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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5019 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Colostomy Ileostomy - Stoma Enterostomy

Keywords

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parastomal bulging peristomal bulging ileostomy colostomy enterostomy incidence risk factor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ileostomy or colostomy

Patients with a ileostomy or colostomy in the Capital Region of Denmark

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rune Martens Andersen

PhD fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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15018151

Identifier Type: -

Identifier Source: org_study_id