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NCT02811926 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT02811926
Other study ID # 15018151
Secondary ID
Status Completed
Phase N/A
First received May 30, 2016
Last updated October 16, 2017
Start date July 2016
Est. completion date July 2016

Study information
Verified date October 2017
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 5019
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Herlev Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with the incidence of parastomal bulging 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. Up to 1 year after primary surgery
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