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临床试验/NCT04633382
NCT04633382Unknown不适用

JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Vitebsk State Medical University0 个研究点目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Reduction of bed-days

研究概览

简要总结

The aim of the study is to improve the immediate results after reconstructive and restorative operations on the biliary tract by substantiating the management of the perioperative period on the principles of "enhanced recovery after surgery".

详细描述

A prospective randomized study on the effect of fast-track surgery on the immediate postoperative results after various reconstructive and restorative operations on the bile ducts. In the Department of Surgical Hepatology and Transplantation, a prospective randomized study will include patients (about 50) with planned reconstructive and restorative operations on the bile ducts for malignant and benign diseases of the bile ducts.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with malignant diseases of the biliary tract (cholangiocarcinoma):
  • tumor resectability 1.
  • distant metastases
  • carcinomatosis
  • perforation of the tumor and peritonitis
  • sprouting into adjacent organs and tissues (locally advanced cancer)
  • total adhesion process in the abdominal cavity (after previous operations). 1.
  • Planned reconstructive surgery on the biliary tract.
  • Patients with benign biliary tract pathology. 2.
  • Planned reconstructive or restorative surgery on the biliary tract for the following diseases:
  • choledocholithiasis
  • Mirizzi syndrome
  • cysts of the common bile duct
  • strictures of the common bile duct
  • injuries to the bile ducts
  • adenoma and stricture of the OBD

排除标准

  • Scale ASA> III (severe concomitant cardiovascular pathology).
  • Palliative reconstructive surgery.
  • Previously performed operations on the bile ducts (up to 1 month).

结局指标

主要结局

Reduction of bed-days

时间窗: 1 week

Improvement of basic health indicators, absence of complications, reduction of bed days

次要结局

未报告次要终点

研究者

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

Yury Arlouski

Associate professor, MD, PhD

Vitebsk State Medical University

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