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.
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)
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
Parallel
Postoperative antibiotico-prophylaxis
DrugPatients receive oral antibiotics following surgery for perforated appendicitis. The dose, duration, and type are at the discretion of the treating physician.
No postoperative antibiotics
Other interventionPatients do not receive antibiotics following surgery for perforated appendicitis.
Average number of participants enrolled per month across multiple sites.
Assessment of accrual: feasible if 10 or more overall.
Percentage of participants who receive the correct intervention.
Assessment of ability to accurately deliver the intervention that participants were randomized to receive: feasible if \>90% of participants receive the assigned intervention.
Percentage of patient-reported outcomes collected.
Assessment of ability to collect complete data for patient reported outcomes. Feasible if \>80% of data is collected directly from patients with an additional 10% collected from patient health records.
Quality of Life, as assessed by EQ-5D-5L.
Level Sum Score can be calculated, ranging from 5 to 25, with higher scores representing a worse health status.
Post-operative pain, as assessed by PROMIS Pain Inventory.
5-point Likert scale, with higher scores (i.e., 5 or "very much") indicating higher levels of pain.
Percentage of patients with surgical site infections, as assessed by Participant Assessment of Surgical Wound questionnaire.
5 questions (4 yes/no answers, 1 check all that apply).
Percentage of participants prescribed systemic antibiotics.
Collected from Participant Assessment of Surgical Wound questionnaire or patient health records.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
