Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Circumferential resection margin (CRM)
研究概览
简要总结
This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.
详细描述
Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.
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
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
- •18 years < age < 80 years
- •Body mass index (BMI) <30 kg/m2
- •Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection)
- •Pathological rectal carcinoma
- •Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
- •Tumor size of 5 cm or less
- •ECOG score is 0-1
- •ASA score is Ⅰ-Ⅲ
- •Informed consent
排除标准
- •Requiring a Mile's procedure
- •Fecal incontinence
- •History of inflammatory bowel disease
- •Pregnant woman or lactating woman
- •Severe mental disease
- •Intolerance of surgery for severe comorbidities
- •Previous abdominal surgery
- •Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer
- •Requirement of simultaneous surgery for other disease
结局指标
主要结局
Circumferential resection margin (CRM)
时间窗: 14 days after surgery
Positive rate of circumferential resection margin (pathological assessment)
次要结局
- Completeness of mesorectum(14 days after surgery)
- Lymph node detection(14 days after surgery)
- Distal safety margin(14 days after surgery)
- Operative time(Intraoperative)
- Intraoperative blood loss(Intraoperative)
- Length of stay(1-30 days after surgery)
- Postoperative recovery course(1-14 days after surgery)
- Early morbidity rate(30 days)
- Pain score(1-3 days after surgery)
- 3-year disease free survival rate(36 months after surgery)
- 5-year overall survival rate(60 months after surgery)