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临床试验/NCT01167296
NCT01167296已完成4 期

Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

Shin Kong Wu Ho-Su Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
2
主要终点
intrauterine bacteria count

研究概览

简要总结

To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.

详细描述

Background:Intrauterine adhesion (IUA) can cause infertility. Hysteroscopic surgery can effectively treat most IUA. In order to prevent adhesion reformation after surgery, most gynecologists will prescribe high-dose estrogen to stimulate endometrial growth, and leave an IUD or a Foley catheter in uterus for 1-3 months. But neither IUD nor Foley catheter conform to the uterine cavity. The Cook balloon uterine stent was designed to fit into the uterine cavity. But it was designed to tamponade the uterus to prevent post-operative uterine bleeding. It's not known if it can be left in the uterus for 30 days.

Study Design:Uterine culture was done before hysteroscopic surgery, and 30 days later. The study group comprise patients with uterine stent; the control group comprise patients who undergo hysteroscopic surgeries but without uterine stent.

Method:Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity. The removed uterine stent was sent for bacterial culture too. The same procedures are done for patients with and without uterine stent. The bacterial counts will be compared before and after hysterosocpic surgeries, and between the two groups of patients.

Effect:If leaving the uterine stent in the uterus up to 30 days does not cause bacteria to grow, we can be confident to leave the stent for 30 days.

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

性别
Female
接受健康志愿者

入选标准

  • intrauterine adhesion women

排除标准

  • allergic to Cook balloon uterine stent

结局指标

主要结局

intrauterine bacteria count

时间窗: one year

次要结局

  • intrauterine adhesion(one year)

研究者

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

Yu-Hung Lin

MD

Shin Kong Wu Ho-Su Memorial Hospital

研究点 (2)

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