Quality of Life in Patients With and Without a Parastomal Bulge

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Parastomal Hernia
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 1453

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Marianne Krogsgaard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No intervention, cross-sectional study; Questionnaire, cross-sectional study	Other: Questionnaire; No intervention only observational

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol consumption measured by Time-line-follow-back	Exploration of the distribution of alcohol consumption in stoma patients with and without parastomal bulging.	Up to 7 years after stoma formation
Physical activity measured with high or low intensity questions. A non-validated physical activity scale	Exploration of the distribution of high and low intensity physical activity in stoma patients with and without parastomal bulging. High intensity physical activity as for example running, playing football or tennis, measured in minutes (min.) pr week. Scale: 0 min, <30 min., 30-59 min., 60-120 min. and >120 min. Values <30 min. or 0 min. is considered low physical activity of high-intensity. 30-59 min. is considered medium physical activity of high intensity. Values > 60 min ia considered high physical activity level of high intensity. Low intensity physical activity as for example walking, doing the garden or cleaning the house, measured in minutes pr week. Scale: 0 min., <30 min., 30-60 min., 61-90 min., 91-150 min., 151-300 min. and >300 min. Values <60 min is considered low physical activity of low intensity. Values from 61-150 is considered medium physical activity of low intensity. Values from 151 or more is considered high physical activity level of low intensity.	Up to 7 years after stoma formation.
Smoking measured by selfreported smoking status. A non-validated scale	Exploration of the distribution of smoking in stoma patients with and without parastomal bulging. Smoking status is categorised as never smoked, stopped smoking for > 6 months, stopped smoking < 6 months, smoking occationally, smoking every day. The category never smoked will be categorised as 'never smoker'. The categories stopped smoking < or > than 6 months ago will be categorised as 'previous smoker'. The categories smoking occationally and smoking every day will be categorised as 'current smokers'.	Up to 7 years after stoma formation

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: The Novo Nordic Foundation; Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2018
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; hernia; cross-sectional; parastomal bulging; stoma
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 16021425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No