Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy
|ClinicalTrials.gov Identifier: NCT02811926|
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):
Rune Martens Andersen, Rigshospitalet, Denmark
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.
|Condition or disease|
|Colostomy Ileostomy - Stoma Enterostomy|
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 Type :||Observational|
|Actual Enrollment :||5019 participants|
|Official Title:||Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy: a Register-based Study|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Ileostomy or colostomy
Patients with a ileostomy or colostomy in the Capital Region of Denmark
Primary Outcome Measures :
- Number of patients with the incidence of parastomal bulging [ Time Frame: Up to 1 year after primary surgery ]Parastomal bulging evaluated by stoma care nurses through symptoms, visual inspection, and stomal exploration. Parastomal bulging is evaluated at scheduled visits at stoma care clinics on postoperative days 30, 90, 180, and 365, and at any additional visits inbetween.
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