Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Stool frequency
研究概览
简要总结
CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.
详细描述
This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There is no masking in the CSAR Trial
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
- •Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum
- •Local curative approach
- •Normal continence preoperatively
- •Non-IBD-associated carcinoma
- •Possible sphincter salvage
- •Signed informed consent
排除标准
- •Non-curative approaches
- •Emergency surgery in cases of tumor perforation, abscess, sepsis
- •Proximal rectal carcinoma (> 12 cm from anocutaneous line)
- •Lack of informed consent
- •Age <18 years
- •Inclusion in other trials with interference of endpoints
- •Life expectancy less than 24 months (as estimated by the treating physicians)
- •Pregnancy
- •Immunosuppression
结局指标
主要结局
Stool frequency
时间窗: time = 6 months postoperative
Between group differences in stool frequency at t = 6 months postoperative
次要结局
- Postoperative complications(through study completion (an average of 12 months postoperative))
- Quality of Life(baseline, postoperative (2-3 months, 6 months, 12 months))
- Antimotility drug usage(baseline, postoperative (2-3 months, 6 months, 12 months))
研究者
Markus Rentsch
Principal Investigator
Ludwig-Maximilians - University of Munich