Appendicitis
Conditions
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 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.
Interventions
DRUGAntibiotics, cefuroxime and metronidazole
Patient receives antibiotics while waiting appendectomy
DRUGNo antibiotics
No antibiotics are given while waiting surgery.
OTHERurgent schedule
Patients can wait up to 8 hours for surgery.
OTHERless urgent schedule
Patients can wait up to 24 hours for surgery.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomized into two arms according to urgency and simultaneously each patient is randomized into two arms according to antibiotic treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complicated appendicitis | during surgery | Surgical finding is complicated appendicitis (AAST Grade III-V) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of hospital stay | 30 days from surgery | Time in hours from randomization to discharge from hospital |
| Postoperative complications | 30 days from surgery | complications are defined according to Clavien-Dindo classification |
| Pain measured by numeric rating scale while waiting surgery | up to 36 hours | Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain. |
| Surgical site infections (SSI) and positive blood cultures | within 30 days from randomization | 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. |
| Conversions of laparoscopic surgeries to open surgery | during the the first operation for acute appendicitis | All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation. |
| Gangrenous or perforated appendicitis according to pathological examination. | 3 week after surgery | All specimens are sent to pathological examination and all pathological reports are reviewed |
| Sunshine Appendicitis Grading System Score classification | during surgery | Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome |
Countries
Finland
Outcome results
None listed