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

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.

Completed

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Key information

Conditions

Colostomy Enterostomy Ileostomy - Stoma

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

Herlev Hospital

Registry information

Official study title

Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy: a Register-based Study

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jun 23, 2016
Registry last updated: Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed