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A Study to Compare the Effectiveness of Two Different Outpatient Endometrial Ablation Techniques Used for Heavy Periods

2014-08-27 03:13:40 | BioPortfolio

Summary

STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM endometrial ablation?

Description

Heavy menstrual bleeding (HMB) or 'menorrhagia' is a common condition with a major impact on health-related quality of life and health resource utilization in both primary and secondary care. In over 50% of cases no organic pathology is present and the term dysfunctional uterine bleeding (DUB) is used. First line treatment of DUB is medical and where this fails, surgery is indicated using either minimally invasive approaches (endometrial ablation) or major surgery (hysterectomy). Endometrial ablation has been extensively evaluated against the gold standard of hysterectomy and shown to be effective and associated with fewer complications. The technique involves destroying the entire, or a substantial proportion, of the endometrium thereby preventing cyclical endometrial regeneration and suppressing or reducing menstrual blood loss. Recent advances in endoscopic technology have resulted in the development of miniature, automated ablative systems (so called 'second generation devices'), which are easy to use, safe and obviate the need for routine unpleasant and expensive endometrial preparatory drugs10. Moreover, these devices have the potential to be routinely used in the outpatient or 'office' setting without the need for general anaesthesia. This approach is increasingly being advocated as it expands patient choice and potentially increasing safety and cost-effectiveness of treatment.

The three most commonly employed and evaluated ablative devices are ThermachoiceTM III thermal balloon ablation (Gynecare Inc, Somerville, NJ, USA), Microwave endometrial ablation (Microsulis plc, Waterlooville, Hampshire, UK) and NovaSureTM impedance-controlled endometrial ablation (Cytyc, Marlborough, MA USA). All appear to have comparable efficacy when employed as an inpatient under general anaesthesia in terms of patient satisfaction and life quality although data on direct head to head comparisons of these procedures when performed in an outpatient environment are scarce. All techniques have been employed without the need for general anaesthesia11,16-19, but only ThermachoiceTM has been reported in an outpatient setting11, without the need for formal theatre facilities or conscious sedation. The Microwave technique necessitates significant dilatation of the cervix that limits its potential for use in an outpatient setting in contrast to ThermachoiceTM and NovaSureTM10.

The newer NovasureTM system is more effective than ThermachoiceTM because inpatient studies report a higher rate of amenorrhoea (cessation of menstrual periods - 43% versus 8%). Moreover, NovaSureTM may be a better technique for use in conscious patients in an outpatient setting as it is a shorter procedure (1.5 versus 8 minutes) and associated with less post-operative pain16,19 but it does require a greater degree of potentially painful cervical dilatation10. There is thus a need for a randomised trial to compare the effectiveness and acceptability of ThermachoiceTM and NovaSureTM endometrial ablation in an outpatient setting for the treatment of menorrhagia.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Menorrhagia

Intervention

NovaSure, thermachoice

Status

Completed

Source

Birmingham Women's NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:40-0400

Clinical Trials [35 Associated Clinical Trials listed on BioPortfolio]

Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia

A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life is...

Efficacy and Safety Study of XP12B in Women With Menorrhagia

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

- The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in th...

Safety Study of XP12B in Women With Menorrhagia

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Mirena in Idiopathic Menorrhagia

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of ...

PubMed Articles [8 Associated PubMed Articles listed on BioPortfolio]

Evaluation of NovaSure global endometrial ablation in symptomatic adenomyosis: A longitudinal study with a 36 month follow-up.

To evaluate the efficacy of NovaSure radiofrequency global endometrial ablation (GEA) in adenomyosis.

Successful treatment of severe menorrhagia at menarche with recombinant factor VIIa in an adolescent girl with type III von Willebrand's disease.

: Type III von Willebrand's disease (vWD) is an inherited bleeding disorder, which is frequently associated with menorrhagia in women. Treatment options include antifibrinolytics, desmopressin, von Wi...

Naturopathic Medicine for the Management of Endometriosis, Dysmenorrhea, and Menorrhagia: A Content Analysis.

To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.

Burkitt's Lymphoma Presenting as Menorrhagia and a Vaginal Mass in an Adolescent.

Menorrhagia is a common gynecologic complaint among adolescents, which rarely is secondary to malignancy. Burkitt's lymphoma can mimic gynecologic malignancy, however it is rarely seen in adolescents....

Additional non-contraceptive effects of contraception: CNGOF Contraception Guidelines.

Hormonal and intrauterine contraceptive methods provide women with highly efficient protection against undesired pregnancy. Additional non-contraceptive effects are now well documented. Combined hormo...

Medical and Biotech [MESH] Definitions

Excessive uterine bleeding during MENSTRUATION.

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