Perforated Appendicitis and Postoperative Antibiotics Pilot Trial

NCT07656636 | Not Yet Recruiting

• 1 other identifier: 5867
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perforated Appendicitis

Keywords

Perforated appendicitis; Complicated appendicitis; Postoperative antibiotics; Randomized controlled trial; Pilot trial; Acute care surgery; Emergency general surgery

Outcome Measures

Primary Outcomes (3)

• Average number of participants enrolled per month across multiple sites.

  Assessment of accrual: feasible if 10 or more overall.

  First to last day of each month of recruitment phase (1 year).

• 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.

  From beginning to end of recruitment phase (1 year).

• 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.

  Duration of the study (1 year). For each participant, data collected 30 and 90 days after surgery.

Secondary Outcomes (6)

• Quality of Life, as assessed by EQ-5D-5L.

  30 and 90 days after surgery for perforated appendicitis.

• Post-operative pain, as assessed by PROMIS Pain Inventory.

  30 days after surgery for perforated appendicitis.

• Percentage of patients with surgical site infections, as assessed by Participant Assessment of Surgical Wound questionnaire.

  30 days after surgery for perforated appendicitis.

• Percentage of participants prescribed systemic antibiotics.

  Within 30 days after surgery for perforated appendicitis.

• Post-operative complications, as assessed by Health Resource Utilization questionnaire.

  Within 90 days after surgery for perforated appendicitis.

Study Arms (2)

Postoperative antibiotics

ACTIVE COMPARATOR

Patients receive antibiotics following surgery for perforated appendicitis.

Drug: Postoperative antibiotico-prophylaxis

No postoperative antibiotics

ACTIVE COMPARATOR

Patients do not receive antibiotics following surgery for perforated appendicitis.

Other: No postoperative antibiotics

Interventions

Postoperative antibiotico-prophylaxis DRUG

Patients receive oral antibiotics following surgery for perforated appendicitis. The dose, duration, and type are at the discretion of the treating physician.

Postoperative antibiotics

No postoperative antibiotics OTHER

Patients do not receive antibiotics following surgery for perforated appendicitis.

No postoperative antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Sunnybrook Health Sciences Centre: collaborator

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Surgery

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06