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临床试验/NCT07656636
NCT07656636尚未招募不适用

Perforated Appendicitis and Postoperative Antibiotics Pilot Trial

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's0 个研究点目标入组 100 人开始时间: 2027年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100

研究概览

简要总结

The goal of this clinical trial is to learn if not giving antibiotics is as effective as giving antibiotics after surgery for patients who have surgery for a perforated (burst) appendix. This pilot study will also help determine whether a larger, multi-centre study can be successfully conducted. The main questions it aims to answer are:

  • Do patients who do not receive antibiotics after surgery have similar rates of infection after surgery as patients who do?
  • Is it feasible to enroll and randomize patients and collect complete health data for a larger multi-centre study?

Researchers will compare patients who do not receive antibiotics after surgery to patients who do to see whether avoiding antibiotics is as effective as using antibiotics for preventing infections after surgery.

Participants will:

  • Be randomly assigned to either receive or not receive antibiotics after surgery for their perforated (burst) appendix.
  • Be contacted 30 and 90 days after surgery to check for infections and other health outcomes.

详细描述

Acute appendicitis, a sudden and severe inflammation of the appendix, is the most common emergency general surgery condition worldwide. In some cases, the appendix perforates, leading to contamination or infection within the abdominal cavity. Complicated appendicitis is associated with higher morbidity and mortality, including a higher risk of surgical site infections (SSIs). Approximately 20% of patients with complicated appendicitis develop an SSI, compared to about 5% of patients with uncomplicated appendicitis.

The use of antibiotics before surgery is well established and standard practice to reduce SSI risk. However, there is limited evidence to guide the use of antibiotics after surgery in patients with complicated appendicitis. Antibiotics carry potential risks, including allergic reactions, gastrointestinal side effects, and secondary infections, and their overuse contributes to antimicrobial resistance, which is a growing global health concern. As a result, there is a considerable variation in clinical practice, with some surgeons routinely prescribing post-operative antibiotics and others choosing not to.

Large, high-quality randomized controlled trials (RCTs), the gold-standard in clinical research, are needed to understand if post-operative antibiotics are necessary in this population. The current study will evaluate the impact of post-operative antibiotics on SSIs in patients with perforated appendicitis. This pilot specifically aims to determine the feasibility of a larger, multi-centre RCT, and will assess our ability to enroll and randomize patients, and to collect complete health data using an existing framework. Patients will be randomly assigned to receive post-operative antibiotics or no post-operative antibiotics after surgery for perforated appendicitis, and will be followed until 30 days after surgery to assess incidence of SSIs, with additional outcomes collected up to 90 days post-surgery.

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

入选标准

  • Adults aged 18 years or older
  • Scheduled to undergo an open or laparoscopic appendectomy
  • Complicated appendicitis confirmed intra-operatively (AAST Appendicitis Grade III or IV)

排除标准

  • Patients demonstrating signs of septic shock for whom the omission of systemic antibiotics is contraindicated
  • Patients with positive blood cultures for whom antibiotics are required for treatment of the bacteremia
  • Immunosuppressed patients
  • AAST Appendicitis Grade V

研究组 & 干预措施

Postoperative antibiotics

Active Comparator

Patients receive antibiotics following surgery for perforated appendicitis.

干预措施: Postoperative antibiotico-prophylaxis (Drug)

No postoperative antibiotics

Active Comparator

Patients do not receive antibiotics following surgery for perforated appendicitis.

干预措施: No postoperative antibiotics (Other)

研究者

发起方
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Vogt

Associate Professor, Department of Surgery

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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