Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Low Anterior Resection Syndrome score ( LARS Score)
研究概览
简要总结
The primary objectives are to evaluate the prevalence of LARS and Quality of Life in rectal cancer patients 3 years after anterior resection, to investigate if anastomotic technique is a risk factor for major LARS and to study the prevalence of colostomy 3 years after anterior resection and evaluate stoma function according to the stoma scale in EORTC QLQ-CR29.
详细描述
All patients who have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 have been identified in the Swedish Colorectal Cancer Registry (SCRCR). Three years after surgery the patients were sent a questionnaire including the LARS (Low Anterior Resection Syndrome)-score, the quality of life questionnaire EORTC QLQ 30 and CR29 in addition to a questionnaire regarding prevalence of remaining stoma.The patient cohort will be divided into two groups operated with total (TME) or partial (PME) mesorectal excision for further analyses. Patients with a stoma will be analysed separately.
Prevalence of major LARS and Quality of Life, QoL, 3 years after anterior resection will be assessed by the EORTC QLQ-C30 and by calculation of LARS Score with categories "no" (0-20 points), "minor" (21-29) and "major" (30-42). The LARS score will be dichotomized into the categories no/minor and major LARS.
Stoma function will be evaluated by the stoma scale in EORTC QLQ-CR29.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Clinical diagnosis of rectal cancer in Sweden
- •Operated on with anterior resection between Q1 2015 and Q4 2017 in Sweden, with or without defunctioning stoma
排除标准
- •Age <18 years
- •Dementia,
- •Unable to understand Swedish language
结局指标
主要结局
Low Anterior Resection Syndrome score ( LARS Score)
时间窗: 3 years
Prevalence of low anterior resection syndrome (LARS) 3 years after low anterior resection for rectal cancer, assessed by the validated instrument LARS score consisting of 5 questions with a total score of between 4 and 42. .0-20 corresponds to no LARS, 21-29 to minor LARS and 30-42 to major LARS.
QoL
时间窗: 3 years
Quality of life measured by the validated EORTC (European Organisation for Research and Treatment of Cancer) questionnaires QLQ 30 (Quality of life questionnaire 30) consisting of 30 questions and CR 29 (colirecti 29), a specific questionnaire assessing quality of life in colorectal cancer patients, consisting of 29 questions. Both QLQ 30 and CR 29 include symptom scales and functional scales from 0-100 with lower scores on symptom scales indicating better quality of life and higher scores on functional scales indicating better quality of life.
次要结局
- Correlation LARS score QoL(3 years)