Quality of Life in Patients With and Without a Parastomal Bulge
Quality of Life in Patients With and Without a Parastomal Bulge
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.
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.
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