Clinical trial NCT02682368: Multicentric Point of Care UltraSound by Surgeons Trial
Official title: Multicentric Point of Care UltraSound by Surgeons Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Disease
Gallstone; Cholecystitis, Acute
Diverticulitis, Colonic
Abscess Pelvic
Keywords: Surgeon performed ultrasound
Point of care ultrasound
Lead sponsor: Connolly Hospital Blanchardstown
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons, Ireland
name: Modular UltraSound ESTES Course (MUSEC)
name: European Society for Trauma and Emergency Surgery
First posted: 2016-02-15
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity POCUS
timeFrame: Up to 3 years, after the all the patients are included
measure: Specificity POCUS
timeFrame: Up to 3 years, after the all the patients are included
measure: Positive predictive value
timeFrame: Up to 3 years, after the all the patients are included
measure: Negative predictive value
timeFrame: Up to 3 years, after the all the patients are included
measure: POCUS and radiology/surgery correlation
timeFrame: Up to 3 years, after the all the patients are included
Secondary outcomes:
measure: Radiology turnaround time
timeFrame: Up to 1 week
measure: Surgery turnaround time
timeFrame: Between 6 and 48 hours, when emergency surgery would be expected
measure: Likelihood ratio
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Connolly Hospital Blanchardstown
state: Dublin 15
city: Ponte San Pietro
country: Italy
facility: General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro
state: Bergamo
city: Trieste
country: Italy
facility: General Surgery Department, ASUITS, Cattinara Hospital
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP
state: Centro Region
city: Torrevieja
country: Spain
facility: Torrevieja University Hospital
state: Alicante
Study officials:
affiliation: Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
name: Thomas N Walsh, MCh MD FRCSI
role: STUDY_DIRECTOR
affiliation: Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
name: Gary A Bass, MBBCh MSc MRCS
role: STUDY_CHAIR
affiliation: Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland
name: Daniel B Dumbrava, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: