Multicentric Point of Care UltraSound by Surgeons Trial

NCT ID: NCT02682368

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2019-05-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Point of Care Ultrasound by Surgeons (POCUSS)

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Point of Care Ultrasound by Surgeons (POCUSS)

Intervention Type: DIAGNOSTIC_TEST

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.

Radiology Report

Departmental imaging and reports.

Radiology report

Intervention Type: DIAGNOSTIC_TEST

Radiologist report compared to the point of care ultrasound impression.

Surgical diagnostic

Intraoperative findings of patients that undergo emergency surgery.

Surgery-Intra-operative findings

Intervention Type: PROCEDURE

Intra-operative findings compared to the previously performed point of care ultrasound.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Radiology report

Radiologist report compared to the point of care ultrasound impression.

Intervention Type: DIAGNOSTIC_TEST

Surgery-Intra-operative findings

Intra-operative findings compared to the previously performed point of care ultrasound.

Intervention Type: PROCEDURE

Other Intervention Names

Sonos®, BK Ultrasound®; NIMIS: The National Integrated Medical Imaging System

Eligibility Criteria

Inclusion Criteria

1. RUQ mass/pain/tenderness

2. Murphy's Sign

3. Fever

4. Elevated WBC

5. Elevated CRP

6. Deranged liver function tests

7. Jaundice

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: collaborator

Modular UltraSound ESTES Course (MUSEC)

UNKNOWN

Sponsor Role: collaborator

European Society for Trauma and Emergency Surgery

OTHER

Sponsor Role: collaborator

Connolly Hospital Blanchardstown

OTHER

Sponsor Role: lead

Responsible Party

Daniel B Dumbrava, MD

General Surgery Trainee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas N Walsh, MCh MD FRCSI

Role: STUDY_DIRECTOR

Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland

Gary A Bass, MBBCh MSc MRCS

Role: STUDY_CHAIR

Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland

Daniel B Dumbrava, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Connolly Hospital Blanchardstown; Royal College of Surgeons in Ireland

Locations

Connolly Hospital Blanchardstown

Dublin, Dublin 15, Ireland

General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro

Ponte San Pietro, Bergamo, Italy

General Surgery Department, ASUITS, Cattinara Hospital

Trieste, , Italy

Centro Hospitalar Tondela Viseu - Serviço de Cirurgia Geral - Unidade de Cirurgia HBP

Viseu, Centro Region, Portugal

Torrevieja University Hospital

Torrevieja, Alicante, Spain

Countries

Ireland; Italy; Portugal; Spain

References

Dumbrava BD, Bass GA, Jumean A, Birido N, Corbally M, Pereira J, Biloslavo A, Zago M, Walsh TN. The Accuracy of Point-of-Care Ultrasound (POCUS) in Acute Gallbladder Disease. Diagnostics (Basel). 2023 Mar 26;13(7):1248. doi: 10.3390/diagnostics13071248.

Reference Type: DERIVED

PMID: 37046466 (View on PubMed)

Dumbrava BD, Abdulla HS, Pereira J, Biloslavo A, Zago M, Hashem JH, Kumar N, Corbally M, Bass GA, Walsh TN. Surgeon-Performed Point-of-Care Ultrasound in the Diagnosis of Acute Sigmoid Diverticulitis: A Pragmatic Prospective Multicenter Cohort Study. Cureus. 2023 Jan 3;15(1):e33292. doi: 10.7759/cureus.33292. eCollection 2023 Jan.

Reference Type: DERIVED

PMID: 36741667 (View on PubMed)

Other Identifiers

255774

Identifier Type: OTHER

Identifier Source: secondary_id

15190484

Identifier Type: -

Identifier Source: org_study_id