Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- measurement of circumferential resection margin
研究概览
简要总结
This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.
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
- Double (Participant, Outcomes Assessor)
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
- •Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
- •Stage T3 or T4 at MRI
- •N0-2 at MRI
- •M0 at CT scan
- •Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents
排除标准
- •Squamous cell carcinoma
- •Adenocarcinoma Stage T1-2, any N
- •T4 with one of the following:
- •with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy
结局指标
主要结局
measurement of circumferential resection margin
时间窗: 0-10 minutes post surgery
Measurement in millimeters (mm) of the circumferential resection margin.
次要结局
- operative time(4-6 hours)
- hospital stay(from beginning of surgery through discharge, usually 4-5 days)
- estimated blood loss(4-6 hours)
研究者
Roberto Bergamaschi
Professor and Chief, Colon and Rectal Surgery
Stony Brook University