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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| emergency stoma | an emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer |
| |
| Planned stoma | a planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emergency procedure | Procedure | The difference between groups is the timing or type ie emergency as opposed to planned |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 3 years after of stoma creation |
| Measure | Description | Time Frame |
|---|---|---|
| cost of stoma care | health economic analysis of costs such as of stoma appliances, visits to stoma nurses, re-operations to improve stoma and/or repair a parastomal hernia | < 3 years of stoma construction |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gothenburg University, Sahlgrenska Academy, Institute of Cinical Sciences, Department of Surgery | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |