Optimizing the Diagnosis of Acute Appendicitis - Open, Randomized, Parallel Groups, Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Negative appendectomy rate
研究概览
简要总结
Aim of the study: to identify the signs of acute appendicitis delta signs - clinical, laboratory or ultrasound signs, whose change (delta) would allow to identify or deny the diagnosis of acute appendicitis without a computed tomography examination and thus to lower computed tomography rates.
详细描述
This study consists of two parts:
- In the first part investigators enroll all patients (except pregnant) that are refered to Vilnius University Hospital Santaros clinics with suspected acute appendicitis in order to get cohort data. All patient get primary clinical evaluation, laboratory tests (WBC, CRP) an ultrasound examination.
- After primary evaluation if final diagnosis could not be made, and investigator still suspect acute appendicitis, participant is included in to randomised study part.
- Randomised sudy part has two arms: control and observation groups.
- Control group get the traditional diagnostic path - is refered to CT scan examination.
- Observation group get repeated evaluation after 8-12 hours and only than is diagnosis stays unclear, patient gets a CT scan.
- All patient are contacted after 30 days after visit to our hospital, to get information about their health status and possible additional visits to other hospitals or operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with the symptoms of acute appendicitis: pain in the right lower quadrant, pain migration from epigastrium to right lower quadrant, nausea, rebound pain, elevated temperature.
排除标准
- •for randomized part:
- •Pregnant patient.
- •Inclusion Criteria for randomized part:
- •After primary clinical, laboratory and ultrasound examination diagnosis of acute appendicitis could not be confirmed or excluded.
- •No other gynecological, urological ir gastroenterological pathology is confirmed.
- •Exclusion Criteria for randomized part:
- •Clinical symptoms lasts for longer than 48 hours
- •Signs of peritonitis
研究组 & 干预措施
Control
Patient gets usual diagnostic path: after inconclusive ultrasound is refered to CT scan.
Observation
Patient after inconclusive primary evaluation is observed in emergency room for 8-12 hours and after the clinical evaluation, laboratory results and ultrasound examination is repeated.
干预措施: Observation (Procedure)
结局指标
主要结局
Negative appendectomy rate
时间窗: 30 days
We expect the negative appendectomy rate will will not increase while using alternative diagnostic protocol that includes patient observation.
Reduction of the CT scans number
时间窗: 24 hours
when performing alternative diagnostic protocol, that includes patient observation for short period we expect to reduce a number of CT scans performed, for the patients with suspected acute appendicitis.
次要结局
- 'Appendicitis Inflammatory Response (AIR) Score'(12 hours)
- Delta marker White blood cell count(12 hours)
- Delta marker CRP count(12 hours)
- Delta marker Alvarado acute appendicitis risk evaluation score(12 hours)
- Delta marker changes in ultrasound results(12 hours)
研究者
Tomas Poskus
Profesor at Vilnius University
Vilnius University