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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 Summary:

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 t
Sponsor: Brugmann University Hospital

Current Primary Outcome: Bleeding abundance [ Time Frame: 12 months after surgical intervention ]

Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Brugmann University Hospital

Dates:
Date Received: December 11, 2015
Date Started: December 2012
Date Completion:
Last Updated: August 5, 2016
Last Verified: August 2016