Perforated AppendicitisPAPA PilotNCT07656636
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
A study testing Postoperative antibiotico-prophylaxis and No postoperative antibiotics in people with Perforated Appendicitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Postoperative antibiotico-prophylaxis and No postoperative antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Perforated Appendicitis
- Being tested
- Postoperative antibiotico-prophylaxis, No postoperative antibiotics
- Keywords
- Perforated appendicitis, Complicated appendicitis, Postoperative antibiotics, Randomized controlled trial, Pilot trial, Acute care surgery, Emergency general surgery
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative antibiotico-prophylaxisDrug
Patients receive oral antibiotics following surgery for perforated appendicitis. The dose, duration, and type are at the discretion of the treating physician.
No postoperative antibioticsOther
Patients do not receive antibiotics following surgery for perforated appendicitis.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative antibiotics | Active comparator | Patients receive antibiotics following surgery for perforated appendicitis. Receives: Drug: Postoperative antibiotico-prophylaxis |
| No postoperative antibiotics | Active comparator | Patients do not receive antibiotics following surgery for perforated appendicitis. Receives: Other: No postoperative antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of participants enrolled per month across multiple sites.
Assessment of accrual: feasible if 10 or more overall.
Measured: 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.
Measured: 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.
Measured: 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.
Level Sum Score can be calculated, ranging from 5 to 25, with higher scores representing a worse health status.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Within 90 days after surgery for perforated appendicitis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Kelly Vogt, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656636
- Sponsor's protocol ID
- 5867
- Acronym
- PAPA Pilot
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
- ClinicalTrials.gov ID
- NCT07656636
- Acronym / sponsor ID
- PAPA Pilot / 5867
- Conditions
- Perforated Appendicitis
- Keywords
- Perforated appendicitis, Complicated appendicitis, Postoperative antibiotics, Randomized controlled trial, Pilot trial, Acute care surgery, Emergency general surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative antibiotics | Active comparator | Drug: Postoperative antibiotico-prophylaxisPatients receive antibiotics following surgery for perforated appendicitis. |
| No postoperative antibiotics | Active comparator | Other: No postoperative antibioticsPatients do not receive antibiotics following surgery for perforated appendicitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative antibiotico-prophylaxisPatients receive oral antibiotics following surgery for perforated appendicitis. The dose, duration, and type are at the discretion of the treating physician. | Drug | Postoperative antibiotics |
| No postoperative antibioticsPatients do not receive antibiotics following surgery for perforated appendicitis. | Other | No postoperative antibiotics |
Primary outcome
Average number of participants enrolled per month across multiple sites.
Time frame: First to last day of each month of recruitment phase (1 year).
Assessment of accrual: feasible if 10 or more overall.
Percentage of participants who receive the correct intervention.
Time frame: From beginning to end of recruitment phase (1 year).
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.
Time frame: Duration of the study (1 year). For each participant, data collected 30 and 90 days after surgery.
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.
6 secondary outcomes
Quality of Life, as assessed by EQ-5D-5L.
Time frame: 30 and 90 days after surgery for perforated appendicitis.
Post-operative pain, as assessed by PROMIS Pain Inventory.
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.
Time frame: 30 days after surgery for perforated appendicitis.
Percentage of participants prescribed systemic antibiotics.
Time frame: Within 30 days after surgery for perforated appendicitis.
Post-operative complications, as assessed by Health Resource Utilization questionnaire.
Time frame: Within 90 days after surgery for perforated appendicitis.
Healthcare utilization, as assessed by Health Resource Utilization questionnaire.
Time frame: Within 90 days after surgery for perforated appendicitis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative antibiotico-prophylaxis and No postoperative antibiotics in people with Perforated Appendicitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of participants enrolled per month across multiple sites. (time frame: First to last day of each month of recruitment phase (1 year).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.