Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of Participants With Pulmonary Complications
研究概览
简要总结
This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.
详细描述
As the novel coronavirus disease 2019 (COVID-19) disseminates across the United States, more routine preoperative testing is going to expose infected patients with no or mild pneumonia symptoms. Currently, little is known regarding the true consequences of general anesthesia in COVID-positive (COVID+) patients. Surgeons are going to face challenging decisions regarding whether or not to operate for non-elective cases requiring general anesthesia when non-operative treatment options exist. Patients with acute appendicitis are usually treated with an operation to remove the appendix, but they can also be initially treated with antibiotics and have an operation at a later date. Similarly, patients with acute cholecystitis are usually treated with an operation to remove the gallbladder, but they can be treated with antibiotics and a percutaneous cholecystostomy tube (a tube that going through the skin to drain the gallbladder) and have an operation at a later date. However, patients managed without a definitive operation may require more resource utilization, PPE consumption, interactions with hospital personnel, and could experience treatment failures that exacerbate their viral illness. This is a pilot study comparing the safety of operative versus non-operative management of COVID+ patients with mild to moderate symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be informed regarding the treatment they receive at the time of randomization.
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
- •COVID-19 confirmed positive by a microbiologic test.
- •Mild COVID-19 - no or mild pneumonia
- •Uncomplicated acute appendicitis without a fecalith OR
- •Acute cholecystitis - by TG18/TG13 diagnostic criteria where definite diagnosis requires one item in A + one item in B + C A. Local signs of inflammation etc.
- •Murphy's sign
- •RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
- •elevated CRP
- •elevated WBC count C. Imaging findings characteristic of acute cholecystitis
排除标准
- •Active pregnancy
- •COVID-19 severe disease that would be a contraindication to operative intervention at the discretion of the attending surgeon supported by the following, none of which are individually required or are a strict exclusion criterion as some of these could be attributed or exacerbated by the underlying surgical problem:
- •Persistent dyspnea
- •Persistent respiratory frequency >30/min
- •Persistent blood oxygen saturation <93%
- •Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
- •Lung infiltrates >50%
- •COVID-19 critical disease - respiratory failure, shock, or multiorgan dysfunction
- •The surgeon expects increased operative complexity - high risk of conversion to open or prolonged procedure
- •Unable or unwilling to consent or fulfill study procedures - need to complete 90 day follow-up by telephone
结局指标
主要结局
Number of Participants With Pulmonary Complications
时间窗: Up to 90 days
Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation For operative management this means any episode of non-invasive ventilation, invasive ventilation, or extracorporeal membrane oxygenation after initial extubation after surgery, or patient cannot be extubated as planned after surgery. For non-operative management this means any intubation
次要结局
- Mortality (All Cause)(Up to 90 days)
- Median Length of Hospital Stay(Up to 90 days)
- Number of Participants With Post-intervention ICU Admission(Up to 90 days)
- Number of Emergency Room Visits/Readmission(Up to 90 days)
- Complications as Measured by the Clavien-Dindo Classification(Up to 90 days)
研究者
Clayton Petro
Principal Investigator
The Cleveland Clinic