Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative antibiotico-prophylaxis, No postoperative antibiotics.
- Who it may be relevant to
- Registry conditions: Perforated Appendicitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Postoperative antibiotico-prophylaxis
Patients receive oral antibiotics following surgery for perforated appendicitis. The dose, duration, and type are at the discretion of the treating physician. - Other No postoperative antibiotics
Patients do not receive antibiotics following surgery for perforated appendicitis.
Primary outcome measures
- Average number of participants enrolled per month across multiple sites. [Time frame: First to last day of each month of recruitment phase (1 year).]
- Percentage of participants who receive the correct intervention. [Time frame: From beginning to end of recruitment phase (1 year).]
- 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.]
Secondary outcome measures (6)
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07656636 · 5867