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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34269
• EU PAS number:
  EUPAS16564
• Study ID:
  34269
• Official title and acronym:
  Incidence of Surgical Site Infections After Lower Gastrointestinal Surgery in Patients With Crohn’s Disease or Ulcerative Colitis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a non-interventional retrospective cohort study. The drug being tested in this study is called vedolizumab. This study will look at the incidence of surgical site infections (SSI) after a lower GI surgery in patients with CD or UC, and determine if it varies by type of inflammatory bowel disease (IBD) therapy. Participants will be identified for participation in the study through Optum Clinformatics Data Mart, which is a database managed by the United States started in May 2000. Participants who have CD or UC and underwent a major lower GI surgery after 01 September 2014 will be identified from the database. Participants will be assessed for infections such as postoperative wound infection, peritonitis, retroperitoneal infection, and sepsis occurring 2-30 days after the lower GI surgery.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 20/12/2016

Actual: 20/12/2016

Study start date

Planned: 20/12/2016

Actual: 20/12/2016

Data analysis start date

Planned: 20/01/2017

Actual: 30/09/2017

Date of final study report

Planned: 31/12/2017

Actual: 30/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Ltd

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable