Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- fallopian tube obstruction
研究概览
简要总结
Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.
详细描述
The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.
All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.
Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.
Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope
排除标准
- •Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study
研究组 & 干预措施
isoamyl2cyanoacrylate
Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter
干预措施: Isoamyl-2-cyanoacrylate (Drug)
结局指标
主要结局
fallopian tube obstruction
时间窗: from one day to four weeks
assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements.
次要结局
- degree and extend of inflammation in the fallopian tubes(from one day to four weeks)
研究者
Mohamed I Amer
Professor
Ain Shams University