NCT02811926

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,019

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

Same day

First QC Date

May 30, 2016

Last Update Submit

October 16, 2017

Conditions

ColostomyIleostomy - StomaEnterostomy

Keywords

parastomal bulgingperistomal bulgingileostomycolostomyenterostomyincidencerisk factor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Ileostomy or colostomy

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subject is registered in the Danish Stoma Database Capital Region
  • Is registered as having either ileostomy, jejunostomy, sigmoidostomy, or transversostomy

You may not qualify if:

  • Patients with urostomy or unknown stoma type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD fellow

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 23, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share