Randomized Controlled Trial Comparing the Efficiency of the Bipolar Energy Compared With the Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Bleeding abundance
研究概览
简要总结
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.
详细描述
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.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Bleeding abundance
时间窗: 12 months after surgical intervention
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
次要结局
- Per-operative complications rate(From the entry till the removal of the hysteroscope from the body - ambulatory surgery (max one day))
- Bleeding abundance(6 months after surgical intervention)
- Post-operative complications rate(6 weeks after the surgical intervention)
- Re-do surgery rate(12 months after the surgical intervention)
- Surgery duration(From the entry till the removal of the hysteroscope from the body -ambulatory surgery (max one day))
研究者
Andre Nazac
Head of clinic
Brugmann University Hospital