Comparison of the Efficiency of Bipolar Energy Versus Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia

Study Overview
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Brief Summary
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Since the development a few years ago of bipolar energy in the surgery by operative hysteroscopy, the hysteroscopic treatment of menorrhagia by endometrial ablation can be achieved either by the use of monopolar or bipolar current, in parallel with other techniques labelled as 'second generation' (microwave, radio frequency, thermal destruction ...) treating the uterine cavity. It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the success rate after bipolar endometrial ablation are poor and there is currently no recommendation as to the choice of technique to use. No prospective assessment exists to date in the literature to compare the difference in efficacy on bleedings when using monopolar or bipolar current. The goal of this study is to compare these two energies, by measuring the amount of bleeding calculated by the Higham score 12 months after the intervention.

Detailed Description
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Menorrhagia are one of the main symptoms that are managed in Gynecology. The evaluation of the volume of menorrhagia is performed by a PBAC score (pictorial bleeding assesment chart). The one described by Higham allows to quantify and qualify periods as being hemorrhagic when the score is above 150.The surgical treatment of choice has long been hysterectomy. Many studies evaluating the efficacy, safety and cost of different techniques were performed. A recent review of the literature identified eight randomized clinical trials that showed a slight advantage to the hysterectomy, in comparison with the ablation of the endometrium, for the improvement of symptoms and the patient's satisfaction. Hysterectomy is however associated with a longer surgery duration and a longer recovery period. Moreover, most adverse events (major and minor), were significantly more common after hysterectomy. A retrospective study examined the long-term results of hysteroscopic endometrectomies. During the monitoring, carried out over 4 to 10 years, menorrhagia stopped in 83.4% of cases. Over the same period, 16.6% of the patients had to undergo hysterectomy because menorrhagia had returned. In terms of cost, one study showed that the total direct and indirect cost of an hysteroscopic treatment of menorrhagia was significantly lower than that of hysterectomies.Endometrial ablation thus offers an alternative to hysterectomy as surgical treatment of menorrhagia. Several instances and authors recommend this surgery as first line when medical treatment has failed.Initially, the hysteroscopic surgical treatment of menorrhagia was performed by monopolar endoscopic ablation, which requires the use of glycine as a distension medium. Complications proper to the monopolar ablation were described. Because of these complications, the use of bipolar energy has been developped since several years. Other techniques known 2nd generation techniques have emerged: use of microwave, radio frequency, thermal destruction of the endometrium. They are all comparable in efficiency with a success rate of around 70% with the disadvantage of not having a comprehensive histology and be much more expensive. This diminishes their use because of the cost of purchase of the device. Although hysteroscopic bipolar ablation is now a routine technique, there are until now no studies in the literature comparing the efficacy of treatment when using monopolar or bipolar energy, for the endometrial resection by hysteroscopy, for menorrhagia management.The goal of this study is to compare these two energies, by measuring the amount of bleeding calculated by the Higham score 12 months after the intervention.

Official Title
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Randomized Controlled Trial Comparing the Efficiency of the Bipolar Energy Compared With the Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia

Conditions
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Menorrhagia

Intervention / Treatment
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* Procedure: Monopolar current
* Procedure: Bipolar current


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from menorrhagia Higham score > 150 No further pregnancy wish Failure of a former medical treatment Patients consulting a surgeon, for a standard of care surgical intervention Exclusion Criteria: Pregnant women Menopausal women Patient under anticoagulant treatment, type anti-vitamin K (AVK) Patient with a malign endometrial pathology Patient with one or several known endo-uterine synechia Uterine malformation Active and uncured infection

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Monopolar endoscopic endometrial ablation<br> | Procedure: Monopolar current<br>* Hysteroscopic surgical treatment of menorrhagia by use of monopolar current<br>|
| Experimental: Bipolar endoscopic endometrial ablation<br> | Procedure: Bipolar current<br>* Hysteroscopic surgical treatment of menorrhagia by use of bipolar current<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding abundance | Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient. | 12 months after surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding abundance | Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient. | 6 months after surgical intervention | 
| Surgery duration | Surgery duration time, measured in minutes. The surgery will be performed according to the standard of care of the hospital, in ambulatory mode. | From the entry till the removal of the hysteroscope from the body -ambulatory surgery (max one day) | 
| Per-operative complications rate | Number of complications that occured during the surgery duration. The surgery will be performed according to the standard of care of the hospital, in ambulatory mode. | From the entry till the removal of the hysteroscope from the body - ambulatory surgery (max one day) | 
| Post-operative complications rate | Number of complications that occured after the surgery | 6 weeks after the surgical intervention | 
| Re-do surgery rate | Re-do surgery rate, because of hysteroscopic treatment failure | 12 months after the surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menorrhagia, higham PBAC score, endometrial ablation, bipolar energy, monopolar energy