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

October 16, 2017 updated by: Rune Martens Andersen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an ileostomy or colostomy in the Danish Stoma Database Capital Region

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Ileostomy or colostomy
Patients with a ileostomy or colostomy in the Capital Region of Denmark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year after primary surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15018151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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