Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- LARS score change comparing before surgery and 1 year after the surgery.
研究概览
简要总结
- Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
- Primary outcome measure: LARS score before surgery and 1 year after the surgery.
- Primary comparison: Between average LARS score before and after curative surgery and also comparing these with publish LARS score on normal population.
详细描述
All patients undergoing treatment for rectal rectal will be included in the study. Before any treatment all the included patients will be asked to fill the LARS score (5 question questionnaire with differently weighted answers for assessing the low anterior resection score). One year after the low anterior resection (without the stoma) or following the stoma take down patients will be reassessed. The LARS score will be filled one again. Patient characteristics, age, cancer stage, level of anastomosis will be assessed aswel.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients undergoing rectal cancer surgery on curative intent.
- •Elective surgery patients.
- •Laparoscopic, laparoscopic-converted, robotic, TaTME (transanal total mesorectal excision) and open cases will be included.
- •Patients aged 18 years and over should be included.
排除标准
- •Patients undergoing a procedure purely for diagnosis or staging should be excluded.
- •Patients with palliative treatment.
- •Patients with recurrence should be excluded.
- •Patients with dementia
- •Patients who do not complete their treatment within 12 months of primary surgery e.g. including reversal of stoma, chemotherapy etc
结局指标
主要结局
LARS score change comparing before surgery and 1 year after the surgery.
时间窗: 12 months
Low anterior resection score is a simple questionnaire consisting of five simple questions for bowel function assessment after anterior resection. The maximum number is between 0 and 42. No LARS (good bowel function) is from 0 to 20; minor LARS - 21-29 and major LARS (poor bowel function) more than 29. Between average LARS score before and after curative surgery and also comparing these with published LARS score on normal population.
次要结局
未报告次要终点
研究者
Audrius Dulskas
Assoc. professor
National Cancer Institute, Lithuania