Clinical trial NCT03702478: Quality of Life in Patients With and Without a Parastomal Bulge
Official title: Quality of Life in Patients With and Without a Parastomal Bulge - a Cross-sectional Study of Patients in the Danish Stoma Database Capital Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Parastomal Hernia
Keywords: Quality of life
hernia
parastomal bulging
stoma
cross-sectional
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
name: Herlev and Gentofte Hospital
First posted: 2018-10-11
Enrollment: 1453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in the Danish Stoma Database Capital Region, having undergone stoma surgery between 2011 till end of 2016.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life (SF-36 ) and Stoma related Qol (StomaQol) in relation to stoma type or underlying condition
timeFrame: Up to 7 years after stoma formation
Secondary outcomes:
measure: Exploration of the frequency of self-reported parastomal bulging
timeFrame: Up to 7 years after stoma formation
measure: Relationship between symptoms and HRQOL measured with StomaQol
timeFrame: Up to 7 years after stoma formation
measure: Relationship between PB duration and HRQOL measured with StomaQol and SF-36
timeFrame: Up to 7 years after stoma formation
measure: Relationship between PB size and HRQOL measured with SF-36 and StomaQol
timeFrame: Up to 7 years after stoma formation
Other outcomes:
measure: Alcohol consumption measured by Time-line-follow-back
timeFrame: Up to 7 years after stoma formation
measure: Physical activity measured with high or low intensity questions. A non-validated physical activity scale
timeFrame: Up to 7 years after stoma formation.
measure: Smoking measured by selfreported smoking status. A non-validated scale
timeFrame: Up to 7 years after stoma formation
Locations:
city: Copenhagen
country: Denmark
facility: Marianne Krogsgaard
Study officials:
References: