CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
Monopolar current +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02642926
NCT02642926N/ACompleted

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

Brugmann University Hospital·interventional·Posted Dec 30, 2015·Updated Aug 8, 2016

In Brief

A clinical study evaluating Monopolar current and Bipolar current for Menorrhagia. Completed, enrolled 98 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2015
Enrollment StartDec 1, 2012
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.5 years ago

Interventions

Monopolar currentprocedure

Hysteroscopic surgical treatment of menorrhagia by use of monopolar current

Bipolar currentprocedure

Hysteroscopic surgical treatment of menorrhagia by use of bipolar current