Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- 3-year local recurrence
研究概览
简要总结
This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).
详细描述
In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
- •Patients undergoing elective, radial surgery with no distant metastasis.
- •Patients with Body Mass Index (BMI) between 18-30kg/m
- •Patients who agree to undergo standard adjuvant treatment after surgery.
- •Patients who have fully understood the aim of the trial and have signed the written informed consent.
排除标准
- •Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
- •Patients undergoing emergent surgery.
- •Pregnant patients.
- •Patients with tumors other than rectal tumor.
- •Patients with severe comorbid diseases which preclude surgery.
- •Patients in bad conditions and do not ameliorate before surgery.
- •Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.
- •Patients who refuse to accept standard adjuvant surgery.
结局指标
主要结局
3-year local recurrence
时间窗: 3 years post operation
次要结局
- 3-year overall survival(3 years post operation)
- 3-year disease-free survival(3 years post operation)
研究者
Bo Feng
Assistent professor of surgery
Ruijin Hospital
