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

NCT ID: NCT06828952

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-22

Study Completion Date

2025-12-02

Brief Summary

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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

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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

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Conservative Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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(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

Intervention Type DRUG

ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

Intervention Type DRUG

Conservative management

Interventions

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ceftriaxone

ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

Intervention Type DRUG

ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

Conservative management

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role collaborator

Ahmed Mohammed Hussein Sayed

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohammed Hussein Sayed

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Mohammed Hussein Sayed Ahmed Razeen, MBBCh

Role: CONTACT

+2001099414358

Mohamed Taher Gamal Amin Taher, MBBCh &MD &PHD

Role: CONTACT

+2001091289046

References

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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.

Reference Type BACKGROUND
PMID: 19936849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24263678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31560305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29146455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27826565 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/19936849/

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 scor

Other Identifiers

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acute appendicitis

Identifier Type: -

Identifier Source: org_study_id

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