Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in quality of life specific for the gastrointestinal tract
研究概览
简要总结
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.
详细描述
In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.
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
- •age older than 18,
- •low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
- •German speaking patient who is capable to fill in the questionnaire,
- •signed informed consent
排除标准
- •age younger than 18,
- •preoperative stoma,
- •not German speaking
- •inability to fill in the questionnaire,
- •no standardized chemo- and radiotherapy
结局指标
主要结局
Change in quality of life specific for the gastrointestinal tract
时间窗: at Baseline and up to 12 months after surgery
GIQLI Score
次要结局
- Change in quality of life(at Baseline and up to 12 months after surgery)
- Change in faecal Incontinence(at Baseline and up to 12 months after surgery)
