MenorrhagiaNCT02642926
Comparison of the Efficiency of Bipolar Energy Versus Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
A study testing Monopolar current and Bipolar current in people with Menorrhagia, run by Brugmann University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Monopolar current and Bipolar current
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Efficiency of the Bipolar Energy Compared With the Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
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.
Read the 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.
- Conditions
- Menorrhagia
- Being tested
- Monopolar current, Bipolar current
- Keywords
- menorrhagia, higham PBAC score, endometrial ablation, bipolar energy, monopolar energy
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar currentProcedure or surgery
Hysteroscopic surgical treatment of menorrhagia by use of monopolar current
Bipolar currentProcedure or surgery
Hysteroscopic surgical treatment of menorrhagia by use of bipolar current
| Study group | Role | What they receive |
|---|---|---|
| Monopolar endoscopic endometrial ablation | Active comparator | Not described Receives: Procedure: Monopolar current |
| Bipolar endoscopic endometrial ablation | Experimental | Not described Receives: Procedure: Bipolar current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding abundance
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
Measured: 12 months after surgical intervention
Secondary outcomes (5)
Bleeding abundance
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 weeks after the surgical intervention
Re-do surgery rate
Re-do surgery rate, because of hysteroscopic treatment failure
Measured: 12 months after the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Nazac, Brugmann University Hospital
- Investigators
- André Nazac, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642926
- Sponsor's protocol ID
- CHUB-Monobimen
- Status last verified
- Aug 2016
- First submitted
- 11 Dec 2015
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Duckitt K. Menorrhagia. BMJ Clin Evid. 2015 Sep 18;2015:0805.
PubMed 26382038Higham 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.
PubMed 2400752Fergusson 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.
PubMed 24288154Boe 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.
PubMed 16521686Brumsted 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.
PubMed 8566254Mayor 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.
PubMed 17255588Berg 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.
PubMed 18371962
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Efficiency of the Bipolar Energy Compared With the Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
- ClinicalTrials.gov ID
- NCT02642926
- Acronym / sponsor ID
- CHUB-Monobimen
- Conditions
- Menorrhagia
- Keywords
- menorrhagia, higham PBAC score, endometrial ablation, bipolar energy, monopolar energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monopolar endoscopic endometrial ablation | Active comparator | Procedure: Monopolar current |
| Bipolar endoscopic endometrial ablation | Experimental | Procedure: Bipolar current |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monopolar currentHysteroscopic surgical treatment of menorrhagia by use of monopolar current | Procedure or surgery | Monopolar endoscopic endometrial ablation |
| Bipolar currentHysteroscopic surgical treatment of menorrhagia by use of bipolar current | Procedure or surgery | Bipolar endoscopic endometrial ablation |
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.
5 secondary outcomes
Bleeding abundance
Time frame: 6 months after surgical intervention
Surgery duration
Time frame: From the entry till the removal of the hysteroscope from the body -ambulatory surgery (max one day)
Per-operative complications rate
Time frame: From the entry till the removal of the hysteroscope from the body - ambulatory surgery (max one day)
Post-operative complications rate
Time frame: 6 weeks after the surgical intervention
Re-do surgery rate
Time frame: 12 months after the surgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Background: PubMed 26382038Duckitt K. Menorrhagia. BMJ Clin Evid. 2015 Sep 18;2015:0805.
- Background: PubMed 2400752Higham 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.
- Background: PubMed 24288154Fergusson 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.
- Background: PubMed 16521686Boe 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.
- Background: PubMed 8566254Brumsted 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.
- Background: PubMed 17255588Mayor 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.
- Background: PubMed 18371962Berg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Nazac, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar current and Bipolar current in people with Menorrhagia, run by Brugmann University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding abundance (time frame: 12 months after surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642926, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.