Conservative ManagementappendicitisNCT06828952
Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis
An observational study of Conservative Management, run by Ahmed Mohammed Hussein Sayed at 1 site in Egypt.
Trial summary
From this study, it can be concluded that patients who meet the following criteria are more likely to fail expectant management and thus should not be considered for the NOM of uncomplicated acute appendicitis. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Conservative Management
- What is being tested?
- ceftriaxone and ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2025to 2 Dec 2025
- How long will I take part?
- 2 Days
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Male or female patients é diagnosis of acute appendicitis Patients with ages: from 16 to 60 years old
Who may be able to join
- Male or female patients é diagnosis of acute appendicitis .
- Patients with ages: from 16 to 60 years old.
Who cannot join
- complicated AA (appendicolith, perforation, peri appendicular abscess or suspicion of a tumor).
- inflammatory bowel disease.
- inability to co-operate and give informed consent.
- diffuse peritonitis.
- antibiotic documented allergy \& allergy to contrast media .
- Patients with serious comorbid conditions DM \& renal insufficiency, serum creatinine > 150 μmol/l .
Show all 11Show fewer
- Pregnant \& lactating patient.
- Patients with bleeding diathesis and those on anticoagulants.
- Patients with advanced malignancies \& patient on immunosuppressive drugs .
- Patients with previous appendectomy.
- Extreme of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
From this study, it can be concluded that patients who meet the following criteria are more likely to fail expectant management and thus should not be considered for the NOM of uncomplicated acute appendicitis. These include the duration of symptoms before presenting to a surgical emergency , the presence of fever within 24 hours of presenting to a surgical emergency, TLC cells/dL, CRP mg/L, appendix diameter mm, modified Alvarado score , and adult appendicitis score .
Read the detailed description
Expectant management with intravenous antibiotic therapy alone has emerged as an effective alternative to appendectomy for the treatment of uncomplicated acute appendicitis . It is important to identify patients at the onset of the disease who are likely to have successful outcomes for conservative management.
- Conditions
- Conservative Management
- Being tested
- ceftriaxone, ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
- Keywords
- Appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourlyDrug
Conservative management
| Study group | Role | What they receive |
|---|---|---|
| (1) Male or female patients é diagnosis of acute appendicitis. | Patients who presented with complaints of right lower quadrant pain with symptoms and signs strongly suggestive of uncomplicated acute appendicitis that was confirmed on ultrasonography, were included. The modified Alvarado score and adult appendicitis score were calculated. Receives: Drug: ceftriaxone; Drug: ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors of failure of conservative treatment in acute non complicated appendicitis
modified Alvarado score and adult appendicitis score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start22 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Conservative ManagementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ahmed Mohammed Hussein Sayed
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Ahmed Mohammed Hussein Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828952
- Sponsor's protocol ID
- acute appendicitis
- Acronym
- appendicitis
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shindoh J, Niwa H, Kawai K, Ohata K, Ishihara Y, Takabayashi N, Kobayashi R, Hiramatsu T. Predictive factors for negative outcomes in initial non-operative management of suspected appendicitis. J Gastrointest Surg. 2010 Feb;14(2):309-14. doi: 10.1007/s11605-009-1094-1.
PubMed 19936849Hansson J, Khorram-Manesh A, Alwindawe A, Lundholm K. A model to select patients who may benefit from antibiotic therapy as the first line treatment of acute appendicitis at high probability. J Gastrointest Surg. 2014 May;18(5):961-7. doi: 10.1007/s11605-013-2413-0. Epub 2013 Nov 22.
PubMed 24263678Walker C, Moosavi A, Young K, Fluck M, Torres D, Widom K, Wild J. Factors Associated with Failure of Nonoperative Management for Complicated Appendicitis. Am Surg. 2019 Aug 1;85(8):865-870.
PubMed 31560305Loftus TJ, Brakenridge SC, Croft CA, Stephen Smith R, Efron PA, Moore FA, Mohr AM, Jordan JR. Successful nonoperative management of uncomplicated appendicitis: predictors and outcomes. J Surg Res. 2018 Feb;222:212-218.e2. doi: 10.1016/j.jss.2017.10.006. Epub 2017 Nov 13.
PubMed 29146455Cervellin G, Mora R, Ticinesi A, Meschi T, Comelli I, Catena F, Lippi G. Epidemiology and outcomes of acute abdominal pain in a large urban Emergency Department: retrospective analysis of 5,340 cases. Ann Transl Med. 2016 Oct;4(19):362. doi: 10.21037/atm.2016.09.10.
PubMed 27826565
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis
- ClinicalTrials.gov ID
- NCT06828952
- Acronym / sponsor ID
- appendicitis / acute appendicitis
- Conditions
- Conservative Management
- Keywords
- Appendicitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahmed Mohammed Hussein SayedUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 22 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 17 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.
From this study, it can be concluded that patients who meet the following criteria are more likely to fail expectant management and thus should not be considered for the NOM of uncomplicated acute appendicitis. These include the duration of symptoms before presenting to a surgical emergency , the presence of fever within 24 hours of presenting to a surgical emergency, TLC cells/dL, CRP mg/L, appendix diameter mm, modified Alvarado score , and adult appendicitis score .
Detailed description
Expectant management with intravenous antibiotic therapy alone has emerged as an effective alternative to appendectomy for the treatment of uncomplicated acute appendicitis . It is important to identify patients at the onset of the disease who are likely to have successful outcomes for conservative management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (1) Male or female patients é diagnosis of acute appendicitis. | – | Drug: ceftriaxone, Drug: ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourlyPatients who presented with complaints of right lower quadrant pain with symptoms and signs strongly suggestive of uncomplicated acute appendicitis that was confirmed on ultrasonography, were included. The modified Alvarado score and adult appendicitis score were calculated. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Male or female patients é diagnosis of acute appendicitis Patients with ages: from 16 to 60 years old
Key inclusion criteria (2 listed)
- Male or female patients é diagnosis of acute appendicitis .
- Patients with ages: from 16 to 60 years old.
Key exclusion criteria (11 listed)
- complicated AA (appendicolith, perforation, peri appendicular abscess or suspicion of a tumor).
- inflammatory bowel disease.
- inability to co-operate and give informed consent.
- diffuse peritonitis.
- antibiotic documented allergy \& allergy to contrast media .
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 |
|---|---|---|
| ceftriaxoneceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly | Drug | (1) Male or female patients é diagnosis of acute appendicitis. |
| ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourlyConservative management | Drug | (1) Male or female patients é diagnosis of acute appendicitis. |
Primary outcome
Risk factors of failure of conservative treatment in acute non complicated appendicitis
Time frame: One year
modified Alvarado score and adult appendicitis score
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 17 Feb 2025.
- Background: PubMed 19936849Shindoh J, Niwa H, Kawai K, Ohata K, Ishihara Y, Takabayashi N, Kobayashi R, Hiramatsu T. Predictive factors for negative outcomes in initial non-operative management of suspected appendicitis. J Gastrointest Surg. 2010 Feb;14(2):309-14. doi: 10.1007/s11605-009-1094-1.
- Background: PubMed 24263678Hansson J, Khorram-Manesh A, Alwindawe A, Lundholm K. A model to select patients who may benefit from antibiotic therapy as the first line treatment of acute appendicitis at high probability. J Gastrointest Surg. 2014 May;18(5):961-7. doi: 10.1007/s11605-013-2413-0. Epub 2013 Nov 22.
- Background: PubMed 31560305Walker C, Moosavi A, Young K, Fluck M, Torres D, Widom K, Wild J. Factors Associated with Failure of Nonoperative Management for Complicated Appendicitis. Am Surg. 2019 Aug 1;85(8):865-870.
- Background: PubMed 29146455Loftus TJ, Brakenridge SC, Croft CA, Stephen Smith R, Efron PA, Moore FA, Mohr AM, Jordan JR. Successful nonoperative management of uncomplicated appendicitis: predictors and outcomes. J Surg Res. 2018 Feb;222:212-218.e2. doi: 10.1016/j.jss.2017.10.006. Epub 2017 Nov 13.
- Background: PubMed 27826565Cervellin G, Mora R, Ticinesi A, Meschi T, Comelli I, Catena F, Lippi G. Epidemiology and outcomes of acute abdominal pain in a large urban Emergency Department: retrospective analysis of 5,340 cases. Ann Transl Med. 2016 Oct;4(19):362. doi: 10.21037/atm.2016.09.10.
- include the duration of symptoms before presenting to a surgical emergency , the presence of fever within 24 hours of presenting to a surgical emergency, TLC cells/dL, CRP mg/L, appendix diameter mm, modified Alvarado score , and adult appendicitis scorLink provided by the sponsor.
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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.
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 Conservative Management, run by Ahmed Mohammed Hussein Sayed 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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 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?
Contact Ahmed Mohammed Hussein Sayed Ahmed Razeen, MBBCh (+2001099414358, Ahmed.16266245@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors of failure of conservative treatment in acute non complicated appendicitis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06828952, which also lists 5 linked publications.
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 17 Feb 2025.