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Completed

NCT Number: NCT03702478

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.

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Key information

Conditions

Quality of Life Hernia Parastomal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marianne Krogsgaard

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

No intervention only observational

Primary outcomes

  1. Health related quality of life (SF-36 ) and Stoma related Qol (StomaQol) in relation to stoma type or underlying condition

    Time frame: Up to 7 years after stoma formation

    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

Secondary outcomes

  1. Exploration of the frequency of self-reported parastomal bulging

    Time frame: Up to 7 years after stoma formation

    Investigate the frequency of parastomal bulging

  2. Relationship between symptoms and HRQOL measured with StomaQol

    Time frame: Up to 7 years after stoma formation

    Investigate the relationship between symptoms in the Stomaqol scale and overall score

  3. Relationship between PB duration and HRQOL measured with StomaQol and SF-36

    Time frame: Up to 7 years after stoma formation

    The association between duration of PB and overall scores on SF-36 and StomaQol

  4. Relationship between PB size and HRQOL measured with SF-36 and StomaQol

    Time frame: Up to 7 years after stoma formation

    The association between duration of PB and overall scores on SF-36 and StomaQol

Other outcomes

  1. Alcohol consumption measured by Time-line-follow-back

    Time frame: Up to 7 years after stoma formation

    Exploration of the distribution of alcohol consumption in stoma patients with and without parastomal bulging.

  2. Physical activity measured with high or low intensity questions. A non-validated physical activity scale

    Time frame: Up to 7 years after stoma formation.

    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.

  3. Smoking measured by selfreported smoking status. A non-validated scale

    Time frame: Up to 7 years after stoma formation

    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'.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Herlev and Gentofte Hospital
  • The Novo Nordic Foundation

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2018
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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