Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,502
- 主要终点
- disease-free survival ratev
研究概览
简要总结
The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.
详细描述
Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age between 18 and 80 years old
- •Confirmed rectal adenocarcinoma cancer pathologically
- •Tumor location ≦ 12 cm from the anal margin
- •Willing and able to provide written informed consent for participation in this study
排除标准
- •Distant metastasis before surgery
- •More than one colorectal tumor at diagnosis
- •Familial adenomatous polyposis
- •Recurrent rectal cancer
- •Undergo transanal minimally invasive surgery
- •Undergo palliative treatment
- •Undergo emergency surgery
结局指标
主要结局
disease-free survival ratev
时间窗: 5 years after the surgery
Overall survival rate
时间窗: 5 years after the surgery
次要结局
- Cancer special survival rate(5 years after the surgery)
- CRM status(30 days after the surgery)
- DRM status(30 days after the surgery)
- Quality of the mesorectum specimen(30 days after the surgery)
- Local recurrence rate(3 years after the surgery)
研究者
Yanhong Deng
Professor
Sun Yat-sen University