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

Rigshospitalet

Status: Completed

Conditions: Enterostomy; Ileostomy - Stoma; Colostomy

Study type: Observational

Funder types: Other

Identifiers

NCT02811926

15018151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,019 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is registered in the Danish Stoma Database Capital Region
• Is registered as having either ileostomy, jejunostomy, sigmoidostomy, or transversostomy

Exclusion criteria

• Patients with urostomy or unknown stoma type

Trial design

5,019 participants in 1 patient group

Ileostomy or colostomy

Description:

Patients with a ileostomy or colostomy in the Capital Region of Denmark