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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Symptomatic Submucosal Myoma

Intervention / Treatment
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* Procedure: Hysteroscopic resection with bipolar energy
* Procedure: Hysteroscopic resection with monopolar energy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic (menorrhagia or primary/secondary infertility) with pregnancy wishes One submucosal myoma, type 0 to Type II, accessible to a hysteroscopic surgery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bipolar energy<br>Hysteroscopic resection of symptomatic sub mucosal myomas with the use of bipolar energy | Procedure: Hysteroscopic resection with bipolar energy<br>* Hysteroscopic resection with bipolar energy<br>|
| Active Comparator: Monopolar energy<br>Hysteroscopic resection of symptomatic sub mucosal myomas with the use of monopolar energy | Procedure: Hysteroscopic resection with monopolar energy<br>* Hysteroscopic resection with monopolar energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine adhesions rate | 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. | 6 weeks after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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submucosal myoma, hysteroscopic resection, bipolar energy, monopolar energy