Multicentric Point of Care UltraSound by Surgeons Trial

Completed

• Conditions: Biliary Disease; Diverticulitis, Colonic; Gallstone; Cholecystitis, Acute; Abscess Pelvic
• Interventions: Diagnostic Test: Radiology report; Diagnostic Test: Point of Care Ultrasound by Surgeons (POCUSS); Procedure: Surgery-Intra-operative findings

• Registration Number: NCT02682368
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiology Report	Radiology report	Departmental imaging and reports.
POCUSS Trial-1 Acute Biliary Disease	Point of Care Ultrasound by Surgeons (POCUSS)	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.
POCUSS Trial-2 Acute Diverticulitis	Point of Care Ultrasound by Surgeons (POCUSS)	Patients with suspected diverticulitis will undergo POCUS. The results will be compared to the subsequent findings by imagistic means or at time of surgery.
Surgical diagnostic	Surgery-Intra-operative findings	Intraoperative findings of patients that undergo emergency surgery.

Primary Outcome Measures

Name	Time	Method
POCUS and radiology/surgery correlation	Up to 3 years, after the all the patients are included	Cohen's Kappa for agreement between POCUS and radiology
Sensitivity POCUS	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.
Specificity POCUS	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.
Positive predictive value	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.
Negative predictive value	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.

Secondary Outcome Measures

Name	Time	Method
Likelihood ratio	Up to 3 years	Likelihood ratio for a positive test result = sensitivity/(1 - specificity); Likelihood ratio for a negative test result = (1 - sensitivity)/specificity
Radiology turnaround time	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.
Surgery turnaround time	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.

Trial Locations

Locations (5)

Torrevieja University Hospital; 🇪🇸 Torrevieja, Alicante, Spain

General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro; 🇮🇹 Ponte San Pietro, Bergamo, Italy

Connolly Hospital Blanchardstown; 🇮🇪 Dublin, Dublin 15, Ireland

Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP; 🇵🇹 Viseu, Centro Region, Portugal

General Surgery Department, ASUITS, Cattinara Hospital; 🇮🇹 Trieste, Italy