Antibiotics vs Surgery in Acute Appendicitis

NCT07492329 | Active Not Recruiting DMC

• 1 other identifier: 2024-050674
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis

Keywords

Acute Appendicitis; Non-operative management of acute appendicitis; Prediction of treatment strategy in acute appendicitis

Outcome Measures

Primary Outcomes (1)

• Treatment success of the initial management strategy

  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 Outcomes (1)

• Need for delayed appendectomy

  Up to 1 years

Study Arms (2)

Antibiotic Therapy

ACTIVE COMPARATOR

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

Drug: Antibiotic

Appendectomy

ACTIVE COMPARATOR

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

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

Interventions

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

Surgical appendectomy performed according to clinical guidelines

Appendectomy

Antibiotic DRUG

Antibiotic therapy administered for the treatment of acute appendicitis according to current clinical guidelines.

Antibiotic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sebahattin Celik MD: lead

Study Sites (1)

Health Sciences University, Van Education and Research Hospital

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Surgical Procedures, Operative; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 25, 2026
• Study Start: November 4, 2024
• Primary Completion: November 4, 2025
• Study Completion (Estimated): November 4, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)