Incidence of Surgical Site Infections After Lower Gastrointestinal Surgery in Patients With Crohn’s Disease or Ulcerative Colitis

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Crohn's disease

  Colitis ulcerative

Population studied

• Short description of the study population:
  Adults with ulcerative colitis (UC) or Crohn’s disease (CD) who underwent lower gastrointestinal (GI) surgery of small intestine, colon, rectum, or anus during September 2014 to September 2016.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To quantify incidence of surgical site infections (SSI) after lower GI surgery in patients with UC or CD on non-biologic therapy, anti-tumor necrosis factor- alpha (TNF-alpha)/ustekinumab therapy, and vedolizumab therapy and to identify risk factors for SSIs after lower GI surgery in patients with UC or CD.
• Outcomes:
  Incidence of surgical site infections (SSI) occurring 2-30 days after the surgical procedure after 1 September 2014.
• Data analysis plan:
  Cumulative incidence (per 100 patients) of SSI will be calculated overall and for drug exposure categories (vedolizumab, anti-TNF-alpha anti-tumor necrosis factor- alpha/ustekinumab, and conventional therapy). A multivariate logistic regression model will be contructed to identify risk factors for an SSI, with the exposure reference group being conventional therapy. A stepwise regression will be used to fit covariates with a p<0.1 to enter a covariate and a p<0.05 to remain a covariate in the model.