Role of delay and antibiotics on PERForation rate while waiting appendECTomy
- Conditions
- Acute appendicitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-002348-26-FI
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1800
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To find effect of preoperative delay and preoperative antibiotic treatment on rate of complicated appendicitis. Complicated appendicitis is defined by AAST Grade III-V.;Secondary Objective: Effect of preoperative antibiotics and delay on hospitalization, complications, pain during waiting surgery, surgical site infections and positive blood cultures, conversion during laparoscopic appendectomy, histopathological grade of appendicitis, degree of purulent fluid on abdomen (SAGS-classification);Primary end point(s): Number of patients with complicated appendicitis at surgery. Complicated appendicitis is defined by AAST Grade III-V.;Timepoint(s) of evaluation of this end point: During the appendectomy.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Hospitalization time in hours from randomization.<br>2. Complications within 30 days from operation, classified according to Clavien-Dindo classification.<br>3. Pain (Numeric Rating Scale) while waiting surgery<br>4. Surgical site infections ja positive blood cultures within 30 days from randomization.<br>5. Conversions of laparoscopic surgery to open<br>6. Gangrene of perforation in histological examination of appendix<br>7. Sunshine appendicitis grading system score differences;Timepoint(s) of evaluation of this end point: 1. at time of discharge<br>2. 30 days from surgery<br>3. every hour from randomization until to the beginning of the surgery<br>4. 30 days from randomization<br>5. at the end of surgery<br>6. 30 days from surgery<br>7. at the end of surgery