Multicentric Point of Care UltraSound by Surgeons Trial

Biliary Disease Clinical Trial

— POCUSS  

Official title:

Multicentric Point of Care UltraSound by Surgeons Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682368
• Other study ID #: 15190484
• Secondary ID: 255774
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: Connolly Hospital Blanchardstown
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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:

1. POCUSS-1 for acute biliary disease

2. POCUSS-2 for suspected diverticulitis

STUDY DESIGN

1. 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

1. emergency department

2. outpatients clinic

3. ward consults

2. 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.

3. 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.

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: May 1, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

POCUS-1 Inclusion Criteria - adapted after Tokyo Guidelines 2018

1. RUQ mass/pain/tenderness

2. Murphy's Sign

3. Fever

4. Elevated WBC

5. Elevated CRP

6. Deranged liver function tests

7. Jaundice

POCUS-2 Inclusion Criteria

1. Left iliac fossa tenderness and/or palpable mass

2. Fever

3. Elevated WBC

4. Elevated CRP

5. Peritonism - Left lower quadrant / hypogastrium

6. Per rectum bleeding/mucus discharge

POCUSS-1 and 2 Exclusion Criteria:

1. Age under 18 (ethical and consent issues)

2. Pregnancy

3. Obesity (BMI = 30)-difficulty in performing USS

4. Previously documented gallstones within the last 2 months for non-critical presentations

5. Previously documented diverticulitis within the last 2 months for non-critical presentations

6. POCUS performed after official report (for training purposes)

7. Previous colonic resection, particularly left sided or sigmoid colon.

8. Previous cholecystectomy

Related Conditions & MeSH terms

• Abscess Pelvic
• Biliary Disease
• Cholecystitis
• Cholecystitis, Acute
• Diverticulitis
• Diverticulitis, Colonic
• Gallbladder Diseases
• Gallstone; Cholecystitis, Acute
• Gallstones

Intervention

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.
• Radiology report
Radiologist report compared to the point of care ultrasound impression.

Procedure:
• Surgery-Intra-operative findings
Intra-operative findings compared to the previously performed point of care ultrasound.

Locations

Country	Name	City	State
Ireland	Connolly Hospital Blanchardstown	Dublin	Dublin 15
Italy	General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro	Ponte San Pietro	Bergamo
Italy	General Surgery Department, ASUITS, Cattinara Hospital	Trieste
Portugal	Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP	Viseu	Centro Region
Spain	Torrevieja University Hospital	Torrevieja	Alicante

Sponsors (4)

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

Countries where clinical trial is conducted

Ireland,  Italy,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 years, after the all the patients are included
Primary	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.	Up to 3 years, after the all the patients are included
Primary	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.	Up to 3 years, after the all the patients are included
Primary	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.	Up to 3 years, after the all the patients are included
Primary	POCUS and radiology/surgery correlation	Cohen's Kappa for agreement between POCUS and radiology	Up to 3 years, after the all the patients are included
Secondary	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.	Up to 1 week
Secondary	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.	Between 6 and 48 hours, when emergency surgery would be expected
Secondary	Likelihood ratio	Likelihood ratio for a positive test result = sensitivity/(1 - specificity); Likelihood ratio for a negative test result = (1 - sensitivity)/specificity	Up to 3 years