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临床试验/NCT02661087
NCT02661087撤回不适用

MONOBISY: Randomized Controlled Trial Comparing Intra Uterine Synechiae Occurence Using Bipolar Energy Compared With Monopolar Energy in Myoma Resection on Women Having Menorraghia and/or Infertility

Brugmann University Hospital4 个研究点 分布在 2 个国家开始时间: 2017年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
uterine adhesions rate

研究概览

简要总结

Since the development in the last few years of the bipolar energy in the surgery by hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by use of either monopolar or bipolar current.

It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the adhesion rate and fertility after the use of bipolar energy during the surgery are poor, and there is currently no recommendation as to the choice of technique to use. The main purpose of this study is to compare the rate of uterine adhesions six weeks after the surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.

详细描述

Uterine fibroids are detected in many cases of excessive bleeding or consultation for primary or secondary infertility. When they are of the submucosal type, they require a surgical treatment by hysteroscopy. The hysteroscopic resection of submucosal fibroids described by Neuwirth and Amin in 1976 allowed to reduce the morbidity, the length of hospital stay and the cost of the therapeutic treatment, with a satisfactory rate of functional successes.

The surgical hysteroscopic treatment of symptomatic submucosal myoma was performed initially by a monopolar endoscopic resection. This required a resection using glycine as a distension medium, essential for the conduction of monopolar current.

Complications proper to the monopolar resection have been described and are now well known. The first specific complication is the TURP syndrome, linked to the reabsorption of the glycine byproducts of the distensium medium. It can cause hyponatremia and lead to a cerebral edema. This complication can be prevented by limiting the duration of the intervention to 45 minutes and constantly monitoring the input-output balance.

The second specific complication is related to the diffusion of heat that can damage to surrounding healthy tissue and increase the risk of uterine adhesions. These adhesions are the source of menstrual disorders like hypomenorrhea or amenorrhea, infertility or a recurrent miscarriages.

For over 20 years, several approaches have been proposed to reduce the occurrence of postoperative adhesions. However, their results are either not convincing, either in need of confirmation.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Symptomatic (menorrhagia or primary/secondary infertility) with pregnancy wishes
  • One submucosal myoma, type 0 to Type II, accessible to a hysteroscopic surgery

排除标准

  • Several submucosal myomas
  • Pregnant woman
  • Patient under anticoagulating treatment (anti-vitamin K-type)
  • Patient with a malignant endometrial pathology
  • Patient having one or more endo-uterine synechiae
  • Myoma larger than 5 cm
  • Uterine malformation
  • Active infection, not healed
  • Refusal to participate in the Protocol

结局指标

主要结局

uterine adhesions rate

时间窗: 6 weeks after surgery

The main goal of this study is to compare the rate of uterine adhesions six weeks after the hysteroscopic surgical treatment of sub mucosal uterine myomas, in a group where bipolar energy is used versus a group where monopolar energy is used during the surgery. Outcome measured at the diagnostic hysteroscopic visit, 6 weeks after surgery.

次要结局

  • Per-surgery complications rate(From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day)
  • Spontaneous abortion rate(18 months after surgery)
  • Surgery duration(From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day)
  • Pregnancy rate(18 months after surgery)
  • Post-surgery complications rate(6 weeks after surgery)

研究者

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

Andre Nazac

Head of Clinic

Brugmann University Hospital

研究点 (4)

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