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临床试验/NCT01464528
NCT01464528Unknown早期 1 期

Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Hadassah Medical Organization0 个研究点目标入组 10 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
10
主要终点
Patient satisfaction following gel application

研究概览

简要总结

Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.

详细描述

Operations in the uterus are currently possible using a hysteroscopic approach. Intrauterine procedures include; polypectomy, myomectomy, removal of lost IUD,removal of a septum and more. One serious though rare complication of operative hysteroscopy is the development of intra-uterine adhesions. Such adhesions, also known as asherman's syndrome, can cause serious consequences such as infertility and miscarriage. The hypothesis is that the removal of the endometrium and the exposure of ra uterine wall to each other can cause attachment and adhesions. the treatment is to mechanically break the adhesion. recurrence is however common. There currently are no methods to prevent adhesions following curettage or hysteroscopy. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery. At a later research, the efficacy of barrier gel will be measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • age 18 year old and over
  • need of hysteroscopic surgery

排除标准

  • preoperative fever or infection
  • malignancy
  • previous PID
  • contraindications for anesthesia
  • pregnancy
  • under 18 year old
  • not able to read and/or understand informed consent
  • taking any medicine other than oral contraceptives

研究组 & 干预措施

Hyaluronan

Active Comparator

Use of hyaluronic acid gel

干预措施: Hyaluronan (Drug)

结局指标

主要结局

Patient satisfaction following gel application

时间窗: 2 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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