Chinese Transanal Total Mesorectal Excision Registry Collaborative: A Nationwide Registry Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 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
Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •malignant or benign neoplasms of the rectum
- •the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- •tolerable to surgery
- •be able to understand and willing to participate in this registry with signature
排除标准
- •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
- •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.
The grade score of the specimens integrity
时间窗: 10 days after surgery
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
次要结局
- the severity of postoperative complication assessed by Clavien Dindo grade(30 days after surgery)
- overall survival rate(3-year after surgery)
- disease free survival rate(3-year after surgery)
- local recurrence rate(3 years after surgery)
- the incidence of postoperative complications(30 days after surgery)
- the grade of anastomotic leakage(30 days after surgery)
研究者
Zhongtao Zhang
assistant dean, professor
Beijing Friendship Hospital