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

NCT06828952 | Not Yet Recruiting

• 1 other identifier: acute appendicitis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Conservative Management

Keywords

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Risk factors of failure of conservative treatment in acute non complicated appendicitis

  modified Alvarado score and adult appendicitis score

  One year

Study Arms (1)

(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.

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

Interventions

ceftriaxone DRUG

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

(1) Male or female patients é diagnosis of acute appendicitis.

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

Conservative management

(1) Male or female patients é diagnosis of acute appendicitis.

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Male or female patients é diagnosis of acute appendicitis .
• Patients with ages: from 16 to 60 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed Mohammed Hussein Sayed: lead
• Assiut University: collaborator

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Appendicitis

Interventions

Ceftriaxone; Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ahmed Mohammed Hussein Sayed Ahmed Razeen, MBBCh

CONTACT

+2001099414358; Ahmed.16266245@med.aun.edu.eg

Mohamed Taher Gamal Amin Taher, MBBCh &MD &PHD

CONTACT

+2001091289046; mohamedamin022@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: February 17, 2025
• Study Start: June 22, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 2, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-12

Locations

EG (1)