A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
研究概览
简要总结
The overall project goal is to conduct a pilot randomized clinical trial of operative (laparoscopic appendectomy) vs nonoperative (antibiotic) management of uncomplicated acute appendicitis for vulnerable populations. Specifically, the elderly, non-English speakers, and those with economic vulnerability (low socioeconomic status and/or manual labor jobs without a non-weight lifting aspect), are three vulnerable population subsets identified. This pilot trial will provide critical preliminary data for planning and conducting a larger multi-site randomized trial.
详细描述
The study would involve consented subjects, once confirmed eligible to proceed after screening, will be randomly assigned to two arms:
- Group 1 - Operative Group - Operation will be performed to remove appendix.
- Group 2 - Non-operative group - No operation will be performed, and instead the subject will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics, for treatment of appendicitis.
Aside from the routine hospital care, participants will be asked to fill out a survey for cognitive function (CAM Assessment Form), pain (Visual Analog Scale), and quality of life at the start and end of participant's hospital stay, 1-2 weeks after discharge, and again at 6 weeks after discharge from the initial hospital visit.
Participants will also be asked to participate in a qualitative interview, either by virtual visit, site visit, or phone call, at 1-2 weeks and again at about 6 weeks after discharge from the hospital. Each interview will be approximately 20-30 minutes of the participant's time.
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
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
- •Age ≥18 years
- •Able to consent for the study
- •Diagnosis of acute appendicitis confirmed by CT imaging
排除标准
- •Appendicolith/fecalith on imaging
- •Chronic or recurrent appendicitis
- •Having received prior antibiotic treatment for other reasons within 5 days prior to study enrollment
- •Hemodynamically abnormal (SBP<90 mmHg, Heart Rate (HR) >120, mmHg, Partial Pressure of Oxygen in Arterial Blood (PaO2<60), or potential of Hydrogen (pH<7.3)).
- •Inability to tolerate general anesthesia (determined by surgery and anesthesiology teams)
研究组 & 干预措施
Operative Arm
Operation (laparoscopic appendectomy) will be performed to remove appendix.
干预措施: Laparoscopic appendectomy (Procedure)
Non-Operative Arm
No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics
干预措施: Antibiotics (IV transitioned to oral) (Drug)
结局指标
主要结局
Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
时间窗: 12 months post treatment
Feasibility of the intervention is measured by the proportion of enrolled participants who are randomized and retained in this study
Feasibility of the intervention as measured by the number of complications or adverse events
时间窗: 12 months post treatment
Feasibility of the intervention is measured by the number of complications or adverse events encountered by participants while enrolled in this study
次要结局
- Feasibility of the intervention as measured by QoL surveys(6 weeks post-discharge)
- Change in pain score from baseline as measured by visual analog pain scale at 6 weeks post discharge(Baseline, 6 weeks post discharge)
- Feasibility of the intervention as measured by hospital costs for each enrolled participant (Antibiotics Group)(the day of discharge (approx. 1-3 days post treatment))
- Change in pain score from baseline as measured by visual analog pain scale at prior to discharge home (approx. 4-6 hours post treatment)(Baseline, prior to discharge home (approx. 4-6 hours post treatment))
- Change in cognitive function as measured by CAM assessment form at 1-2 weeks post discharge(Baseline, 1-2 weeks post discharge)
- Feasibility of the intervention as measured by total length of hospital stay (Operative Group)(the day of discharge (approx. 0-2 days post treatment))
- Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits(6 weeks post-discharge)
- Change in pain score from baseline as measured by visual analog pain scale at 1-2 weeks post discharge(Baseline, 1-2 weeks post discharge)
- Feasibility of the intervention as measured by hospital costs for each enrolled participant (Operative Group)(the day of discharge (approx. 0-2 days post treatment))
- Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)(the day of discharge (approx. 1-3 days post treatment))
- Change in cognitive function as measured by CAM assessment form at 6 weeks post discharge(Baseline, 6 weeks post discharge)
- Feasibility of the intervention as measured by physical function using FRAIL scale(Baseline)
研究者
Sneha Bhat
ASSISTANT PROFESSOR - Surgery
University of Texas Southwestern Medical Center