POCUSS: Multicentric Point of Care UltraSound by Surgeons Trial

Sponsor

Connolly Hospital Blanchardstown (Other)

Overall Status

Completed

CT.gov ID

NCT02682368

Collaborator

Royal College of Surgeons, Ireland (Other), Modular UltraSound ESTES Course (MUSEC) (Other), European Socierty for Trauma and Emergency Surgery (Other)

183

Enrollment

Locations

Actual Duration (Months)

36.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Disease Gallstone; Cholecystitis, Acute Diverticulitis, Colonic Abscess Pelvic	Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS) Diagnostic Test: Radiology report Procedure: Surgery-Intra-operative findings

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

Study Type:

Observational

Actual Enrollment :

183 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicentric Point of Care UltraSound by Surgeons Trial

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS) 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. Other Names: Sonos®, BK Ultrasound®
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.	Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS) 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. Other Names: Sonos®, BK Ultrasound®
Radiology Report Departmental imaging and reports.	Diagnostic Test: Radiology report Radiologist report compared to the point of care ultrasound impression. Other Names: NIMIS: The National Integrated Medical Imaging System
Surgical diagnostic Intraoperative findings of patients that undergo emergency surgery.	Procedure: Surgery-Intra-operative findings Intra-operative findings compared to the previously performed point of care ultrasound.

Outcome Measures

Primary Outcome Measures

Sensitivity POCUS [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 [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 [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 [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 [Up to 3 years, after the all the patients are included]
Cohen's Kappa for agreement between POCUS and radiology

Secondary Outcome Measures

Radiology turnaround time [Up to 1 week]
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.
Surgery turnaround time [Between 6 and 48 hours, when emergency surgery would be expected]
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.
Likelihood ratio [Up to 3 years]
Likelihood ratio for a positive test result = sensitivity/(1 - specificity) Likelihood ratio for a negative test result = (1 - sensitivity)/specificity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connolly Hospital Blanchardstown	Dublin	Dublin 15	Ireland	Dublin 15
2	General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro	Ponte San Pietro	Bergamo	Italy
3	General Surgery Department, ASUITS, Cattinara Hospital	Trieste		Italy	34149
4	Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP	Viseu	Centro Region	Portugal
5	Torrevieja University Hospital	Torrevieja	Alicante	Spain	03185

Sponsors and Collaborators

Connolly Hospital Blanchardstown
Royal College of Surgeons, Ireland
Modular UltraSound ESTES Course (MUSEC)
European Socierty for Trauma and Emergency Surgery

Investigators

Study Director: Thomas N Walsh, MCh MD FRCSI, Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
Study Chair: Gary A Bass, MBBCh MSc MRCS, Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
Principal Investigator: Daniel B Dumbrava, MBBCh, Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland