Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Positive rate of circumferential resection margin (CRM) of the specimens
研究概览
简要总结
At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenocarcinoma of the rectum by biopsy
- •the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- •tumor diameter less than 4cm
- •baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
- •tolerable to surgery
- •be able to understand and willing to participate in this trial with signature
排除标准
- •history of malignant colorectal neoplasia
- •recent diagnosis with other malignancies
- •patients requiring emergency surgery such as obstruction，perforation and bleeding
- •tumor involving adjacent organs, anal sphincter, or levator ani muscle
- •muti-focal colorectal cancer
- •preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
- •history of inflammatory bowel disease or familial adenomatous polyposis
- •participating in other clinical trails
- •can not tolerate the surgery
- •history of serious mental illness
- •pregnancy or lactating women
- •preoperative uncontrolled infection
- •the researchers believe the patients should not enrolled in
结局指标
主要结局
Positive rate of circumferential resection margin (CRM) of the specimens
时间窗: 10 days after surgery
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.
次要结局
- the operative time(30 days after surgery)
- the rate of postoperative complications(30 days after surgery)
- The grade score of the specimens integrity(10 days after surgery)
- the score of postoperative life(6 months after surgery)
- The distance between lower tumor margin and the lower reaction margin(10 days after surgery)
- local recurrence rate(3 years after surgery)
- postoperative hospital stay(3 year after surgery)
- overall survival rate(3-year after surgery)
- disease free survival rate(3-year after surgery)
研究者
Zhongtao Zhang
assistant dean, professor
Beijing Friendship Hospital