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临床试验/NCT04357171
NCT04357171已完成不适用

Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer

Russian Society of Colorectal Surgeons0 个研究点目标入组 202 人开始时间: 2012年1月14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
202
主要终点
The rate of readmissions due to severe dehydratation

研究概览

简要总结

The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.

This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.

详细描述

Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.

The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.

The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.

In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.

Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mid- and low rectal cancer
  • No previous stoma formation
  • Informed consent for participation

排除标准

  • Patients lost during the follow-up
  • Refusal of the patient from further participation in the study
  • Inability of stoma formation

结局指标

主要结局

The rate of readmissions due to severe dehydratation

时间窗: 6 weeks

The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting

次要结局

  • The rate of early postoperative complications after stoma closure operation(3 months after stoma closure)
  • Time with stoma(5 years)
  • Early postoperative complications rate(30 days after the initial procedure)
  • Late postoperative complications rate(starting on 31st day and within 6 months in late postoperative period after the initial procedure)
  • Overall quality of life(6 and 12 months after the initial procedure)

研究者

发起方
Russian Society of Colorectal Surgeons
申办方类型
Other
责任方
Sponsor

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