Quality of LifeNCT03702478
Quality of Life in Patients With and Without a Parastomal Bulge
An observational study of Quality of Life and Parastomal Hernia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Quality of Life, Parastomal Hernia
- What is being tested?
- Questionnaire
- How many people
- 1,453 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Aug 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients registered in the Danish Stoma Database Capital Region, having undergone stoma surgery between 2011 till end of 2016.
Who may be able to join
- permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
- temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
Who cannot join
- age younger than 18 years
- stoma closure at follow-up
- death
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Quality of Life, Parastomal Hernia
- Being tested
- Questionnaire
- Keywords
- Quality of life, hernia, parastomal bulging, stoma, cross-sectional
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
No intervention only observational
| Study group | Role | What they receive |
|---|---|---|
| No intervention, cross-sectional study | Questionnaire, cross-sectional study Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 years after stoma formation
Secondary outcomes (4)
Exploration of the frequency of self-reported parastomal bulging
Investigate the frequency of parastomal bulging
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 7 years after stoma formation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start13 Aug 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Thordis Thomsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702478
- Sponsor's protocol ID
- 16021425
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03702478
- Acronym / sponsor ID
- 16021425
- Conditions
- Quality of Life, Parastomal Hernia
- Keywords
- Quality of life, hernia, parastomal bulging, stoma, cross-sectional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,453 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, Herlev and Gentofte Hospital
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention, cross-sectional study | – | Other: QuestionnaireQuestionnaire, cross-sectional study |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered in the Danish Stoma Database Capital Region, having undergone stoma surgery between 2011 till end of 2016.
Key inclusion criteria (2 listed)
- permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
- temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy
Key exclusion criteria (3 listed)
- age younger than 18 years
- stoma closure at follow-up
- death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireNo intervention only observational | Other | No intervention, cross-sectional study |
Primary outcome
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
4 secondary outcomes
Exploration of the frequency of self-reported parastomal bulging
Time frame: Up to 7 years after stoma formation
Relationship between symptoms and HRQOL measured with StomaQol
Time frame: Up to 7 years after stoma formation
Relationship between PB duration and HRQOL measured with StomaQol and SF-36
Time frame: Up to 7 years after stoma formation
Relationship between PB size and HRQOL measured with SF-36 and StomaQol
Time frame: Up to 7 years after stoma formation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Parastomal Hernia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.