Biliary DiseasePOCUSSNCT02682368
Multicentric Point of Care UltraSound by Surgeons Trial
An observational study of Biliary Disease and Gallstone; Cholecystitis, Acute, run by Connolly Hospital Blanchardstown at 5 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Biliary Disease, Gallstone; Cholecystitis, Acute, Diverticulitis, Colonic
- What is being tested?
- Point of Care Ultrasound by Surgeons (POCUSS), Radiology report and Surgery-Intra-operative findings
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Oct 2015to 1 May 2019
- 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 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
- RUQ mass/pain/tenderness
- Murphy's Sign
- Fever
- Elevated WBC
- Elevated CRP
- Deranged liver function tests
- Jaundice
POCUS-2 Inclusion Criteria
- Left iliac fossa tenderness and/or palpable mass
- Fever
- Elevated WBC
- Elevated CRP
- Peritonism - Left lower quadrant / hypogastrium
- Per rectum bleeding/mucus discharge
POCUSS-1 and 2 Exclusion Criteria:
- Age under 18 (ethical and consent issues)
- Pregnancy
- Obesity (BMI ≥ 30)-difficulty in performing USS
- Previously documented gallstones within the last 2 months for non-critical presentations
- Previously documented diverticulitis within the last 2 months for non-critical presentations
- POCUS performed after official report (for training purposes)
- Previous colonic resection, particularly left sided or sigmoid colon.
- Previous cholecystectomy
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Italy2 sites
General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro
Ponte San Pietro, Bergamo
General Surgery Department, ASUITS, Cattinara Hospital
Trieste, 34149
Portugal1 site
Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP
Viseu, Centro Region
About this study
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.
Read more
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.
Read the detailed description
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:
- POCUSS-1 for acute biliary disease
- POCUSS-2 for suspected diverticulitis
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
- emergency department
- outpatients clinic
- ward consults
- Patients will have the procedure explained to them and then will receive a leaflet with the same information will be handed over. Consent will be obtained (verbal and written) from the patients that wish to be enrolled in the study.
- POCUS is performed and data recorded on REDCap®.
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.
- Data will be collected and stored anonymously and processed with REDCap, Microsoft Excel, IMB SPSS, R-studio
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.
- Being tested
- Point of Care Ultrasound by Surgeons (POCUSS), Radiology report, Surgery-Intra-operative findings
- Keywords
- Surgeon performed ultrasound, Point of care ultrasound
- Medical subject headings
- Gallbladder Diseases, Gallstones, Cholecystitis, Diverticulitis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care Ultrasound by Surgeons (POCUSS)Diagnostic test
Also called Sonos®, BK Ultrasound®
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.
Radiology reportDiagnostic test
Also called NIMIS: The National Integrated Medical Imaging System
Radiologist report compared to the point of care ultrasound impression.
Surgery-Intra-operative findingsProcedure or surgery
Intra-operative findings compared to the previously performed point of care ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| POCUSS Trial-1 Acute Biliary Disease | 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. Receives: Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS) | |
| POCUSS Trial-2 Acute Diverticulitis | Patients with suspected diverticulitis will undergo POCUS. The results will be compared to the subsequent findings by imagistic means or at time of surgery. Receives: Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS) | |
| Radiology Report | Departmental imaging and reports. Receives: Diagnostic Test: Radiology report | |
| Surgical diagnostic | Intraoperative findings of patients that undergo emergency surgery. Receives: Procedure: Surgery-Intra-operative findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 3 years, after the all the patients are included
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start1 Oct 2015
- Primary completion30 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Biliary DiseaseStudies 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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connolly Hospital Blanchardstown
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland, Modular UltraSound ESTES Course (MUSEC), European Society for Trauma and Emergency Surgery
- Responsible party
- Principal investigator, Daniel B Dumbrava, MD, Connolly Hospital Blanchardstown
- Investigators
- Thomas N Walsh, MCh MD FRCSI, Study director, Connolly Hospital Blanchardstown; Royal College of Surgeons in IrelandGary A Bass, MBBCh MSc MRCS, Study chair, Connolly Hospital Blanchardstown; Royal College of Surgeons in IrelandDaniel B Dumbrava, MBBCh, Principal investigator, Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682368
- Sponsor's protocol ID
- 15190484
- Other IDs
- 255774
- Acronym
- POCUSS
- Status last verified
- Jul 2019
- First submitted
- 25 Jan 2016
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dumbrava BD, Bass GA, Jumean A, Birido N, Corbally M, Pereira J, Biloslavo A, Zago M, Walsh TN. The Accuracy of Point-of-Care Ultrasound (POCUS) in Acute Gallbladder Disease. Diagnostics (Basel). 2023 Mar 26;13(7):1248. doi: 10.3390/diagnostics13071248.
PubMed 37046466Dumbrava BD, Abdulla HS, Pereira J, Biloslavo A, Zago M, Hashem JH, Kumar N, Corbally M, Bass GA, Walsh TN. Surgeon-Performed Point-of-Care Ultrasound in the Diagnosis of Acute Sigmoid Diverticulitis: A Pragmatic Prospective Multicenter Cohort Study. Cureus. 2023 Jan 3;15(1):e33292. doi: 10.7759/cureus.33292. eCollection 2023 Jan.
PubMed 36741667
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Point of Care UltraSound by Surgeons Trial
- ClinicalTrials.gov ID
- NCT02682368
- Acronym / sponsor ID
- POCUSS / 15190484
- Keywords
- Surgeon performed ultrasound, Point of care ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Connolly Hospital BlanchardstownUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland, Modular UltraSound ESTES Course (MUSEC), European Society for Trauma and Emergency Surgery
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 15 Feb 2016 (estimated)
- 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.
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.
Detailed description
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:
- POCUSS-1 for acute biliary disease
- POCUSS-2 for suspected diverticulitis
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
- emergency department
- outpatients clinic
- ward consults
- Patients will have the procedure explained to them and then will receive a leaflet with the same information will be handed over. Consent will be obtained (verbal and written) from the patients that wish to be enrolled in the study.
- POCUS is performed and data recorded on REDCap®.
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.
- Data will be collected and stored anonymously and processed with REDCap, Microsoft Excel, IMB SPSS, R-studio
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POCUSS Trial-1 Acute Biliary Disease | – | Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS)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. |
| POCUSS Trial-2 Acute Diverticulitis | – | 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. |
| Radiology Report | – | Diagnostic Test: Radiology reportDepartmental imaging and reports. |
| Surgical diagnostic | – | Procedure: Surgery-Intra-operative findingsIntraoperative findings of patients that undergo emergency surgery. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Emergency Department with a clinical suspicion of acute cholecystitis and/or acute sigmoid diverticulitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care Ultrasound by Surgeons (POCUSS)Also: Sonos®, BK Ultrasound®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. | Diagnostic test | POCUSS Trial-1 Acute Biliary Disease, POCUSS Trial-2 Acute Diverticulitis |
| Radiology reportAlso: NIMIS: The National Integrated Medical Imaging SystemRadiologist report compared to the point of care ultrasound impression. | Diagnostic test | Radiology Report |
| Surgery-Intra-operative findingsIntra-operative findings compared to the previously performed point of care ultrasound. | Procedure or surgery | Surgical diagnostic |
Primary outcome
Sensitivity POCUS
Time frame: Up to 3 years, after the all the patients are included
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.
Specificity POCUS
Time frame: Up to 3 years, after the all the patients are included
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.
Positive predictive value
Time frame: Up to 3 years, after the all the patients are included
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.
Negative predictive value
Time frame: Up to 3 years, after the all the patients are included
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.
POCUS and radiology/surgery correlation
Time frame: Up to 3 years, after the all the patients are included
Cohen's Kappa for agreement between POCUS and radiology
3 secondary outcomes
Radiology turnaround time
Time frame: Up to 1 week
Surgery turnaround time
Time frame: Between 6 and 48 hours, when emergency surgery would be expected
Likelihood ratio
Time frame: Up to 3 years
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 25 Jul 2019.
- Derived from this study: PubMed 37046466Dumbrava BD, Bass GA, Jumean A, Birido N, Corbally M, Pereira J, Biloslavo A, Zago M, Walsh TN. The Accuracy of Point-of-Care Ultrasound (POCUS) in Acute Gallbladder Disease. Diagnostics (Basel). 2023 Mar 26;13(7):1248. doi: 10.3390/diagnostics13071248.
- Derived from this study: PubMed 36741667Dumbrava BD, Abdulla HS, Pereira J, Biloslavo A, Zago M, Hashem JH, Kumar N, Corbally M, Bass GA, Walsh TN. Surgeon-Performed Point-of-Care Ultrasound in the Diagnosis of Acute Sigmoid Diverticulitis: A Pragmatic Prospective Multicenter Cohort Study. Cureus. 2023 Jan 3;15(1):e33292. doi: 10.7759/cureus.33292. eCollection 2023 Jan.
- Individual participant dataSharing planned: 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.
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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.
Thomas N Walsh, MCh MD FRCSI study director
Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
Gary A Bass, MBBCh MSc MRCS study chair
Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
Daniel B Dumbrava, MBBCh principal investigator
Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Disease and Gallstone; Cholecystitis, Acute, run by Connolly Hospital Blanchardstown at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Ireland, Portugal, Spain. 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?
Sensitivity POCUS (time frame: Up to 3 years, after the all the patients are included). The study lists 5 primary outcomes in all. 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 NCT02682368, which also lists 2 linked publications.
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 25 Jul 2019.