Does Transanal Total Mesorectal Excision (taTME) Result in Better Quality of Life and Functional Outcomes Than Traditional Total Mesorectal Excision? A Retrospective Propensity Score-adjusted Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Quality of life (QoL)
研究概览
简要总结
The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)
详细描述
Quality of life and functional outcomes of patients undergoing taTME or abTME for stage I-III rectal cancer will be analysed. A retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. The primary endpoint QoL will be assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30). Secondary endpoints are the functional outcomes according to the EORTC QLQ-C30 questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer
排除标准
- •diagnoses other than rectal cancer
- •recurrent rectal cancer
- •partial mesorectal excision
- •discontinuity resection (no anastomosis)
- •incomplete TNM staging information
- •metastatic cancer
- •30-day mortality
- •lack of quality of life data
- •patient decline
- •age under 18 years
结局指标
主要结局
Quality of life (QoL)
时间窗: 5 years after initial operation
Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30): * Overall QoL * QLQ-total
次要结局
- Functional outcomes(5 years after initial operation)
研究者
Yanic Ammann
Dr. med.
Cantonal Hospital of St. Gallen