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Multicentric Point of Care UltraSound by Surgeons Trial (POCUSS)

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ClinicalTrials.gov Identifier: NCT02682368
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Royal College of Surgeons, Ireland
Modular UltraSound ESTES Course (MUSEC)
European Socierty for Trauma and Emergency Surgery
Information provided by (Responsible Party):
Daniel B Dumbrava, MBBCh, Connolly Hospital Blanchardstown

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
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:

  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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Point of Care UltraSound by Surgeons Trial
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Sonos®, BK Ultrasound®

Radiology Report
Departmental imaging and reports.
Diagnostic Test: Radiology report
Radiologist report compared to the point of care ultrasound impression.
Other Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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


Secondary Outcome Measures :
  1. Radiology turnaround time [ Time Frame: 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.

  2. Surgery turnaround time [ Time Frame: 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.

  3. Likelihood ratio [ Time Frame: Up to 3 years ]

    Likelihood ratio for a positive test result = sensitivity/(1 - specificity)

    Likelihood ratio for a negative test result = (1 - sensitivity)/specificity




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682368


Contacts
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Contact: Daniel B Dumbrava, MBBCh 00353894048375 daniel.b.dumbrava@gmail.com
Contact: Gary A Bass, MBBCh MSc MRCS

Locations
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Ireland
Connolly Hospital Blanchardstown Recruiting
Dublin, Dublin 15, Ireland, Dublin 15
Contact: Daniel B Dumbrava, MBBCh         
Contact: Gary A Bass, MBBCh MSc MRCS         
Principal Investigator: Daniel B Dumbrava, MBBCh         
Sub-Investigator: Gary A Bass, MBBCh MSc MRCS         
Italy
General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro Recruiting
Ponte San Pietro, Bergamo, Italy
Contact: Mauro Zago, Professor, MD, FEBS EmSurg         
Principal Investigator: Mauro Zago, Professor, MD, FEBS EmSurg         
General Surgery Department, ASUITS, Cattinara Hospital Recruiting
Trieste, Italy, 34149
Contact: Alan Biloslavo, MD, FACS         
Principal Investigator: Alan Biloslavo, MD, FACS         
Sub-Investigator: Gabriele Bellio         
Portugal
Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP Recruiting
Viseu, Centro Region, Portugal
Contact: Jorge de Almeida Pereira, MD, FEBS EmSurg (Hon)         
Principal Investigator: Jorge de Almeida Pereira, MD, FEBS EmSurg (Hon)         
Spain
Torrevieja University Hospital Recruiting
Torrevieja, Alicante, Spain, 03185
Contact: Luca Ponchietti, FEBS, EBSQ-C         
Principal Investigator: Luca Ponchietti, FEBS, EBSQ-C         
Sponsors and Collaborators
Connolly Hospital Blanchardstown
Royal College of Surgeons, Ireland
Modular UltraSound ESTES Course (MUSEC)
European Socierty for Trauma and Emergency Surgery
Investigators
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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

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Responsible Party: Daniel B Dumbrava, MBBCh, General Surgery Trainee, Connolly Hospital Blanchardstown
ClinicalTrials.gov Identifier: NCT02682368     History of Changes
Other Study ID Numbers: 15190484
255774 ( Other Identifier: Trademark act 1996, Irish Patent Office )
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel B Dumbrava, MBBCh, Connolly Hospital Blanchardstown:
Surgeon performed ultrasound
Point of care ultrasound

Additional relevant MeSH terms:
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Diverticulitis
Cholecystitis
Acalculous Cholecystitis
Gallstones
Gallbladder Diseases
Cholecystitis, Acute
Diverticulitis, Colonic
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Biliary Tract Diseases
Cholelithiasis
Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases