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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02811926
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : October 18, 2017
Herlev Hospital
Information provided by (Responsible Party):
Rune Martens Andersen, 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.

Condition or disease
Colostomy Ileostomy - Stoma Enterostomy

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.

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Study Type : Observational
Actual Enrollment : 5019 participants
Observational Model: Other
Time Perspective: Retrospective
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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an ileostomy or colostomy in the Danish Stoma Database Capital Region

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
Additional Information:
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Responsible Party: Rune Martens Andersen, PhD fellow, Rigshospitalet, Denmark Identifier: NCT02811926    
Other Study ID Numbers: 15018151
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rune Martens Andersen, Rigshospitalet, Denmark:
parastomal bulging
peristomal bulging
risk factor