Multicentric Point of Care UltraSound by Surgeons Trial

NCT02682368 | Completed DMC

• 2 other identifiers: 15190484255774
• Study Type: observational
• Target: 183
• Locations: 4 countries
• Sites: 5

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.

Conditions

Biliary Disease; Gallstone; Cholecystitis, Acute; Diverticulitis, Colonic; Abscess Pelvic

Keywords

Surgeon performed ultrasound; Point of care ultrasound

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Radiology turnaround time

  Up to 1 week

• Surgery turnaround time

  Between 6 and 48 hours, when emergency surgery would be expected

• Likelihood ratio

  Up to 3 years

Study Arms (4)

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 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)

Radiology Report

Departmental imaging and reports.

Diagnostic Test: Radiology report

Surgical diagnostic

Intraoperative findings of patients that undergo emergency surgery.

Procedure: Surgery-Intra-operative findings

Interventions

Point of Care Ultrasound by Surgeons (POCUSS) DIAGNOSTIC_TEST

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®

POCUSS Trial-1 Acute Biliary Disease; POCUSS Trial-2 Acute Diverticulitis

Radiology report DIAGNOSTIC_TEST

Radiologist report compared to the point of care ultrasound impression.

Also known as: NIMIS: The National Integrated Medical Imaging System

Radiology Report

Surgery-Intra-operative findings PROCEDURE

Intra-operative findings compared to the previously performed point of care ultrasound.

Surgical diagnostic

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• RUQ mass/pain/tenderness
• Murphy's Sign
• Fever
• Elevated WBC
• Elevated CRP
• Deranged liver function tests
• Jaundice
• Left iliac fossa tenderness and/or palpable mass
• Fever
• Elevated WBC
• Elevated CRP
• Peritonism - Left lower quadrant / hypogastrium
• Per rectum bleeding/mucus discharge

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

Connolly Hospital Blanchardstown

Dublin, Dublin 15, Dublin 15, Ireland

Location

General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro

Ponte San Pietro, Bergamo, Italy

Location

General Surgery Department, ASUITS, Cattinara Hospital

Trieste, 34149, Italy

Location

Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP

Viseu, Centro Region, Portugal

Location

Torrevieja University Hospital

Torrevieja, Alicante, 03185, Spain

Location

Related Publications (2)

• 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.

  PMID: 37046466 DERIVED

• Dumbrava 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.

  PMID: 36741667 DERIVED

MeSH Terms

Conditions

Gallbladder Diseases; Gallstones; Cholecystitis; Diverticulitis, Colonic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Diverticulitis; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Study Officials

• Thomas N Walsh, MCh MD FRCSI

  Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland

  STUDY DIRECTOR

• Gary A Bass, MBBCh MSc MRCS

  Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland

  STUDY CHAIR

• Daniel B Dumbrava, MBBCh

  Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Trainee

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 15, 2016
• Study Start: October 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: May 1, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); IE (1); PT (1); ES (1)