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

• 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
• 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

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）：几乎十分之一的人经历阑尾炎，一种称为阑尾的肠道小部分发炎和疼痛的疾病。通常的治疗是住院和全身麻醉和手术切除阑尾。人们需要大约两周的时间才能恢复。阑尾炎的病因尚不完全清楚。一种解释是，阑尾变得阻塞，导致膨胀和不可逆转的血流缺乏，因此需要手术切除治愈。另一种解释是阑尾炎是由于感染，这表明抗生素也可能有效。以前的非美国研究表明，许多患者可以用抗生素而不是阑尾切除术治疗，多达70%的患者避免了手术，并且通常疼痛更少，恢复更快。然而，由于这些研究涉及的患者太少，并且没有使用理想的方法，医生目前没有提供这种选择。我们的总体目标是进行第一次 美国一项大型试验，以确定抗生素治疗是否是手术的安全有效的替代方案。 我们的主要目的是证明抗生素治疗产生的患者结果并不比阑尾切除术差。这一目标将通过进行一项大型试验来实现，在该试验中，阑尾炎患者被随机分配接受抗生素治疗或手术治疗，并测试以下假设：最初接受抗生素治疗的患者在30天内不会比接受阑尾切除术治疗的患者出现更多的严重并发症。次要目的是比较这些结果和其他以患者为中心的结果，如疼痛持续时间和恢复正常活动的时间，为期两年。我们还将进行研究，以进一步探索阑尾炎的原因，包括查看患者基因以确定谁有患病风险，检查阑尾炎组织的微生物学，并测试血液化学物质，称为生物标志物，这可能有助于确定哪些患者最有可能对抗生素作出反应。在全面试验之前，我们建议对30名受试者进行试点调查，以证明进行全面试验的可行性。这将是一项关键的临床试验，将增加患者的选择，并为那些没有准备好接受手术治疗的服务不足者提供安全的选择，同时普遍提高患者的健康，满意度和生产力，并推进我们对疾病的科学理解。

项目成果

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

In reply.

回复。

• DOI: 10.3949/ccjm.81c.12002
• 发表时间: 2014
• 期刊: Cleveland Clinic journal of medicine
• 影响因子: 6.1
• 作者: ChingSun,GraceE;Kashyap,SangeetaR;Nasr,Christian
• 通讯作者: Nasr,Christian