Quality of Life in Patients With and Without a Parastomal Bulge

NCT03702478 | Completed DMC

• 1 other identifier: 16021425
• Study Type: observational
• Target: 1,453
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Parastomal Hernia

Keywords

Quality of life; hernia; parastomal bulging; stoma; cross-sectional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Exploration of the frequency of self-reported parastomal bulging

  Up to 7 years after stoma formation

• Relationship between symptoms and HRQOL measured with StomaQol

  Up to 7 years after stoma formation

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

  Up to 7 years after stoma formation

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

  Up to 7 years after stoma formation

Other Outcomes (3)

• Alcohol consumption measured by Time-line-follow-back

  Up to 7 years after stoma formation

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

  Up to 7 years after stoma formation.

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

  Up to 7 years after stoma formation

Study Arms (1)

No intervention, cross-sectional study

Questionnaire, cross-sectional study

Other: Questionnaire

Interventions

Questionnaire OTHER

No intervention only observational

No intervention, cross-sectional study

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
• temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy

You may not qualify if:

• age younger than 18 years
• stoma closure at follow-up
• death

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Marianne Krogsgaard

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hernia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: October 11, 2018
• Study Start: August 13, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)