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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: emergency procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stoma permanently or for shorter period Exclusion Criteria: not understanding Swedish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| emergency stoma<br>an emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer | Procedure: emergency procedure<br>* The difference between groups is the timing or type ie emergency as opposed to planned<br>|
| Planned stoma<br>a planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer | Procedure: emergency procedure<br>* The difference between groups is the timing or type ie emergency as opposed to planned<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function of stoma | rate of patients who are satisfied with stoma function | < 3 years of creation | 
| function of stoma | rate of patients experiencing leakage from stoma appliance | <3 years of stoma creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | How was your quality of life last month? answered through Likert scale anchored by worst possible and bbest possible respectively | < 3 years of stoma creation |