Quality of Life in Patients With and Without a Parastomal Bulge

Study Overview
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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.

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.

Official Title
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Quality of Life in Patients With and Without a Parastomal Bulge - a Cross-sectional Study of Patients in the Danish Stoma Database Capital Region

Conditions
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Quality of Life, Parastomal Hernia

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy Exclusion Criteria: age younger than 18 years stoma closure at follow-up death

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No intervention, cross-sectional study<br>Questionnaire, cross-sectional study | Other: Questionnaire<br>* No intervention only observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (SF-36 ) and Stoma related Qol (StomaQol) in relation to stoma type or underlying condition | Investigate and compare HRQoL in patients with and without a self-reported parastomal bulge in relation to an ileostomy or colostomy. HRQol is measured with SF-36 and StomaQol | Up to 7 years after stoma formation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploration of the frequency of self-reported parastomal bulging | Investigate the frequency of parastomal bulging | Up to 7 years after stoma formation | 
| Relationship between symptoms and HRQOL measured with StomaQol | Investigate the relationship between symptoms in the Stomaqol scale and overall score | Up to 7 years after stoma formation | 
| Relationship between PB duration and HRQOL measured with StomaQol and SF-36 | The association between duration of PB and overall scores on SF-36 and StomaQol | Up to 7 years after stoma formation | 
| Relationship between PB size and HRQOL measured with SF-36 and StomaQol | The association between duration of PB and overall scores on SF-36 and StomaQol | Up to 7 years after stoma formation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, hernia, parastomal bulging, stoma, cross-sectional