Role of delay and antibiotics on PERForation rate while waiting appendECTomy

Phase 1

• Conditions: Acute appendicitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-002348-26-NO
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-10
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Diagnosed acute appendicitis, in which laparoscopic appendectomy is planned. Diagnosis should be confirmed either by high Adult Appendicitis Score (16 or over) or by diagnostic imaging including computed tomography (CT), ultrasound or magnetic resonance imaging (MRI). All patients with symptoms over three days should undergo CT or MRI before inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Complicated appendicitis based on imaging studies. These include following findings:
a. extraluminal air or extraluminal fecalith
b. fluid collection, abscess or phlegmon around appendix
c. nonenhancing appendices wall on contrast enhanced imaging
2. Likely complicated appendix based on laparatory testing defined by plasma C-reactive protein (P-CRP) 100 mg/l or over.
3. Fever measured on emergency department over 38.5 degrees Celsius
4. Clinical diffuse peritonitis or other reason , which may indicate immediate surgery.
5. Pregnancy
6. Age below 18 years
7. Missing written informed consent
8. Allergy to cefalosporins or metronidazole or anaphylaxis after penicillin-group antibiotics
9. Ongoing antibiotic treatment
10. Patient is known carrier of resistant bacterial strain such as ESBL E.Coli

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified