Perforated Appendicitis and Postoperative Antibiotics Pilot Trial (PAPA Pilot)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Postoperative antibiotics
Patients receive antibiotics following surgery for perforated appendicitis.
|
Patients receive oral antibiotics following surgery for perforated appendicitis.
The dose, duration, and type are at the discretion of the treating physician.
|
|
Comparador Ativo: No postoperative antibiotics
Patients do not receive antibiotics following surgery for perforated appendicitis.
|
Patients do not receive antibiotics following surgery for perforated appendicitis.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Average number of participants enrolled per month across multiple sites.
Prazo: First to last day of each month of recruitment phase (1 year).
|
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.
Prazo: 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.
|
From beginning to end of recruitment phase (1 year).
|
|
Percentage of patient-reported outcomes collected.
Prazo: 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.
|
Duration of the study (1 year). For each participant, data collected 30 and 90 days after surgery.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of Life, as assessed by EQ-5D-5L.
Prazo: 30 and 90 days after surgery for perforated appendicitis.
|
Level Sum Score can be calculated, ranging from 5 to 25, with higher scores representing a worse health status.
|
30 and 90 days after surgery for perforated appendicitis.
|
|
Post-operative pain, as assessed by PROMIS Pain Inventory.
Prazo: 30 days after surgery for perforated appendicitis.
|
5-point Likert scale, with higher scores (i.e., 5 or "very much") indicating higher levels of pain.
|
30 days after surgery for perforated appendicitis.
|
|
Percentage of patients with surgical site infections, as assessed by Participant Assessment of Surgical Wound questionnaire.
Prazo: 30 days after surgery for perforated appendicitis.
|
5 questions (4 yes/no answers, 1 check all that apply).
|
30 days after surgery for perforated appendicitis.
|
|
Percentage of participants prescribed systemic antibiotics.
Prazo: Within 30 days after surgery for perforated appendicitis.
|
Collected from Participant Assessment of Surgical Wound questionnaire or patient health records.
|
Within 30 days after surgery for perforated appendicitis.
|
|
Post-operative complications, as assessed by Health Resource Utilization questionnaire.
Prazo: Within 90 days after surgery for perforated appendicitis.
|
6 questions (5 yes/no, 1 check all that apply).
|
Within 90 days after surgery for perforated appendicitis.
|
|
Healthcare utilization, as assessed by Health Resource Utilization questionnaire.
Prazo: Within 90 days after surgery for perforated appendicitis.
|
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.
|
Within 90 days after surgery for perforated appendicitis.
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 5867
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .