Colorectal CancerStomaFUNQNCT05102981
Function and Quality of Life After Emergency vs Planned Creation of a Stoma
An observational study of Colorectal Cancer, run by Eva Haglind, MD, PhD, professor at 1 site in Sweden.
Trial summary
The aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- emergency procedure
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2024to 30 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all registered individuals who had a primary surgical procedure including a stoma as treatemtn for colon or rectal cancer in Sweden in 2019 and 2020.
Who may be able to join
- stoma permanently or for shorter period
Who cannot join
- not understanding Swedish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Gothenburg University, Sahlgrenska Academy, Institute of Cinical Sciences, Department of Surgery
Gothenburg
About this study
Official title: StomaFUNQ. Function and Quality of Life After Emergency vs Planned Creation of a Stoma
The aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. To do this data will be retrieved from the Swedish Patient Register to identify all patients with a diagnosis of colorectal cancer and a stoma construction procedure during two previous calender years. To collect data on stoma function and quality of life a specific questionnaire will be sent to the cohort approximately within 2 years of the procedure.
Read the detailed description
The cohort will be identified through the National in-Patient Register, held by the Swedish Board of Health and Welfare, by using a combination of ICD10 and NOMESCO codes. Two calender years will be the collecytion period to reach group size allowing for statistical analysis. Data from the register will be used to describe the groups (demography) and data from the prescribed drug register to calculate costs for stoma appliances after discharge.
Using the patient ID, all patients still alive at the time, will be contacted first by a letter followed within 2-4 days by a phomecall from the study secretariate, to ask for consent and thereafter to send out the questionnaire.
The questionnaire includes validated questions used before as well as validated instruments, to analyze stoma function in detail as well as quality fo life, as well as questions where answers will be used for adjustment in analyses.
- Conditions
- Colorectal Cancer
- Being tested
- emergency procedure
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency procedureProcedure or surgery
The difference between groups is the timing or type ie emergency as opposed to planned
| Study group | Role | What they receive |
|---|---|---|
| emergency stoma | an emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer Receives: Procedure: emergency procedure | |
| Planned stoma | a planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer Receives: Procedure: emergency procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function of stoma
rate of patients who are satisfied with stoma function
Measured: < 3 years of creation
function of stoma
rate of patients experiencing leakage from stoma appliance
Measured: <3 years of stoma creation
Secondary outcomes (1)
Patient reported quality of life
Patient reported quality of life by question: "How was your quality of life during the last month?" answered through a 7 step Likert scale anchored by "worst possible" and "best possible"
Measured: 3 years after of stoma creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Nov 2024
- Primary completion30 Jun 2025
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Eva Haglind, MD, PhD, professor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102981
- Sponsor's protocol ID
- 2021-04078
- Acronym
- StomaFUNQ
- Status last verified
- May 2025
- First submitted
- 18 Oct 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StomaFUNQ. Function and Quality of Life After Emergency vs Planned Creation of a Stoma
- ClinicalTrials.gov ID
- NCT05102981
- Acronym / sponsor ID
- StomaFUNQ / 2021-04078
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Eva Haglind, MD, PhD, professorUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Nov 2021 (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.
The aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. To do this data will be retrieved from the Swedish Patient Register to identify all patients with a diagnosis of colorectal cancer and a stoma construction procedure during two previous calender years. To collect data on stoma function and quality of life a specific questionnaire will be sent to the cohort approximately within 2 years of the procedure.
Detailed description
The cohort will be identified through the National in-Patient Register, held by the Swedish Board of Health and Welfare, by using a combination of ICD10 and NOMESCO codes. Two calender years will be the collecytion period to reach group size allowing for statistical analysis. Data from the register will be used to describe the groups (demography) and data from the prescribed drug register to calculate costs for stoma appliances after discharge.
Using the patient ID, all patients still alive at the time, will be contacted first by a letter followed within 2-4 days by a phomecall from the study secretariate, to ask for consent and thereafter to send out the questionnaire.
The questionnaire includes validated questions used before as well as validated instruments, to analyze stoma function in detail as well as quality fo life, as well as questions where answers will be used for adjustment in analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emergency stoma | – | Procedure: emergency procedurean emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer |
| Planned stoma | – | Procedure: emergency procedurea planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all registered individuals who had a primary surgical procedure including a stoma as treatemtn for colon or rectal cancer in Sweden in 2019 and 2020.
Key inclusion criteria (1 listed)
- stoma permanently or for shorter period
Key exclusion criteria (1 listed)
- not understanding Swedish
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 |
|---|---|---|
| emergency procedureThe difference between groups is the timing or type ie emergency as opposed to planned | Procedure or surgery | Planned stoma, emergency stoma |
Primary outcome
Function of stoma
Time frame: < 3 years of creation
rate of patients who are satisfied with stoma function
function of stoma
Time frame: <3 years of stoma creation
rate of patients experiencing leakage from stoma appliance
1 secondary outcome
Patient reported quality of life
Time frame: 3 years after of stoma creation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- 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.
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 Colorectal Cancer, run by Eva Haglind, MD, PhD, professor at 1 site in Sweden.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Function of stoma (time frame: < 3 years of creation). The study lists 2 primary outcomes in all. 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 27 Apr 2026.