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Not yet recruiting NCT06828952

Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis

— Observational Conservative Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ceftriaxone, ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly.
Who it may be relevant to
Registry conditions: Conservative Management. Basic parameters: 16 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug ceftriaxone
    ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
  • Drug ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly
    Conservative management

Primary outcome measures

  • Risk factors of failure of conservative treatment in acute non complicated appendicitis [Time frame: One year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University — Asyut

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. PMID 19936849
  • 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. PMID 24263678
  • 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. PMID 31560305
  • 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. PMID 29146455
  • 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. PMID 27826565

Identifiers

NCT: NCT06828952 · acute appendicitis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗