reality.
There are a number of studies and case reports that are highlighting the advantages of POCUS, but still common grounds need to be sought after. Some countries, like USA and Germany, incorporate basic ultrasound in their resident's curriculum among different specialties.
In the author's knowledge and based on the literature, there are a few-second-to-none studies regarding POCUS involving strictly the surgeons. The hypothesis of this study is that, surgeon performed ultrasound can be as accurate as the radiologists' findings for basic diagnostics in the aforementioned pathology, leading to real time decision making in the benefit of the patient.
The closing remark is that by learning and doing these procedures the surgeon performing POCUS doesn't undermine his/her radiologist colleague's authority and skill. The big picture is that some basic tasks are transferrable and if used in an appropriate and methodical manner the final common goal - the benefit of the patient - is readily achieved.
The study was accepted as a Master of Surgery Thesis by Research (MCh) at the Royal College of Surgeons in Ireland (RCSI)
There will be two parallel studies done at the same time:
STUDY DESIGN
Patients with suspected acute biliary disease or acute diverticulitis will undergo POCUS performed by the surgeons enrolled in the study.
These patients are recruited from either
4a. The same patients will have a departmental imagistic investigation (ultrasound, CT) reported by qualified radiologists.
4b. In the event of emergency surgery without prior departmental imaging, POCUS will be compared to the intra-operative findings.
DISCLAIMER:
Specific for this study, patient data will be anonymous and in line with General Data Protection Regulation (GDPR) (EU) 2016/679 law. Data protection is designed by default. There will be NO patients' personal name, surname, home address or date of birth needed or uploaded. Each patient will be represented by an unique identification number provided by the hospital. Only gender and age will be recorded as these will be necessary for the final data analysis and results. Once the study has finished, the data will be erased.
The same rules will be applied in hospitals from other countries that will get involved in the study.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 183 is below the median of 220 across 29 observational studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Connolly Hospital Blanchardstown is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the Emergency Department with a clinical suspicion of acute cholecystitis and/or acute sigmoid diverticulitis.
POCUS-1 Inclusion Criteria - adapted after Tokyo Guidelines 2018
POCUS-2 Inclusion Criteria
POCUSS-1 and 2 Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with suspected biliary pathology which will undergo POCUS. The results will be compared to the subsequent findings by imagistic means or at time of surgery.
Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS)
Patients with suspected diverticulitis will undergo POCUS. The results will be compared to the subsequent findings by imagistic means or at time of surgery.
Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS)
Departmental imaging and reports.
Diagnostic Test: Radiology report
Intraoperative findings of patients that undergo emergency surgery.
Procedure: Surgery-Intra-operative findings
POCUSS-1. To identify the gallbladder and it's contents, complications and perform measurements, elicit sonographic Murphy. POCUSS-2: To perform focused left lower quadrant sonography and identify bowel wall thickness, diverticulae, measure the colonic wall thickness, assess pericolic fat and detect possible complications; evaluate sensibility on graded compression.
Also known as: Sonos®, BK Ultrasound®
Radiologist report compared to the point of care ultrasound impression.
Also known as: NIMIS: The National Integrated Medical Imaging System
Intra-operative findings compared to the previously performed point of care ultrasound.
Sensitivity POCUS
Sensitivity was defined as the number of patients with a positive detection at POCUS of acute biliary disease or acute diverticulitis divided by the number of patients with pathological findings of the gallbladder or bowel as a final diagnosis.
Time frame: Up to 3 years, after the all the patients are included
Specificity POCUS
Specificity was defined as the number of patients with a negative POCUS for cholecystitis or diverticulitis, divided by the number of patients without pathological findings.
Time frame: Up to 3 years, after the all the patients are included
Positive predictive value
The number of patients with a true-positive detection at POCUS of gallbladder or bowel alteration divided by the total number of patients with a positive detection at POCUS.
Time frame: Up to 3 years, after the all the patients are included
Negative predictive value
The number of patients with a true-negative detection at POCUS of gallbladder or bowel alteration divided by the total number of patients with a negative detection at ultrasound.
Time frame: Up to 3 years, after the all the patients are included
POCUS and radiology/surgery correlation
Cohen's Kappa for agreement between POCUS and radiology
Time frame: Up to 3 years, after the all the patients are included
Radiology turnaround time
Time difference (in hours) between radiologist report and POCUS. For each participant date and time will be recorded in REDCap for both POCUS and radiology report. Simple arithmetic subtraction will be used as an equation cell (datediff). Then mean and median will be calculated to include all patients in the study.
Time frame: Up to 1 week
Surgery turnaround time
Time difference (in hours) between the start of surgery and POCUS. For each participant date and time will be recorded in REDCap for both POCUS and surgical intervention. Simple arithmetic subtraction will be used in a calculation cell (datediff). Then mean and median will be calculated to include all patients in the study.
Time frame: Between 6 and 48 hours, when emergency surgery would be expected
Likelihood ratio
Likelihood ratio for a positive test result = sensitivity/(1 - specificity) Likelihood ratio for a negative test result = (1 - sensitivity)/specificity
Time frame: Up to 3 years
Plan to share: No — Specific for this study, patient data will be anonymous and in line with General Data Protection Regulation (GDPR) (EU) 2016/679 law. Data protection is designed by default. There will be NO patients' personal name, surname, home address or date of birth needed or uploaded. Once the study has finished, the working data will be erased. Only the processed data and statistical analysis will be preserved.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Connolly Hospital Blanchardstown