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

Ileostomy - Stoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02811926
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase N/A
Start date July 2016
Completion date July 2016
View Details
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