Comparison of the Efficiency of Bipolar Energy Versus Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
Primary Purpose
Menorrhagia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Monopolar current
Bipolar current
Sponsored by
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring menorrhagia, higham PBAC score, endometrial ablation, bipolar energy, monopolar energy
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
Sites / Locations
- CHU Bicêtre, Kremlin Bicêtre (A.P.H.P)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Monopolar endoscopic endometrial ablation
Bipolar endoscopic endometrial ablation
Arm Description
Outcomes
Primary Outcome Measures
Bleeding abundance
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
Secondary Outcome Measures
Bleeding abundance
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
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.
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.
Post-operative complications rate
Number of complications that occured after the surgery
Re-do surgery rate
Re-do surgery rate, because of hysteroscopic treatment failure
Full Information
NCT ID
NCT02642926
First Posted
December 11, 2015
Last Updated
August 5, 2016
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02642926
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
menorrhagia, higham PBAC score, endometrial ablation, bipolar energy, monopolar energy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monopolar endoscopic endometrial ablation
Arm Type
Active Comparator
Arm Title
Bipolar endoscopic endometrial ablation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Monopolar current
Intervention Description
Hysteroscopic surgical treatment of menorrhagia by use of monopolar current
Intervention Type
Procedure
Intervention Name(s)
Bipolar current
Intervention Description
Hysteroscopic surgical treatment of menorrhagia by use of bipolar current
Primary Outcome Measure Information:
Title
Bleeding abundance
Description
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
Time Frame
12 months after surgical intervention
Secondary Outcome Measure Information:
Title
Bleeding abundance
Description
Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.
Time Frame
6 months after surgical intervention
Title
Surgery duration
Description
Surgery duration time, measured in minutes. The surgery will be performed according to the standard of care of the hospital, in ambulatory mode.
Time Frame
From the entry till the removal of the hysteroscope from the body -ambulatory surgery (max one day)
Title
Per-operative complications rate
Description
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.
Time Frame
From the entry till the removal of the hysteroscope from the body - ambulatory surgery (max one day)
Title
Post-operative complications rate
Description
Number of complications that occured after the surgery
Time Frame
6 weeks after the surgical intervention
Title
Re-do surgery rate
Description
Re-do surgery rate, because of hysteroscopic treatment failure
Time Frame
12 months after the surgical intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Nazac, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bicêtre, Kremlin Bicêtre (A.P.H.P)
City
Bicêtre
ZIP/Postal Code
94270
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26382038
Citation
Duckitt K. Menorrhagia. BMJ Clin Evid. 2015 Sep 18;2015:0805.
Results Reference
background
PubMed Identifier
2400752
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.
Results Reference
background
PubMed Identifier
24288154
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.
Results Reference
background
PubMed Identifier
16521686
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.
Results Reference
background
PubMed Identifier
8566254
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.
Results Reference
background
PubMed Identifier
17255588
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.
Results Reference
background
PubMed Identifier
18371962
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.
Results Reference
background
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Comparison of the Efficiency of Bipolar Energy Versus Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia
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