Antibiotics vs Surgery in Acute Appendicitis

Sebahattin Celik MD

Status: Active, not recruiting

Conditions: Acute Appendicitis

Treatments: Drug: Antibiotic; Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT07492329

2024-050674

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Diagnosis of acute appendicitis
• Patients managed either with antibiotic therapy or appendectomy
• Availability of clinical, laboratory, and imaging data

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Antibiotic Therapy

Active Comparator group

Description:

Patients with acute appendicitis treated with antibiotic therapy without immediate appendectomy.

Treatment:

Drug: Antibiotic

Appendectomy

Active Comparator group

Description:

Patients diagnosed with acute appendicitis who undergo surgical appendectomy as the primary treatment.

Treatment:

Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines