Clinical trial NCT06828952: Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis
Official title: Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Conservative Management
Keywords: Appendicitis
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2025-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk factors of failure of conservative treatment in acute non complicated appendicitis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assiut University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.