Multicentric Point of Care UltraSound by Surgeons Trial (POCUSS)

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.

Study Overview

• Status: Completed
• Conditions: Diverticulitis, Colonic; Biliary Disease; Gallstone; Cholecystitis, Acute; Abscess Pelvic
• Intervention / Treatment: 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:

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.

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• Ireland
  • Dublin 15
    • Dublin, Dublin 15, Ireland, Dublin 15
      • Connolly Hospital Blanchardstown
• Italy
  • Trieste, Italy, 34149
    • General Surgery Department, ASUITS, Cattinara Hospital
  • Bergamo
    • Ponte San Pietro, Bergamo, Italy
      • General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro
• Portugal
  • Centro Region
    • Viseu, Centro Region, Portugal
      • Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP
• Spain
  • Alicante
    • Torrevieja, Alicante, Spain, 03185
      • Torrevieja University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department with a clinical suspicion of acute cholecystitis and/or acute sigmoid diverticulitis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Connolly Hospital Blanchardstown
• Collaborators: Royal College of Surgeons, Ireland; European Society for Trauma and Emergency Surgery; Modular UltraSound ESTES Course (MUSEC)
• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Point of care ultrasound; Surgeon performed ultrasound
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Diverticular Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Diverticulosis, Colonic; Cholecystitis; Cholecystitis, Acute; Diverticulitis; Gallstones; Gallbladder Diseases; Diverticulitis, Colonic
• Other Study ID Numbers: 15190484; 255774 (Other Identifier: Trademark act 1996, Irish Patent Office)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No