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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02811926

Enrollment

5019

Registered

2016-06-23

Start date

2016-07-31

Completion date

2016-07-31

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colostomy, Enterostomy, Ileostomy - Stoma

Keywords

parastomal bulging, peristomal bulging, ileostomy, colostomy, enterostomy, incidence, risk factor

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results