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临床试验/NCT02682368
NCT02682368已完成不适用

Multicentric Point of Care UltraSound by Surgeons Trial

Connolly Hospital Blanchardstown5 个研究点 分布在 4 个国家目标入组 183 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
5
主要终点
Sensitivity POCUS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Age under 18 (ethical and consent issues)
  • Obesity (BMI ≥ 30)-difficulty in performing USS
  • Previously documented gallstones within the last 2 months for non-critical presentations
  • Previously documented diverticulitis within the last 2 months for non-critical presentations
  • POCUS performed after official report (for training purposes)
  • Previous colonic resection, particularly left sided or sigmoid colon.
  • Previous cholecystectomy

结局指标

主要结局

Sensitivity POCUS

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

POCUS and radiology/surgery correlation

时间窗: Up to 3 years, after the all the patients are included

Cohen's Kappa for agreement between POCUS and radiology

次要结局

  • Likelihood ratio(Up to 3 years)
  • Radiology turnaround time(Up to 1 week)
  • Surgery turnaround time(Between 6 and 48 hours, when emergency surgery would be expected)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel B Dumbrava, MD

General Surgery Trainee

Connolly Hospital Blanchardstown

研究点 (5)

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