Acute AppendicitisNCT07492329
Antibiotics vs Surgery in Acute Appendicitis
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines and Antibiotic in people with Acute Appendicitis, run by Sebahattin Celik MD at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines and Antibiotic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2024to 4 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of acute appendicitis
- Patients managed either with antibiotic therapy or appendectomy
- Availability of clinical, laboratory, and imaging data
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University, Van Education and Research Hospital
Van
About this study
Official title: 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.
Read more
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
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Antibiotic
- Keywords
- Acute Appendicitis, Non-operative management of acute appendicitis, Prediction of treatment strategy in acute appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesProcedure or surgery
Surgical appendectomy performed according to clinical guidelines
AntibioticDrug
Antibiotic therapy administered for the treatment of acute appendicitis according to current clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Therapy | Active comparator | Patients with acute appendicitis treated with antibiotic therapy without immediate appendectomy. Receives: Drug: Antibiotic |
| Appendectomy | Active comparator | Patients diagnosed with acute appendicitis who undergo surgical appendectomy as the primary treatment. Receives: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 years follow-up
Secondary outcomes (1)
Need for delayed appendectomy
Proportion of patients initially treated with antibiotics who subsequently require appendectomy.
Measured: Up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start4 Nov 2024
- Primary completion4 Nov 2025
- Study completion4 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebahattin Celik MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sebahattin Celik MD, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492329
- Sponsor's protocol ID
- 2024-050674
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antibiotic Therapy and Surgery in the Management of Acute Appendicitis
- ClinicalTrials.gov ID
- NCT07492329
- Acronym / sponsor ID
- 2024-050674
- Conditions
- Acute Appendicitis
- Keywords
- Acute Appendicitis, Non-operative management of acute appendicitis, Prediction of treatment strategy in acute appendicitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sebahattin Celik MDUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Therapy | Active comparator | Drug: AntibioticPatients with acute appendicitis treated with antibiotic therapy without immediate appendectomy. |
| Appendectomy | Active comparator | Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesPatients diagnosed with acute appendicitis who undergo surgical appendectomy as the primary treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Diagnosis of acute appendicitis
- Patients managed either with antibiotic therapy or appendectomy
- Availability of clinical, laboratory, and imaging data
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesSurgical appendectomy performed according to clinical guidelines | Procedure or surgery | Appendectomy |
| AntibioticAntibiotic therapy administered for the treatment of acute appendicitis according to current clinical guidelines. | Drug | Antibiotic Therapy |
Primary outcome
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.
1 secondary outcome
Need for delayed appendectomy
Time frame: Up to 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines and Antibiotic in people with Acute Appendicitis, run by Sebahattin Celik MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success of the initial management strategy (time frame: Up to 1 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.