NCT02682368

Multicentric Point of Care UltraSound by Surgeons Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Connolly Hospital Blanchardstown · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-04-30
• Completion: 2019-05-01
• First posted: 2016-02-15
• Last updated: 2019-07-25

Locations

5 sites across 4 countries: Ireland, Italy, Portugal, Spain