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临床试验/NCT02812628
NCT02812628Unknown不适用

Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2012年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Feng

Assistent professor of surgery

Ruijin Hospital

研究点 (1)

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