Status:
COMPLETED
Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are rand...
Eligibility Criteria
Inclusion
- Acute appendicitis where surgery is planned. Diagnosis of appendicitis should be verified either by clinical diagnosis with Adult Appendicitis Score \>=16 or by diagnostic imaging (CT-scan, MRI or ultrasound) showing appendicitis. All patients with symptoms at least 3 days should undergo diagnostic imaging before inclusion.
Exclusion
- Complicated appendicitis according to diagnostic imaging. The following findings indicate complicated appendicitis: extraluminal air or extraluminal fecalith; fluid collection, abscess or phlegmon next to appendix; non-enhancement appendiceal wall on contrast enhanced CT-scan.
- Plasma C-reactive protein \>=100
- Fever measured on emergency department over 38.5 degrees Celcius.
- Clinical generalized peritonitis or other reason that indicate immediate surgery
- Pregnancy, pregnancy test is taken from all fertile aged women before randomization
- Allergy to study antibiotics, or anaphylactic reaction after betalactam antibiotic or other contraindication for metronidazole or ongoing antibiotic treatment or patient is carrier of resistant bacteria. (This exclusion criteria are applicable only on randomization into antibiotic treatment arms)
- Missing written informed consent
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT04378868
Start Date
May 18 2020
End Date
February 23 2023
Last Update
July 11 2023
Active Locations (2)
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1
HUS, Jorvi Hospital
Espoo, Finland
2
HUS, Meilahti Hospital
Helsinki, Finland, 00029