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临床试验/NCT06454201
NCT06454201已完成不适用

the First Affiliated Hospital of Nanchang University

Nanchang University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
The rate of all complications (Clavien-Dindo grade ≥ III )

研究概览

简要总结

The purpose of this study is to evaluate the short-term outcomes of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery in the treatment of median rectal cancer. The main question it aims to answer is: is it safe and feasible to perform roboric natural orifice specimen extraction surgery (NOSES-II) for median rectal cancer? What are the advantages of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery for median rectal cancer.

详细描述

A major concern to the safety of the public's health is the prevalence of colorectal cancer, which is the third most prevalent cancer and has a very high fatality rate. There are multiple treatments for rectal cancer, and surgery remains one of the most important ways. Laparoscopic surgery as a minimally invasive technique for the treatment of colorectal has been confirmed by many studies to ensure its safety and reliability. Laparoscopic surgery has also been widely used in clinical. So far, NOSES, as an emerging minimally invasive technology, has caused heated discussions in the minimally invasive surgical community, especially in rectal surgery, the emergence of NOSES, which solves the problems caused by incisions in traditional surgery, improves the mental health of patients, and has good short-term efficacy. In recent years, the popularity of robotic colorectal cancer surgery has been rising, and the concepts of radical treatment, precision, and minimally invasive have been continuously refined, and NOSES surgery, as an emerging minimally invasive technology, has further reduced the impact of surgical trauma on the body, eliminated abdominal scar incision, and avoided complications related to abdominal wall incision, and has been widely used and carried out. In addition to the benefits of patients, the high-definition lens of the robotic surgery system and the flexible robotic arm greatly remove the trembling of the operator's hand, improve the flexibility and accuracy of the operator's operation, and are more conducive to challenging operations in narrow spaces. Compared with laparoscopy, the robotic surgical system has great advantages in some aspects, such as postoperative patient urination function, sexual function, surgical complications. Robotic surgical systems, combined with NOSES, may bring greater benefits to patients.

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

  • The age is more than 18 years old and less than or equal to 85 years old
  • Eastern Cooperative Oncology Group score ≤2
  • Preoperative pathological diagnosis of rectal adenocarcinoma
  • cT1-3NxM0 median rectal cancer defined by preoperative contrast-enhanced MRI
  • The maximum diameter of tumor ≤5cm on preoperative enhanced MRI
  • The body can tolerate the operation and sign the informed consent

排除标准

  • multiple primary colorectal cancer
  • recurrent rectal cancer
  • preoperative neoadjuvant chemoradiotherapy
  • complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery
  • previous anal surgery history
  • BMI≥30kg/m2
  • severe mental illness

研究组 & 干预措施

robotic natural orifice specimen extraction surgery for middle rectal cancer

Active Comparator

After the body is free, the tumor segment of the bowel is pulled out through the anus. Excise the tumor segment of the colon outside the anus.

干预措施: robotic natural orifice specimen extraction surgery (Procedure)

robotic transabdominal specimen extraction surgery for middle rectal cancer

Sham Comparator

After internal mobilization, the tumor segment of the bowel was removed through an abdominal incision. Excise the tumor segment of the bowel outside the incision.

干预措施: robotic transabdominal specimen extraction surgery (Procedure)

结局指标

主要结局

The rate of all complications (Clavien-Dindo grade ≥ III )

时间窗: 1 months after surgery

incidence rate

The rate of anastomotic complications

时间窗: 1 months after surgery

Anastomotic leakage and anastomotic bleeding

The rate of all complications

时间窗: 1 months after surgery

incidence rate

次要结局

  • postoperative hospital stay(1 day after operation)
  • estimation of blood loss(Intraoperative)
  • operative time(Intraoperative)
  • visual analogue pain score(1 weeks after surgery)

研究者

发起方
Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Taiyuan Li

professor

Nanchang University

研究点 (1)

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