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 randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,800
Patient receives antibiotics while waiting appendectomy
No antibiotics are given while waiting surgery.
Patients can wait up to 8 hours for surgery.
HUS, Jorvi Hospital
Espoo, Finland
HUS, Meilahti Hospital
Helsinki, Finland
Complicated appendicitis
Surgical finding is complicated appendicitis (AAST Grade III-V)
Time frame: during surgery
Time of hospital stay
Time in hours from randomization to discharge from hospital
Time frame: 30 days from surgery
Postoperative complications
complications are defined according to Clavien-Dindo classification
Time frame: 30 days from surgery
Pain measured by numeric rating scale while waiting surgery
Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain.
Time frame: up to 36 hours
Surgical site infections (SSI) and positive blood cultures
SSIs classified according to CDC classification: superficial incisional, deep incisional and organ/space infection. Blood cultures are obtained if patient has fever over 38.5 degrees Celcius.
Time frame: within 30 days from randomization
Conversions of laparoscopic surgeries to open surgery
All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation.
Time frame: during the the first operation for acute appendicitis
Gangrenous or perforated appendicitis according to pathological examination.
All specimens are sent to pathological examination and all pathological reports are reviewed
Time frame: 3 week after surgery
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Patients can wait up to 24 hours for surgery.
Sunshine Appendicitis Grading System Score classification
Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome
Time frame: during surgery