A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,026
- 试验地点
- 1
- 主要终点
- intersphincteric resection (ISR)
研究概览
简要总结
This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.
详细描述
Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.
This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male patients diagnosed with rectal cancer by pathological biopsy;
- •abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
- •Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;
- •Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;
- •The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.
排除标准
- •multiple primary cancers;
- •history of open surgery;
- •no preoperative MR evaluation and inadequate evaluation of tumor stage;
- •Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
- •Pregnant or patients with concomitant inflammatory bowel disease;
- •Patients with preoperative complete bowel obstruction or requiring emergency surgery;
- •Preoperative evaluation indicates that patient may require combined organ resection;
- •Recently receiving treatment for other malignant tumors;
- •Bordeaux type IV low rectal cancer;
- •The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.
- •Exit Criteria
- •Refuse surgical treatment after randomization;
- •Open surgery was performed for treatment after randomization;
- •Patients request to withdraw from the study at any time during the entire study process after randomization
结局指标
主要结局
intersphincteric resection (ISR)
时间窗: during the operation
The primary outcome is the incidence of ISR. ISR is defined according to the definition by a Japanese study group. When the distal resection margin is from dentate line to the intersphincteric groove, ISR will be recorded.The distal resection line of the internal anal sphincter was at the intersphincteric groove in total ISR, between the dentate line and the intersphincteric groove in subtotal ISR and at the dentate line in partial ISR
次要结局
- 30-day postoperative morbidity(within 30 days after operation)
- distance to distal resection margin (DRM)(within 30 days after operation)
- 3-year urinary function(3 years after operation)
- conversion to open(during the operation)
- 3-year overall survival (OS)(3 years after operation)
- The proportion of patients receiving abdominoperineal resection(during the operation)
- 3-year sexual function(3 years after operation)
- 30-day postoperative mortality(within 30 days after operation)
- 3-year disease-free survival (DFS)(3 years after operation)
- 3-year local recurrence rate (LR)(3 years after operation)
- distance to circumferential resection margin (CRM)(within 30 days after operation)
- 3-year defecation function(3 years after operation)
- coloanal anastomosis (CAA)(during the operation)
- conversion to transanal TME (TaTME)(during the operation)
- 3-year quality of life(3 years after operation)
研究者
Quan Wang
Professor
The First Hospital of Jilin University