Uncomplicated acute appendicitis
Conditions
Interventions
Antibiotics-alone group:Antibiotic therapy alone (intravenous plus oral regimen)
ERAT Group:ERAT plus Antibiotic Therapy
Sponsors
The Seventh Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Clinical signs of uncomplicated acute appendicitis, including migratory right lower quadrant pain or persistent right lower quadrant pain; 3.Imaging findings confirming uncomplicated acute appendicitis. All enrolled participants must have abdominal CT confirmation of uncomplicated acute appendicitis; ultrasound may be used as an initial screening tool; 4.Willing to participate in the study, provide written informed consent, and accept random allocation to ERAT or antibiotic treatment;
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation; 2.Complicated acute appendicitis suggested by imaging, e.g., perforation, periappendiceal abscess or localized fluid collection, free intraperitoneal air, obvious ascites, diffuse peritonitis, extensive inflammation, or involvement of adjacent organs; 3.Non-first episode of acute appendicitis; 4.Severe uncontrolled comorbidity or immunosuppressive condition, e.g., decompensated heart, lung, liver, or renal insufficiency, long-term systemic corticosteroid or other immunosuppressive therapy, active malignancy or malignancy requiring systemic treatment, severe psychiatric disorder, or inability to cooperate with study assessments; 5.Active inflammatory bowel disease requiring treatment; 6.Contraindication to bowel preparation or colonoscopy, such as intestinal obstruction or obvious intestinal paralysis, toxic megacolon, severe sepsis, shock or hemodynamic instability, gastrointestinal perforation, acute severe gastrointestinal inflammation, significant coagulation abnormality, or recent use of strong anticoagulant or antiplatelet therapy that cannot be discontinued; 7.Imaging suspicion of malignant lesions, such as appendiceal, cecal, or colorectal tumors, or suspected peritoneal metastasis; 8.Symptom duration >72 hours from onset to enrollment assessment; 9.Other baseline infection, such as pneumonia or urinary tract infection, requiring antibiotics other than those specified in the study protocol; 10.Concurrent illness that would otherwise mandate hospitalization outside of appendicitis and associated symptoms at baseline/screening; 11.Anatomical abnormality on imaging or preoperative assessment that makes ERAT unsuitable, such as fistula formation between the appendix and ileum or colon, markedly enlarged appendiceal orifice, giant appendicolith with a maximum diameter >2 cm, or other conditions deemed unsuitable for ERAT by the investigator; 12.Current participation in another interventional clinical trial involving investigational drugs, devices, or procedural therapy; 13.Any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year treatment success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-intervention complications;Recurrence rate of appendicitis within one year;Time to recurrence of appendicitis;Length of hospital stay (days);Time to return to daily activities or work (days);Analgesic use;Direct hospital costs;Duration and dose of antibiotic use;Pain score;Health-related quality of life;Time to sustained pain relief;Sick leave duration (days);Patient satisfaction; | — |
Countries
China
Contacts
Public ContactWei Wei
The Seventh Affiliated Hospital Sun Yat-sen University
Outcome results
None listed