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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary:

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.


Detailed Summary:

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.

Since several years, the use of the bipolar energy for hysteroscopic resection has been developped.
Sponsor: Brugmann University Hospital

Current Primary Outcome: uterine adhesions rate [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pregnancy rate [ Time Frame: 18 months after surgery ]
    Number of evolutive pregnancies - phone contact 18 months after surgery
  • Spontaneous abortion rate [ Time Frame: 18 months after surgery ]
    Number of spontaneous abortions - phone contact 18 months after surgery
  • Surgery duration [ Time Frame: From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day ]
    Duration of the surgical intervention
  • Per-surgery complications rate [ Time Frame: From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day ]
    Complications rate during the surgery duration
  • Post-surgery complications rate [ Time Frame: 6 weeks after surgery ]
    Post-surgery complications rate, measured at the diagnostic hysteroscopic visit performed 6 weeks after surgery.


Original Secondary Outcome: Same as current

Information By: Brugmann University Hospital

Dates:
Date Received: January 19, 2016
Date Started: November 2012
Date Completion: March 2018
Last Updated: March 24, 2017
Last Verified: March 2017