Comparison of Antibiotic Therapy and Surgery in the Management of Acute Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Treatment success of the initial management strategy
研究概览
简要总结
The aim of this study is to identify clinical, laboratory, and imaging parameters that can predict the most appropriate treatment strategy in patients diagnosed with acute appendicitis. Although appendectomy remains the gold standard treatment, selected patients may be successfully treated with antibiotic therapy. Therefore, determining which patients are more likely to benefit from surgical treatment and which may be managed with antibiotics represents an important clinical challenge.
This study is designed as a single-center prospective observational study. Patients aged 18 years and older who are diagnosed with acute appendicitis between 2024 and 2025 will be included. Demographic characteristics, diagnostic modalities, laboratory parameters, clinical scoring systems (Ohmann score and Alvarado score), imaging findings, and treatment modality (antibiotic therapy or appendectomy) will be prospectively recorded.
Patients treated with antibiotics will be followed to determine whether appendectomy becomes necessary later and to evaluate the time interval between diagnosis and surgery. Patients with other causes of acute abdomen or those with incomplete clinical data will be excluded from the study.
The primary aim of the study is to determine parameters that can predict treatment selection and clinical outcomes. Sensitivity, specificity, and predictive values of the evaluated parameters will be calculated to assess their usefulness in guiding treatment decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Diagnosis of acute appendicitis
- •Patients managed either with antibiotic therapy or appendectomy
- •Availability of clinical, laboratory, and imaging data
排除标准
- •Age <18 years
- •Presence of another cause of acute abdomen (e.g., ovarian torsion, gastrointestinal perforation, etc.)
- •Patients who did not receive either antibiotic therapy or surgical treatment (treatment refusal)
- •Patients hospitalized for another primary medical condition
- •Patients receiving antibiotics for another infection at the time of diagnosis
- •Incomplete or inaccessible clinical data
结局指标
主要结局
Treatment success of the initial management strategy
时间窗: Up to 1 years follow-up
Treatment success is defined as the proportion (%) of patients who achieve resolution of acute appendicitis without the need for additional surgical or interventional procedures during the follow-up period. For patients treated with antibiotics, success is defined as the resolution of clinical symptoms (abdominal pain, fever), normalization of inflammatory markers (white blood cell count, C-reactive protein), and no requirement for appendectomy. For patients treated with appendectomy, success is defined as the completion of surgery without major postoperative complications (Clavien-Dindo grade ≥ III) and no need for reintervention.
次要结局
- Need for delayed appendectomy(Up to 1 years)
研究者
Sebahattin Celik MD
Professor
Yuzuncu Yil University