One Versus Five Days of Antibiotics After Appendectomy for Straightforward Acute Appendicitis: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of Surgical Site Infection (SSI)
研究概览
简要总结
The goal of this clinical trial is to learn if a one-day course of antibiotics after appendectomy surgery works as well as a five-day course to prevent infections in children and adults (aged 10 years and older) with uncomplicated acute appendicitis (non-ruptured, non-gangrenous appendix). The main questions it aims to answer are:
- Does a one-day antibiotic regimen result in a similar rate of surgical site infections, intra-abdominal abscesses, or death within 30 days after surgery compared to a five-day regimen?
- What is the rate of hospital readmission, antibiotic-related side effects, and cost-effectiveness for each treatment duration?
Researchers will compare participants receiving 24 hours of intravenous antibiotics to participants receiving 5 days of antibiotics (1 day intravenous followed by 4 days oral) to see if the shorter course is non-inferior (not meaningfully worse) to the longer standard course.
Participants will:
- Undergo appendectomy for uncomplicated acute appendicitis
- Be randomly assigned to receive either one day or five days of postoperative antibiotics
- Receive follow-up at 30 days after surgery, including a telephone call to check for infections, readmissions, or other complications
- Allow study staff to collect information from their medical records regarding hospital stay, antibiotic side effects, and any need for reoperation or restarting antibiotics
详细描述
Background and Rationale
Acute appendicitis remains one of the most common indications for emergency abdominal surgery worldwide. While perioperative prophylactic antibiotics are universally recommended for appendectomy, the optimal duration of postoperative antibiotic therapy for uncomplicated (non-perforated, non-gangrenous) acute appendicitis remains poorly defined. Current clinical practice varies widely, with some surgeons prescribing no postoperative antibiotics, others recommending 24 hours of therapy, and many continuing a traditional five- to seven-day course. This variation persists despite growing evidence that prolonged antibiotic exposure may offer no additional clinical benefit while increasing the risks of antimicrobial resistance, adverse drug events, Clostridioides difficile infection, and healthcare costs.
Antimicrobial resistance has been declared a top global public health threat by the World Health Organization, with estimates suggesting 10 million annual deaths attributable to AMR by 2050. Surgical specialties, including general surgery, have been identified as high-priority targets for antimicrobial stewardship interventions due to historically high rates of antibiotic prescribing. Shortening postoperative antibiotic courses when clinically appropriate represents a key stewardship strategy that can reduce selective pressure on resistant organisms while maintaining or improving patient outcomes.
Study Objectives
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
no other parties are masked
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥10 years.
- •Undergoing appendectomy with intraoperative diagnosis of straightforward acute appendicitis ( non-phlegmonous, non-gangrenous, non-perforated, no abscess).
排除标准
- •Complex appendicitis (gangrenous, perforated, abscess).
- •Severe sepsis at presentation.
- •Immunocompromised state ( including diabetic patients ).
- •Pregnancy.
- •Allergy to study antibiotics.
- •Concurrent infections requiring antibiotics.
研究组 & 干预措施
a one day (24 hours) post operative antibiotic
• Short course (guideline course): 24 hours of postoperative IV antibiotics (ampicillin/sulbactam)
干预措施: a single day (24 hours) post operative (Drug)
a five day post operative antibiotic
• Standard course (current applicable course): 1days of postoperative IV antibiotics (amoxicillin /clavulanic acid) followed by 4 days of oral antibiotic (amoxicillin /clavulanic acid).
干预措施: a single day (24 hours) post operative (Drug)
结局指标
主要结局
Rate of Surgical Site Infection (SSI)
时间窗: Within 30 days post-appendectomy
The proportion of participants diagnosed with a surgical site infection (superficial incisional, deep incisional, or organ/space) within 30 days following appendectomy. Diagnosis will be based on CDC criteria.
Rates of Intra-abdominal Abscess (IAA)
时间窗: Within 30 days (± 3 days) post-appendectomy.
The proportion of participants diagnosed with an intra-abdominal abscess.
Rate of All-Cause Mortality
时间窗: Within 30 days post-appendectomy
The proportion of participants who die from any cause within 30 days following appendectomy.
次要结局
- Rate of Hospital Readmission(Within 30 days post-appendectomy)
研究者
Shaimaa Abdullah Sayed Ali Gebili
head of clinical research department
Ministry of Health and Population, Egypt