Acute AppendicitisNCT06834958
Clinical Diagnosis of Acute Appendicitis with Normal WBCS Count with Role of Inflammatory Markers and Radiology
An observational study of Acute Appendicitis, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to describe the proportion of pa-tients with normal preoperative inflammatorymarkers among patients with histopathologically proven acute appendicitis Read more about this study
- Who is it for?
- Ages 14 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to Oct 2028
- Phase
- Observational
- 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 14 to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study not need special type of people
Who may be able to join
- Male or female patients é clinically diagnosed acute appendicitis with normal WBCS
Who cannot join
- complicated AA (perforation, peri appendicular abscess or suspicion of a tumor.
- 2inflammatory bowel diseases 3inability to co-operate and give informed consent 4diffuse peritonitis 5Patients with serious comorbid conditions DM \& renal insufficiency, serum creatinine > 150 μmol/l 6Pregnant \& lactating patient 7Patients with advanced malignancies \& pt on immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to describe the proportion of pa-tients with normal preoperative inflammatorymarkers among patients with histopathologically proven acute appendicitis
Read the detailed description
2.4.1- Type of the study: prospective clinical trial study 2.4. 2- Study Setting: Assuit university hospital 2.4. 3- Study subjects:
- Inclusion criteria: patients complain of Rt iliac pain with Us positive for acute appendicitis with WBCS normal .
- Exclusion criteria: malignant mass cancer appendix mesenteric adentis cecal diverticulum salpingitis c. Sample Size Calculation: 50 cases 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Lab WBCS count CRP level Neutrophil differential count Clinical correlation US findings and MSCT if needed
- Conditions
- Acute Appendicitis
- Being tested
- Appendectomy
- Keywords
- Clinical diagnosis of 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.
AppendectomyProcedure or surgery
Open surgery for appendix which is inflamed
| Study group | Role | What they receive |
|---|---|---|
| Patient included who have acute appendicitis clinically and normal WBCS count | Not described Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery done if needed
Patient with acute appendicitis and normal WBCS count will be under observation for while but people with evidence on imaging and high inflammatory markers will go under surgery
Measured: Days of hospital reservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jan 2025
- Primary completion1 Oct 2027 (estimated)
- Study completionOct 2028 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Kotb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834958
- Sponsor's protocol ID
- Clinical diagnosis of acute ap
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Diagnosis of Acute Appendicitis with Normal WBCS Count with Role of Inflammatory Markers and Radiology
- ClinicalTrials.gov ID
- NCT06834958
- Acronym / sponsor ID
- Clinical diagnosis of acute ap
- Conditions
- Acute Appendicitis
- Keywords
- Clinical diagnosis of acute appendicitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 19 Feb 2025 (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 describe the proportion of pa-tients with normal preoperative inflammatorymarkers among patients with histopathologically proven acute appendicitis
Detailed description
2.4.1- Type of the study: prospective clinical trial study 2.4. 2- Study Setting: Assuit university hospital 2.4. 3- Study subjects:
- Inclusion criteria: patients complain of Rt iliac pain with Us positive for acute appendicitis with WBCS normal .
- Exclusion criteria: malignant mass cancer appendix mesenteric adentis cecal diverticulum salpingitis c. Sample Size Calculation: 50 cases 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Lab WBCS count CRP level Neutrophil differential count Clinical correlation US findings and MSCT if needed
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient included who have acute appendicitis clinically and normal WBCS count | – | Procedure: Appendectomy |
Who may qualify
- Ages
- 14 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study not need special type of people
Key inclusion criteria (1 listed)
- Male or female patients é clinically diagnosed acute appendicitis with normal WBCS
Key exclusion criteria (2 listed)
- complicated AA (perforation, peri appendicular abscess or suspicion of a tumor.
- 2inflammatory bowel diseases 3inability to co-operate and give informed consent 4diffuse peritonitis 5Patients with serious comorbid conditions DM \& renal insufficiency, serum creatinine > 150 μmol/l 6Pregnant \& lactating patient 7Patients with advanced malignancies \& pt on immunosuppressive drugs
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 |
|---|---|---|
| AppendectomyOpen surgery for appendix which is inflamed | Procedure or surgery | Patient included who have acute appendicitis clinically and normal WBCS count |
Primary outcome
Surgery done if needed
Time frame: Days of hospital reservation
Patient with acute appendicitis and normal WBCS count will be under observation for while but people with evidence on imaging and high inflammatory markers will go under surgery
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 19 Feb 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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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?
An observational study of Acute Appendicitis, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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 19 Feb 2025. 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 Egypt. 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?
Surgery done if needed (time frame: Days of hospital reservation). 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 19 Feb 2025.