Retrospective Study of APR Results Regarding Patients' Self Reported Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
研究概览
简要总结
The purpose of the study is to compare self-reported health related quality of life after two different operating techniques for low rectal cancer operated by rectal amputation, using a specific and detailed questionnaire. The population has been operated over a 6 year period in one university hospital.
详细描述
Low rectal cancer treated by abdominoperineal resection (APR, rectal amputation)has worse prognosis than other rectal cancers, both regarding local recurrence and cancer specific survival. With a view to improve local recurrence rates a more extensive perineal operation (excision of the levator muscle) has been suggested. In our university hospital thie technique was introduced for all surgeons January 2007. A population of all patients operated from 1 January 2007 to 31 December 2009 was compared to all patients operated from 1 January 2004 to 31 December 2006 using the traditional, less extensive method, in all a six year period and 158 patients.
A specific questionnaire was developed after in depth interviews, and was face-validated by patients who had undergone an APR. This questionnaire will be sent out to all patients in our population who are still alive.
The patients will be contacted first by a letter of invitation, later called by telephone to be given more information and asked for permission to send the questionnaire.
The send out of invitation letters will start March 2011.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal cancer operated by abdominoperineal resection 2004-2009
排除标准
- •no informed consent
结局指标
主要结局
Health Related Quality of life after rectal cancer surgery - possible differences due to choice of procedure
时间窗: 2-7 years after operation
A detailed questionnaire with 250 questions, where emphasis is on physical satisfaction and emotional status as well as bowel function, sexual function and stoma function 2-7 years after rectal amputation
次要结局
- Impact of rectal cancer surgery and the level of intrusive thoughts(2-7 years after operation)
- Impact of rectal cancer surgery on household finances in a long-term perspective(2-7 years after operation)
研究者
Eva Angenete
M.D., Ph.D.
Sahlgrenska University Hospital, Sweden