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

Completed

• Conditions: Colostomy; Enterostomy; Ileostomy - Stoma

• Registration Number: NCT02811926
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Study Timeline

• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Study Start: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5019

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with the incidence of parastomal bulging	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.