跳至主要内容
临床试验/NCT03570684
NCT03570684Unknown不适用

Utility of Cable Tie in Laparoscopic Anterior Resection of Rectal Cancer to Decline Reloads of Endoscopic Linear Cutter During the Transection of Rectum

West China Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
the number of reloads during the surgery

研究概览

简要总结

During the laparoscopic anterior resection of rectal cancer, transecting the mobilized rectum in the narrow pelvic was difficult and sometimes need 2-3 reloads of the endoscopic linear cutter. also the angles between the 2-3 staple line threaten the next anastomosis. this study was to explore the Cable Tie to facilitate the transection of rectum and decline the usage of the reloads.

详细描述

In the modern laparoscopic colorectal surgery, application of endoscopic stapler was necessary and popular, especially in rectal cancer. In the anterior resection of rectal cancer, usage of stapler increase the anal preservation. However during the laparoscopic anterior resection, transecting the mobilized rectum in the narrow pelvic was difficult, even with the flexible linear cutter. 1 reloads of the stapler was unable to transect the rectum completely, and need 2-3 reloads, especially in some fat patients, which was uneconomic.Also increased reloads increase the staple line, and 2 or 3 staple line threaten the next anastomosis, and increasing anastomotic leak rate. this study was to explore the Cable Tie to facilitate the transection of rectum and decline the usage of the reloads. During the operation, after mobilization the rectum, the disinfected Cable Tie was introduced into the pelvic cavity.then the rectum was bundled by the tie which was much easier as the tie is auto-locked. pulling the tie and the rectum would be explored clearly, and then the endoscopic linear cutter was introduced to transect the rectum. the tie made the rectum folded not applanate, that the cutter was able to transect the rectum easily and with less reloader.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, 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

  • rectal cancer patients;
  • the tumor located 5-12cm from the anal verge, that an anterior resection was needed.
  • the cancer has no organ invasion.

排除标准

  • patients refuse

结局指标

主要结局

the number of reloads during the surgery

时间窗: during the operation

the number of reloads during the surgery

ratio of patients with 2 or more reloads

时间窗: during the operation

ratio of patients with 2 or more reloads

次要结局

  • operation duration time(during the operation)
  • rate of anastomotic leaks(3 month after the surgery)
  • complication rate(3 month after the surgery)

研究者

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

Ziqiang Wang,MD

professor

West China Hospital

研究点 (1)

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