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临床试验/NCT03139149
NCT03139149招募中不适用

Comparison of Early Operative Treatment (12 h) and 48 h Conservative Treatment in Acute Small Bowel Obstruction

Pirogov Russian National Research Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Quantity of patients with obstruction release after conservative treatment

研究概览

简要总结

This study will compare the results of early surgery after 12 h conservative treatment and 48 h conservative treatment of adhesive small bowel obstruction.

详细描述

At the admission patients undergo abdomen x-ray, general and biochemical blood test and computer tomography (CT). After exclusion of indications for an emergency operation, patients are given a water-soluble contrast. Conservative treatment is carring out to 12 hours from admission. All patients with resolution of small bowel obstruction in 12 hours will be excluded from the research. Criteria for obstruction release of conservative treatment 1. No pain 2. Appearance of gas in the colon 3. Decrease of bloating 4. Contrast in the colon. After that, if obstruction is not resolved, randomization is performed. First group undergo surgery. Second group undergo conservative treatment with water-soluble contrast evaluation until 48 hours. In the second group surgery is performed if the conservative treatment is not effective. The results of early and late surgery and the results of conservative treatment in groups will be compared.

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
None

入排标准

年龄范围
17 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with adhesive small bowel obstruction

排除标准

  • Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics

结局指标

主要结局

Quantity of patients with obstruction release after conservative treatment

时间窗: in the 2nd group - 48 hours

No of patients with success of conservative treatment

次要结局

  • Readmission rate in conservative treatment and surgery(12 months)
  • 30 days mortality(30 days)
  • Complications rate(30 days)
  • Quantity of bowel resection(156 hours)

研究者

发起方
Pirogov Russian National Research Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander E. Tyagunov

MD. Prof

Pirogov Russian National Research Medical University

研究点 (1)

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