An interventional study of Postoperative antibiotico-prophylaxis and No postoperative antibiotics in Perforated Appendicitis, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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:
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:
Acute appendicitis, a sudden and severe inflammation of the appendix, is the most common emergency general surgery condition worldwide. In some cases, the appendix perforates, leading to contamination or infection within the abdominal cavity. Complicated appendicitis is associated with higher morbidity and mortality, including a higher risk of surgical site infections (SSIs). Approximately 20% of patients with complicated appendicitis develop an SSI, compared to about 5% of patients with uncomplicated appendicitis.
The use of antibiotics before surgery is well established and standard practice to reduce SSI risk. However, there is limited evidence to guide the use of antibiotics after surgery in patients with complicated appendicitis. Antibiotics carry potential risks, including allergic reactions, gastrointestinal side effects, and secondary infections, and their overuse contributes to antimicrobial resistance, which is a growing global health concern. As a result, there is a considerable variation in clinical practice, with some surgeons routinely prescribing post-operative antibiotics and others choosing not to.
Large, high-quality randomized controlled trials (RCTs), the gold-standard in clinical research, are needed to understand if post-operative antibiotics are necessary in this population. The current study will evaluate the impact of post-operative antibiotics on SSIs in patients with perforated appendicitis. This pilot specifically aims to determine the feasibility of a larger, multi-centre RCT, and will assess our ability to enroll and randomize patients, and to collect complete health data using an existing framework. Patients will be randomly assigned to receive post-operative antibiotics or no post-operative antibiotics after surgery for perforated appendicitis, and will be followed until 30 days after surgery to assess incidence of SSIs, with additional outcomes collected up to 90 days post-surgery.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 100 is close to the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive antibiotics following surgery for perforated appendicitis.
Drug: Postoperative antibiotico-prophylaxis
Patients do not receive antibiotics following surgery for perforated appendicitis.
Other: No postoperative antibiotics
Patients receive oral antibiotics following surgery for perforated appendicitis. The dose, duration, and type are at the discretion of the treating physician.
Patients 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of the study (1 year). For each participant, data collected 30 and 90 days after surgery.
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.
Time frame: 30 and 90 days after surgery for perforated appendicitis.
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.
Time frame: 30 days after surgery for perforated appendicitis.
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).
Time frame: 30 days after surgery for perforated appendicitis.
Percentage of participants prescribed systemic antibiotics.
Collected from Participant Assessment of Surgical Wound questionnaire or patient health records.
Time frame: Within 30 days after surgery for perforated appendicitis.
Post-operative complications, as assessed by Health Resource Utilization questionnaire.
6 questions (5 yes/no, 1 check all that apply).
Time frame: Within 90 days after surgery for perforated appendicitis.
Healthcare utilization, as assessed by Health Resource Utilization questionnaire.
Healthcare utilization, including number of: reinterventions, all-cause reoperations, emergency department visits, all-cause unplanned family physician or walk-in clinic visits, and all-cause readmissions and length of stay of each readmission.
Time frame: Within 90 days after surgery for perforated appendicitis.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's →