The Swedish study of shortened antibiotic treatment after surgery for Pediatric Acute Perforated Appendicitis; a randomized controlled non-inferiority study (RCT) comparing 3 versus 5 days of postoperative antibiotics.

Condition studied

Paediatric Acute Perforated Appendicitis - postoperative treatment

Investigational medicinal product(s)

Every trial of Clindamycin and Ciprofloxacin across our registers →

Eligibility

Primary endpoint

Postoperative infectious complications within 30 days after surgery for APA (Intraabdominal abscess, Wound infection, Other?)

Endpoint detail

Complications according to Clavien Madadi within 30 days of surgery., Reoperations or radiological interventions within 30 days and reasons for re-intervention (drainage of abscess, surgery for intestinal obstruction etc)., Readmissions within 30 days and reasons for that (infection, pain, other), Total length of stay in hospital after surgery for APA., Total number of adverse reactions to antibiotic treatment (allergic reaction or other) and differences between groups?, Number of participants in the study population with a need for prolonged antibiotics and distribution between treatment groups? This will be regarded as a composite endpoint., Total length of antibiotic treatment (per protocol) and number of individuals who have restarted antibiotic treatment within 30 days after surgery., Reason for prolonged antibiotic treatment in cases where there is prolonged antibiotic treatment?, Type and number of postoperative imaging studies, Type and number of surgical or radiological re-interventions., Time (days) to return to preschool/school/work (child/parent) in total and with 3 compared to 5 days of postoperative antibiotics?, Pre-operative risk factors such as: a, long duration of symptoms before surgery, b, age, c, gender, d, CRP>135 and e,low S-Na and correlation to postoperative complications?, Peri-operative risk factors such as f, time from arrival at emergency department to surgery (hours), g, time for surgery (hours), h, method of surgery, (laparoscopy/converted/open), i, appearance appendix at time of surgery and j, leakage of feces in abdomen correlated to postoperative complications after surgery for APA?, Post-operative risk factors such as: k, level of leucocytes and l, CRP at day 3 and correlation to postoperative complications after surgery for APA be identified?