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Function and Quality of Life After Emergency vs Planned Creation of a Stoma

StomaFUNQ. Function and Quality of Life After Emergency vs Planned Creation of a Stoma

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05102981
Acronym
StomaFUNQ
Enrollment
700
Registered
2021-11-02
Start date
2024-11-01
Completion date
2027-12-30
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief 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. 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.

Interventions

PROCEDUREemergency procedure

The difference between groups is the timing or type ie emergency as opposed to planned

Sponsors

Eva Haglind, MD, PhD, professor
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* stoma permanently or for shorter period

Exclusion criteria

* not understanding Swedish

Design outcomes

Primary

MeasureTime frameDescription
Function of stoma< 3 years of creationrate of patients who are satisfied with stoma function
function of stoma<3 years of stoma creationrate of patients experiencing leakage from stoma appliance

Secondary

MeasureTime frameDescription
Patient reported quality of life3 years after of stoma creationPatient 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"

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026