跳至主要内容
临床试验/NCT05201885
NCT05201885招募中不适用

Oncological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.

Yanhong Deng1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
192
试验地点
1
主要终点
The positive rate of oncological contamination of peritoneal washings

研究概览

简要总结

The primary purpose of this study is to compare the differences of oncological in rectal cancer patients undergoing laparoscopic or transanal endoscopy radical resection. The secondary purpose is to compare the effect of two different surgical methods on prognosis.

详细描述

Transanal total mesorectal excision (taTME) is a new surgical procedure for total mesorectal excision (TME) by dissociating the mesorectum from the bottom through transanal endoscopic. The characteristics of TaTME are mainly summarized as transanal reverse operation, no auxiliary abdominal incision, complete mesorectal excision and specimen removal through the anus. So taTME is a natural orifice specimen extraction procedure (NOSES). However, similar to NOSES, the specific surgical approach to taTME surgery may raise oncological safety concerns. Due to the premature contact with the tumor, the squeezing of the tumor cannot be avoided during the operation. The tumor may also be squeezed when the specimen is removed through the anus, putting the tumor cells at risk of shedding into the abdominal and pelvic cavity.

Whether TaTME is safe and feasible still needs strong evidence-based medical evidence. However, there have been prospective studies related to oncological in NOSES surgery, but there is a lack of prospective clinical studies on the issue of oncological diffusion during taTME surgery. Therefore, the investigators conducted a randomized controlled study to collect the abdominal and pelvic irrigation fluids in the transanal and laparoscopic TME surgery for oncological examination, to clarify the influence of the two different surgical methods on the intraoperative oncological diffusion. The purpose of this study was to clarify the effect of two different surgical methods on intraoperative tumor cell proliferation, and to compare the long-term oncological outcomes of the two surgical methods, so as to provide more evidence-based medical evidence for the safety of taTME surgery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary rectal carcinoma
  • Single lesion
  • No metastasis

排除标准

  • History of malignant tumors
  • Acute bowel obstruction, bleeding or perforation
  • Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
  • Severe other contradictions of surgery
  • Pregnant women will be excluded

结局指标

主要结局

The positive rate of oncological contamination of peritoneal washings

时间窗: 1 years

Determination of tumor cell positive rate by tumor cell examination of peritoneal washings

次要结局

  • Disease free survival(3 years)

研究者

发起方
Yanhong Deng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanhong Deng

Director

Sun Yat-sen University

研究点 (1)

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