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NCT07656636
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Conditions: Perforated Appendicitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
The goal of this clinical trial is to learn if not giving antibiotics is as effective as giving antibiotics after surgery for patients who have surgery for a perforated (burst) appendix. This pilot study will also help determine whether a larger, multi-centre study can be successfully conducted. The main questions it aims to answer are:
* Do patients who do not receive antibiotics after surgery have similar rates of infection after surgery as patients who do?
* Is it feasible to enroll and randomize patients and collect complete health data for a larger multi-centre study?
Researchers will compare patients who do not receive antibiotics after surgery to patients who do to see whether avoiding antibiotics is as effective as using antibiotics for preventing infections after surgery.
Participants will:
* Be randomly assigned to either receive or not receive antibiotics after surgery for their perforated (burst) appendix.
* Be contacted 30 and 90 days after surgery to check for infections and other health outcomes.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older
* Scheduled to undergo an open or laparoscopic appendectomy
* Complicated appendicitis confirmed intra-operatively (AAST Appendicitis Grade III or IV)
Exclusion Criteria:
* Patients demonstrating signs of septic shock for whom the omission of systemic antibiotics is contraindicated
* Patients with positive blood cultures for whom antibiotics are required for treatment of the bacteremia
* Immunosuppressed patients
* AAST Appendicitis Grade V
Source: ClinicalTrials.gov (NCT07656636). StuddyBuddy aggregates publicly available trial information.