Clinical trial NCT02642926: Comparison of the Efficiency of Bipolar Energy Versus Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
Official title: Randomized Controlled Trial Comparing the Efficiency of the Bipolar Energy Compared With the Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Keywords: menorrhagia
higham PBAC score
endometrial ablation
bipolar energy
monopolar energy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding abundance
timeFrame: 12 months after surgical intervention
Secondary outcomes:
measure: Bleeding abundance
timeFrame: 6 months after surgical intervention
measure: Surgery duration
timeFrame: From the entry till the removal of the hysteroscope from the body -ambulatory surgery (max one day)
measure: Per-operative complications rate
timeFrame: From the entry till the removal of the hysteroscope from the body - ambulatory surgery (max one day)
measure: Post-operative complications rate
timeFrame: 6 weeks after the surgical intervention
measure: Re-do surgery rate
timeFrame: 12 months after the surgical intervention
Other outcomes:
Locations:
city: Bicêtre
country: France
facility: CHU Bicêtre, Kremlin Bicêtre (A.P.H.P)
Study officials:
affiliation: CHU Brugmann
name: André Nazac, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duckitt K. Menorrhagia. BMJ Clin Evid. 2015 Sep 18;2015:0805.
citation: Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.
citation: Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013 Nov 29;(11):CD000329. doi: 10.1002/14651858.CD000329.pub2.
citation: Boe Engelsen I, Woie K, Hordnes K. Transcervical endometrial resection: long-term results of 390 procedures. Acta Obstet Gynecol Scand. 2006;85(1):82-7. doi: 10.1080/00016340500424314.
citation: Brumsted JR, Blackman JA, Badger GJ, Riddick DH. Hysteroscopy versus hysterectomy for the treatment of abnormal uterine bleeding: a comparison of cost. Fertil Steril. 1996 Feb;65(2):310-6. doi: 10.1016/s0015-0282(16)58091-1.
citation: Mayor S. NICE says hysterectomy must be last option for heavy menstrual bleeding. BMJ. 2007 Jan 27;334(7586):175. doi: 10.1136/bmj.39105.376412.DB. No abstract available.
citation: Berg A, Sandvik L, Langebrekke A, Istre O. A randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil Steril. 2009 Apr;91(4):1273-8. doi: 10.1016/j.fertnstert.2008.01.083. Epub 2008 Apr 18.