Pilot Randomized Trial of Antibiotics vs Surgery for Treating Acute Appendicitis

抗生素与手术治疗急性阑尾炎的随机试验

基本信息

批准号：
8935768
负责人：
DAVID ANDREW TALAN
金额：
$ 12.23万
依托单位：
OLIVE VIEW-UCLA EDUCATION AND RES INST
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-30 至 2017-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8935768
关键词：
Acute Appendicitis Address American College of Surgeons Analgesics Antibiotic Therapy Antibiotics Appendectomy Appendicitis Applications Grants Biological Markers Blood Tests Blood flow Caring Chemicals Child Clinical Trials Colorectal Surgery Diet Disease Eligibility Determination Emergency Situation Evaluation Excision Exclusion Failure Family Frequencies General Anesthesia Genes Genomics Goals Health Health Care Costs Health Resources Hospitalization Image Individual Infection Intestines Investigation Lead Measures Medical Meta-Analysis Methods Microbiology Operative Surgical Procedures Outcome Outcome Study Pain Pathogenesis Pathologic Processes Patient-Focused Outcomes Patients Perforation Physicians Pilot Projects Productivity Quality of life Randomized Controlled Trials Recovery Regimen Risk Role Sample Size Societies Testing Time Tissues Work base cost disability disorder risk experience follow-up high risk novel operation pathogen programs public health relevance randomized trial satisfaction

项目摘要

DESCRIPTION (provided by applicant): Almost one in ten people experience appendicitis, a disease in which a small part of the intestine called the appendix becomes inflamed and painful. The usual treatment is hospitalization and general anesthesia and surgery to remove the appendix. It takes people about two weeks to recover. The cause of appendicitis is not entirely clear. One explanation is that the appendix becomes obstructed leading to distention and irreversible lack of blood flow, thus requiring surgical removal to cure. Another explanation is that appendicitis is due to infection, and this suggests that antibiotics may also be effective. Previous non-U.S. studies indicate that many patients can be treated with antibiotics instead of appendectomy, with as many as 70% avoiding surgery and generally experiencing less pain and faster recovery. However, because these studies involved too few patients and did not use ideal methods, doctors do not currently offer this option. Our overall goal is to conduct the first large U.S. trial to determine if antibiotic therapy is a safe and effective alternative to surgery. Our primary aim is to demonstrate that antibiotic treatment produces patient outcomes that are no worse than appendectomy. This aim will be accomplished by conducting a large trial in which patients with appendicitis are assigned by chance to get antibiotics or surgery and testing the hypothesis that those treated initially with antibiotics will experience no more major complications at 30 days than those treated with appendectomy. Secondary aims will be to compare these and other patient-centered outcomes, like duration of pain and time to return to normal activities, over a two-year period. We will also conduct studies to further explore the cause of appendicitis including looking at patient genes to determine who is at risk of the disease, examining the microbiology of appendicitis tissue, and testing blood chemicals, called biomarkers, that may help determine which patients are most likely to respond to antibiotics. Prior to the full- scale trial, we propose a pilot investigation of 30 subjects to demonstrate the feasibility of conducting the full- scale trial. This will be a pivotal clinical trial that will inrease patient choice and provide a safe option for the underserved who do not have ready access to surgical care, while generally enhancing patient health, satisfaction, and productivity, and advancing our scientific understanding of the disease.

描述（由申请人提供）：几乎十分之一的人会经历阑尾炎，这种疾病在这种疾病中，其中一小部分被称为附录发炎和痛苦。通常的治疗方法是住院和全身麻醉和手术以删除附录。人们大约需要两个星期才能康复。阑尾炎的原因尚不完全清楚。一种解释是，附录被阻塞导致膨胀和不可逆转的血液流量缺乏，因此需要手术去除才能治愈。另一个解释是阑尾炎是由于感染引起的，这表明抗生素也可能有效。以前的非美国研究表明，许多患者可以接受抗生素而不是阑尾切除术治疗，多达70％避免手术，并且通常会疼痛和更快的康复速度。但是，由于这些研究涉及的患者太少并且没有使用理想的方法，因此医生目前尚未提供此选项。我们的总体目标是进行第一个美国大型试验确定抗生素治疗是否是手术的安全有效替代品。我们的主要目的是证明抗生素治疗产生的患者结局并不比阑尾切除术差。这一目标将通过进行大型试验来实现，在该试验中，阑尾炎的患者有机会获得抗生素或手术，并检验以下假设：那些最初接受抗生素治疗的人在30天后不会比接受阑尾切除术治疗的人更重大并发症。次要目标是比较这些和其他以患者为中心的结果，例如疼痛的持续时间以及在两年内恢复正常活动的时间。我们还将进行研究以进一步探索阑尾炎的原因，包括研究患者基因以确定谁有疾病的风险，检查阑尾炎组织的微生物学和测试称为生物标志物的血液化学物质，这些化学物质可能有助于确定哪些患者最有可能对抗生素有反应。在进行全尺度试验之前，我们建议对30名受试者进行试点调查，以证明进行全尺度试验的可行性。这将是一项关键的临床试验，它将为患者的选择而厌食，并为无法准备手术护理的服务欠缺的选择提供安全的选择，同时通常增强患者的健康，满意度和生产力，并提高我们对疾病的科学理解。

项目成果

期刊论文数量（3）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

DOI：
10.1016/j.annemergmed.2016.08.446
发表时间：
2017-07
期刊：
Annals of emergency medicine
影响因子：
6.2
作者：
Talan DA;Saltzman DJ;Mower WR;Krishnadasan A;Jude CM;Amii R;DeUgarte DA;Wu JX;Pathmarajah K;Morim A;Moran GJ;Olive View–UCLA Appendicitis Study Group
通讯作者：
Olive View–UCLA Appendicitis Study Group

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