Clinical Trial to Evaluate Quality of Life, Period of Hospitalization and Complication Rates in Patients With Stoma Receiving Specific Preoperative Education vs. Standard Preoperative Education
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- Quality of Life
研究概览
简要总结
Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.
详细描述
The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Planned stoma
- •colorectal cancer, from resection of left hemi-colon aboral A. colica media
- •Patients speaking german and living in Germany
- •Informed Consent
- •standard education program
排除标准
- •Patients treated with stoma by emergency
- •patients with dementia
- •status post stoma
- •Patients in contact with a stoma-therapist
- •recurrence of colorectal cancer
研究组 & 干预措施
Krankenhaus Nordwest Concept
specific preoperative education program realised by a specialized stoma-therapist containing individualized information on material maintenance, hygiene, nutrition, complications, activities of daily life and occupation
干预措施: Education program (Other)
Standard concept
standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives
干预措施: Education program (Other)
结局指标
主要结局
Quality of Life
时间窗: 4 weeks after surgery
Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points
Quality of life
时间窗: 9-15 days after surgery
Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points
次要结局
- Period of hospitalization(9-15 days after surgery, 4 weeks after surgery)
- Complication rates(9-15 days after surgery, 4 weeks after surgery)