- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07492329
Antibiotics vs Surgery in Acute Appendicitis
Comparison of Antibiotic Therapy and Surgery in the Management of Acute Appendicitis
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Van, Turkey (Türkiye)
- Health Sciences University, Van Education and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Antibiotic Therapy
Patients with acute appendicitis treated with antibiotic therapy without immediate appendectomy.
|
Antibiotic therapy administered for the treatment of acute appendicitis according to current clinical guidelines.
|
|
Active Comparator: Appendectomy
Patients diagnosed with acute appendicitis who undergo surgical appendectomy as the primary treatment.
|
Surgical appendectomy performed according to clinical guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment success of the initial management strategy
Time Frame: 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. |
Up to 1 years follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for delayed appendectomy
Time Frame: Up to 1 years
|
Proportion of patients initially treated with antibiotics who subsequently require appendectomy.
|
Up to 1 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-050674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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