Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a...

Area of Science:

• Surgical Oncology
• Infectious Diseases
• Pharmacology

Background:

• Acute appendicitis is a common surgical emergency.
• Prolonged antibiotic prophylaxis is standard for complex appendicitis post-appendectomy, but optimal duration is debated.
• Increasing antimicrobial resistance necessitates optimizing antibiotic strategies.

Purpose of the Study:

• To determine if a short course (48 hours) of postoperative antibiotics is non-inferior to the standard 5-day course for complex appendicitis.
• To evaluate the impact of shorter antibiotic durations on infectious complications and antimicrobial resistance.

Main Methods:

• 1066 patients aged 8+ undergoing appendectomy for complex appendicitis were randomized.
• One group received 48 hours of IV antibiotics; the control group received 5 days.
• Primary outcome: composite of infectious complications (intra-abdominal abscess, surgical site infection) and mortality within 90 days.

Main Results:

• The study is designed to establish non-inferiority of the 48-hour antibiotic course.
• A non-inferiority margin of 7.5% for the primary endpoint rate is set.
• Both per-protocol and intention-to-treat analyses will be performed.

Conclusions:

• This trial will provide evidence on the non-inferiority of 48-hour versus 5-day postoperative antibiotic courses.
• If non-inferiority is shown, current guidelines for extended antibiotic administration may need adjustment.
• This could lead to reduced antibiotic use in appendectomy for complex appendicitis.