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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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comparatore attivo: No postoperative antibiotics
Patients do not receive antibiotics following surgery for perforated appendicitis.
Patients do not receive antibiotics following surgery for perforated appendicitis.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Average number of participants enrolled per month across multiple sites.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life, as assessed by EQ-5D-5L.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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