Symptomatic Submucosal Myoma Clinical Trial
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
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.
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.The advantage of this technique is to avoid glycine as distension medium and use
saline instead, hereby significantly reducing the risk of hyponatremia. It especially gives a
smaller heat diffusion, hereby limiting the damage to the healthy tissues nearby.
Although hysteroscopic bipolar resection of submucosal fibroids is now a routine technique,
there are to this date no studies in the literature comparing the use of monopolar and
bipolar energy in the hysteroscopic myomectomy.
The main objective of this study is to compare the rate of adhesions after resection of
uterine myomas, with the use of bipolar versus monopolar current. The secondary objective is
to evaluate the impact on subsequent fertility through the number of pregnancies and
miscarriages.
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