Quality of Life in Patients With and Without a Parastomal Bulge

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

1453 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-13

Study Completion Date

2018-12-31

Brief Summary

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It is not well-established whether a parastomal bulge impacts stoma patients HRQoL or if HRQOL differs according to the underlying disease or type of stoma. In this large cross-sectinal study stoma patients with and without a parastomal bulge are asked about their health-related quality of life and stomarelated quality of life. Stoma patients are identified in the danish stoma database and contacted two times by email. Non-responders are sent a paper booklet.

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Detailed Description

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A cross-sectional study of patients registered in the Danish Stoma Database Capital Region (DSDCR), with permanent or temporary enterostoma after surgery performed between 2011 and 2016. Via a unique personal identification number registered in DSDCR patients will be contacted by e-mail using the e-Boks system, an official electronic distribution system covering around 80% of the Danish adult population. The e-mail will contain information about the study and a personal link to SurveyXact, an online survey program allowing for direct electronic data entry by patients. First reminder will be sent after one week and a second reminder again one week later. If necessary, a third reminder additionally three weeks later will be sent to patients by post, including a paper booklet of the questionnaires as described below.

For patients without e-Boks, DSDCR will be linked to the Danish Civil Registration System via the unique personal identification number, providing information on patient's addresses. Information on the study and a paper booklet of questionnaires will be sent to patients by post. A reminder will be sent by post after three weeks if necessary. Hereafter, no further attempts will be made to contact the patients. To include other relevant variables in the analysis of data, data from the Danish Anaesthesia Database (DAD) and the Danish Colorectal Cancer Database will be linked. Quality of life will be assessed using StomaQol and SF-36. Colostomy Impact score will also be obtained. Patients will self-report a parastomal bulge and information such as education, alcohol consumption, physical activity and civil status.

Conditions

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Quality of Life Parastomal Hernia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No intervention, cross-sectional study

Questionnaire, cross-sectional study

Questionnaire

Intervention Type OTHER

No intervention only observational

Interventions

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Questionnaire

No intervention only observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
* temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy