Multicentric Point of Care UltraSound by Surgeons Trial
Condition: Biliary Disease; Gallstone; Cholecystitis, Acute; Diverticulitis, Colonic; Abscess Pelvic
MeSH terms: Cholecystitis; Diverticulitis; Gallstones; Cholecystitis, Acute; Gallbladder Diseases; Diverticulitis, Colonic
Study type: Observational

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.
    

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.
    

Intervention name(s): Point of Care Ultrasound by Surgeons (POCUSS); Radiology report; Surgery-Intra-operative findings
Intervention type(s): Diagnostic Test; Diagnostic Test; Procedure
Intervention description(s): 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.; Radiologist report compared to the point of care ultrasound impression.; Intra-operative findings compared to the previously performed point of care ultrasound.
Other intervention name(s): Sonos®, BK Ultrasound®; NIMIS: The National Integrated Medical Imaging System
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Surgeon performed ultrasound; Point of care ultrasound