- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06828952
Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis (appendicitis)
February 13, 2025 updated by: Ahmed Mohammed Hussein Sayed
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 .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed Mohammed Hussein Sayed Ahmed Razeen, MBBCh
- Phone Number: +2001099414358
- Email: Ahmed.16266245@med.aun.edu.eg
Study Contact Backup
- Name: Mohamed Taher Gamal Amin Taher, MBBCh &MD &PHD
- Phone Number: +2001091289046
- Email: mohamedamin022@aun.edu.eg
Study Locations
-
-
-
Assuit, Egypt, 71515
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Male or female patients é diagnosis of acute appendicitis Patients with ages: from 16 to 60 years old
Description
Inclusion Criteria:
- Male or female patients é diagnosis of acute appendicitis .
- Patients with ages: from 16 to 60 years old.
Exclusion Criteria:
- 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 .
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
(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.
|
ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
Conservative management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors of failure of conservative treatment in acute non complicated appendicitis
Time Frame: One year
|
modified Alvarado score and adult appendicitis score
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cervellin 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.
- 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.
- Hansson 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.
- Walker 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.
- Loftus 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 22, 2025
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 2, 2025
Study Registration Dates
First Submitted
December 4, 2024
First Submitted That Met QC Criteria
February 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 13, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Intestinal Diseases
- Infections
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Cecal Diseases
- Intraabdominal Infections
- Appendicitis
- Third Generation Cephalosporins
- Beta Lactam Antibiotics
- Anti-Bacterial Agents
- Anti-Infective Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Ceftriaxone
- Metronidazole
Other Study ID Numbers
- acute appendicitis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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