Demonstrate that HydroThermAblation is equally effective compared to Novasure in improving quality of life, satisfaction, amenorrhoea and complications.
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life, measured by questionnaires filled in by the patient
pre-operative, 4 weeks, 6 and 12 months after treatment. Questionnaires contain
Short Form 36 and a structured clinical history questionnaire. Patients
satisfaction is measured by using a visual analogue scale.
Secondary outcome
Amenorrhoea. Using a pictorial chart in every questionnaire.
Background summary
Dysfunctionale uterine bleeding is a frequent problem in premenopausal women.
This has consequences for general well being. Women suffering from menorrhagia
often report limitations in their physical, social and emotional functioning. A
hysterectomy was often necessary to relieve these complaints. However, this is
a major operation associated with morbidity and even mortality. An endometrial
ablation has a much lower morbidity and mortality rate and is in a lot of cases
enough treatment for menorrhagia.
There are several endometrial ablation techniques, 1th and 2nd generation
devices. They have very different techniques with their own
(dis-)advantages.This study was designed to evaluate the safety and
effectiveness of the HydroThermAblation compared with Novasure in eliminating
menorrhagia.
Study objective
Demonstrate that HydroThermAblation is equally effective compared to Novasure
in improving quality of life, satisfaction, amenorrhoea and complications.
Study design
Randomised controlled trial, HydroThermAblation versus Novasure
Intervention
HydroThermAblation or Novasure ablation of endometrial tissue.
HydroThermaAblation system uses hot saline ablation under direct hysteroscopic
view. Novasure consists of a 3-dimensional bipolar impedance controlled system.
Study burden and risks
For patients participating in the trial there are no additive risks. If a
patient chooses for an endometrial tissue ablation, she should be aware of the
operation risks.
Postbus 7777
5500 MB Veldhoven
Nederland
Postbus 7777
5500 MB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Dysfunctional uterine bleeding
Uterine sound measurements of 6.0-12.0 cm
Failed, contraindicated or intolerance to conservative (medical) therapy
Exclusion criteria
Desire to have children or preserve fertility
Abnormal/ obstructed uterine cavity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12863.015.06 |