NCT02811926

Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy

Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy: a Register-based Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,019 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to use routinely-collected health data from registers to examine the incidence of parastomal bulging (PB) at different time points in the first year after surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk factors for development of PB.

Detailed description

Parastomal bulging (PB) in patients with ileostomy and colostomy in the Capital Region of Denmark up to one year after surgery is the primary outcome in this study. The investigators will use a register-based study design to evaluate routinely-collected health data from the Danish Stoma Database Capital Region (DSDCR). Incidence of PB one year post surgery and at different points of follow-up during the first year will be investigated using survival analysis. Potential risk factors will be investigated controlling for potential confounders. In order to include relevant variables on lifestyle, comorbidity, and physical status, data from the DSDCR will be linked to data from the Danish Anaesthesia Database.

Conditions

• Colostomy
• Ileostomy - Stoma
• Enterostomy

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-06-23
• Last updated: 2017-10-18