StomaFUNQ. Function and Quality of Life After Emergency vs Planned Creation of a Stoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- function of stoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stoma permanently or for shorter period
排除标准
- •not understanding Swedish
研究组 & 干预措施
emergency stoma
an emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer
干预措施: emergency procedure (Procedure)
Planned stoma
a planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer
干预措施: emergency procedure (Procedure)
结局指标
主要结局
function of stoma
时间窗: <3 years of stoma creation
rate of patients experiencing leakage from stoma appliance
Function of stoma
时间窗: < 3 years of creation
rate of patients who are satisfied with stoma function
次要结局
- Patient reported quality of life(3 years after of stoma creation)
研究者
Eva Haglind, MD, PhD, professor
Professor emerita, Consultant
Sahlgrenska University Hospital