Function and Quality of Life After Emergency vs Planned Creation of a Stoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: emergency procedure.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
StomaFUNQ. Function and Quality of Life After Emergency vs Planned Creation of a Stoma
Overview
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
- Procedure emergency procedure
The difference between groups is the timing or type ie emergency as opposed to planned
Primary outcome measures
- Function of stoma [Time frame: < 3 years of creation]
- function of stoma [Time frame: <3 years of stoma creation]
Secondary outcome measures (1)
- Patient reported quality of life [Time frame: 3 years after of stoma creation]
Eligibility criteria
Inclusion criteria
- stoma permanently or for shorter period
Exclusion criteria
- not understanding Swedish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Sweden · 1 center
- Gothenburg University, Sahlgrenska Academy, Institute of Cinical Sciences, Department of S — Gothenburg
Identifiers
NCT: NCT05102981 · 2021-04078