Acute appendicitis
Conditions
Interventions
Single-Dose Antibiotic Group:Pre-operative: Ceftriaxone sodium for injection (2 g dissolved in 100 mL of 0.9% NaCl solution for intravenous infusion) + Leonoxazole disodium phosphate for injection (1
treatment to be discontinued within 24 hours
Multiple-Dose Antibiotic Group:Pre-operative: Ceftriaxone sodium for injection (2 g dissolved in 100 mL of 0.9% NaCl solution for intravenous infusion) + Leonoxazole disodium phosphate for injection (
treatment to be discontinued within 24 hours.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and 10?/L d) Body temperature > 38.5°C e) Most recent C-reactive protein (CRP) > 10 mg/L; 4.Imaging-confirmed (preferably ultrasound; CT or MRI as alternatives) acute uncomplicated appendicitis with at least one of the following features: a) Appendiceal diameter > 6 mm b) Appendiceal wall thickening with contrast enhancement on CT, or marked luminal dilation without wall thickening c) Periappendiceal inflammatory edema and minimal fluid collection d) On ultrasound at the point of maximal tenderness: concentric, layered, non-compressible sausage-like structure e) On ultrasound: partial or complete loss, or enlargement, of the hyperechoic submucosal layer f) On ultrasound: increased echogenicity of periappendiceal fat, possibly with increased fat vascularity; 5.American Society of Anesthesiologists (ASA) physical status class I or II. 6.The patient or an authorized family member agrees to participate and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1.Imaging-confirmed appendiceal abscess or perforation; 2.Imaging-confirmed soft tissue mass of the appendix suspicious for appendiceal neoplasm. 3.Diagnosis of diffuse peritonitis. 4.Known allergy or previous adverse reaction to levoornidazole or cephalosporins. 5.Receipt of at least two doses of antibiotic therapy prior to current admission. 6.Active infectious disease other than appendicitis requiring systemic anti-infective therapy. 7.Diagnosis of septic shock according to Sepsis-3 criteria. 8.Suspected or confirmed inflammatory bowel disease (IBD). 9.Suspected tuberculosis or history of tuberculosis. 10.Presence of surgical implants (e.g., left ventricular assist device, peritoneal dialysis catheter). 11.Any contraindication to surgery. 12.Severe peripheral or central nervous system disease or history of epilepsy. 13.Severe chronic liver disease with Child-Pugh class C. 14.Serum creatinine >= 176.8 µmol/L. 15.Pregnancy, planned pregnancy within 3 months, or breastfeeding. 16.Hematopoietic dysfunction: hemoglobin = 4 (male) or >= 3 (female), or average daily pure alcohol intake > 40 g (male) / 20 g (female) within the last 6 months, or clinical evidence of alcohol dependence. 18.Severe systemic disease or serious comorbidity requiring hospitalization (e.g., cardiopulmonary dysfunction, immunodeficiency, malignancy receiving chemotherapy). 19.Participation in another clinical trial within 6 months before study initiation. 20.Severe cardiovascular, cerebrovascular, psychiatric, or metabolic disorders. 21.Inability to comply with the study protocol or follow-up schedule due to personal (e.g., hearing, visual, speech impairment), family, or geographic reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical site infection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate;Medical costs and length of hospital stay;Pathogen distribution; | — |
Countries
China
Contacts
Public ContactZheng Tao
Shanghai General Hospital
Outcome results
None listed