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临床试验/NCT06753968
NCT06753968已完成不适用

The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer

National Cancer Center, China1 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
349
试验地点
1
主要终点
The rate of postoperative complications

研究概览

简要总结

The purpose of this study is to investigate the short-term and long-term outcomes between natural orifice specimen extraction surgery (NOSES) and totally laparoscopic right hemicolectomy (TLRH). The hypothesis is that NOSES could achieve good short-term and oncological outcomes for right colon cancer patients.

详细描述

This study is a retrospective clinical study. We reviewed collected data from all patients who underwent laparoscopic curative resection for stage I-III right-sided colon cancer between January 2018 and January 2023. A total of consecutive 115 patients who underwent laparoscopic resection with transvaginal or transrectal specimen extraction were identified as the NOSES group. To establish a comparative cohort, 234 patients who underwent totally laparoscopic right hemicolectomy (TLRH) during the same period were selected. The purpose of this study is to investigate the short-term and long-term outcomes between NOSES and TLRH. The hypothesis is that NOSES could promote postoperative recovery, reduce incision-related complications with comaprable long-term oncological outcomes when compared with TLRH.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Biopsy proven colon carcinoma;
  • Imaging diagnosis of T1-3 colon cancer;
  • The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
  • Written informed consent;

排除标准

  • Complete intestinal obstruction;
  • Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
  • Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
  • Pregnancy or breastfeeding;
  • Alcohol abuse or drug addiction;
  • Concurrent uncontrolled medical condition;

结局指标

主要结局

The rate of postoperative complications

时间窗: up to 30 days

The rate of postoperative complications = patients with any postoperative complications/all cases.

次要结局

  • Operating time(up to 1 days)
  • The time of first flatus(up to 5 days)
  • Postoperative hospitalization(up to 30 days)

研究者

发起方
National Cancer Center, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haitao Zhou

Professor Haitao Zhou

National Cancer Center, China

研究点 (1)

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