Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001404415
Ethics application status
Approved
Date submitted
19/09/2016
Date registered
10/10/2016
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hysteroscopic Morcellator Versus Electrosurgical Resection for Submucosal Leiomyoma
Scientific title
A Randomised Controlled Trial of Hysteroscopic Morcellation Versus Electrosurgical Resection for Submucosal Leiomyomas in Women With Abnormal Uterine Bleeding
Secondary ID [1] 289339 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Submucosal Leiomyoma
 298956 0
Uterine Fibroids 298957 0
Condition category
Condition code
Renal and Urogenital 299028 299028 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hysteroscopic Morcellation

The MyoSure (Registered Trademark) is a 2nd-generation hysteroscopic morcellation device. It aims to remove leiomyomas in one single insertion of a hysteroscope into the uterus . The device uses suction-based, mechanical energy to rotate a morcellating system and concurrently aspirate tissue strips. The uterus is distended with saline via a small channel in the hysteroscope.
This procedure, performed by the surgeon (consultant or supervised trainee), is intended to reduce risks of (1) traumatic injury to uterus and inadvertent fluid overload compared to traditional procedures, by reducing operation time; (2) thermal injury compared to thermal ablation techniques.
Duration of this procedure is between 10 to 60 minutes.
Intervention code [1] 294900 0
Treatment: Devices
Comparator / control treatment
Monopolar Electrosurgical Resection

Monopolar electrosurgical resection is the traditional surgical method for removal of leiomyoma, performed by the surgeon (consultant or supervised trainee) using a resectoscope consisting of a visual source (telescope); a monopolar radiofrequency energy source; and fitted with an external sheath which facilitates constant flow of distension fluid (glycine) for distending the uterine cavity.
Resected tissue strips are created as the case proceeds, and needs to be periodically removed from the uterine cavity to enhance visualisation. The need for removal of hysteroscope potentiates cervical trauma. Furthermore, increased operation time is especially significant in removal of larger myomas as it increases potential for fluid overload, traumatic injury to the uterus and incomplete removal of fibroid. Additionally, use of glycine, a hypotonic, non-conductive media, increases the risk of hyponatraemia and associated electrolyte disturbances, which may lead to fatal outcomes.

This duration of this procedure takes between 10 to 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 298489 0
Cost-utility of hysteroscopic morcellation vs. monopolar electrosurgical resection: Cost minimisation study of two devices in an operating room setting, so as to determine opportunities for direct and indirect savings in a public health setting

We will assess total theatre time, opportunity cost and complete revision of pre-operative, intra-operative and post-operative consumables and reusable items. Post-operative visits, incidental medications, re-interventions or complications will be coded and cost-calculated according to MBS schedules in a prospective manner.
Timepoint [1] 298489 0
Intra-operative
Secondary outcome [1] 324352 0
Ease of use of device: Investigate ease of use of hysteroscopic morcellation vs. electrosurgical resection, among surgeons of different skill levels (Trainee, Fellow, Consultant)

Ease of use of the device will be assessed using a verbal descriptor scale.
Timepoint [1] 324352 0
Intra-operative
Secondary outcome [2] 324353 0
Completeness of resection: Determine need for cessation of operation due to fluid deficit point being reached, and as a result, the completeness of resection by the two devices.

Completness of resection is reported by the surgeon following the procedure as a fraction of the remaining pathology.
Timepoint [2] 324353 0
Intra-operative
Secondary outcome [3] 324354 0
Number of adverse events: Determine frequency, severity and significance of adverse events which occur with both devices.

Adverse events, such as bleeding, fluid overload, electrolyte imbalance, infection, and vaginal discharge, are assessed intra- and post-operatively and are recorded and tracked in the specifically designed case report form for this study. These will be assessed by in-person contact, searching patient case notes and communication with the local medical officer.
Timepoint [3] 324354 0
Continuous recording of adverse events will begin at the beginning of the procedure, and continue for at least 6 months (until the 6 month follow-up).
Secondary outcome [4] 324355 0
Cost-benefit analysis dependent on clinical outcome data following hysteroscopic morcellation vs. monopolar electrosurgical resection: Cost-effectiveness of clinical outcomes following hysteroscopic morcellation or monopolar electrosurgical resection; considering cost of post-operative care including re-presentation, follow-up consultation, treatment of complications/adverse events, need for repeat procedures
Timepoint [4] 324355 0
Cost-benefit will be assessed from patient's operation and continue post-operatively for at least 6 months.

Eligibility
Key inclusion criteria
- All symptomatic women requiring an elective hysteroscopic procedure for a suspected or ultrasound confirmed leiomyoma
- English speaking
- Over 18 years of age at time of surgery
- Women who understand the conditions of the study, and are willing to participate for the length of the prescribed term of follow-up
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant women
- Immuno-compromised women
- Current involvement in any other research project
- Women who are suspected to have a gynaecological malignancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved by contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/06/2016
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
162
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5870 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 5871 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 5872 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 13312 0
2031 - Randwick
Recruitment postcode(s) [2] 13313 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 293718 0
Charities/Societies/Foundations
Name [1] 293718 0
Australasian Gynaecological Endoscopy & Surgery Society (Research Scholarship)
Country [1] 293718 0
Australia
Primary sponsor type
University
Name
GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia
Address
Locked bag 2000
Barker St
Randwick, 2031 NSW
Country
Australia
Secondary sponsor category [1] 292655 0
None
Name [1] 292655 0
Address [1] 292655 0
Country [1] 292655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295150 0
South Eastern Sydney Local Health District EC00134
Ethics committee address [1] 295150 0
G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Enter via Edmund Blackett courtyard
Cnr High and Avoca Street Randwick NSW 2031
Ethics committee country [1] 295150 0
Australia
Date submitted for ethics approval [1] 295150 0
13/07/2015
Approval date [1] 295150 0
19/04/2016
Ethics approval number [1] 295150 0
15/169

Summary
Brief summary
One of the most common reasons for presentation to a gynaecologist is for abnormal uterine bleeding (AUB). Women suspected for leiomyomas clinically or on ultrasound evidence are likely to be recommended to have surgical treatment for their condition, since medical treatment is ineffective for this presentation.
Monopolar electrosurgical resection is frequently used in hysteroscopic removal of fibroids. Main complications include electrolyte disturbances and potential fatal outcomes due to use of hypotonic, non-conductive media (glycine) for uterine distension; and need for removal of the hysteroscope mid-procedure in order to clear the intrauterine cavity of debris, increasing operating time and potentiates cervical trauma.
The hysteroscopic morcellator (Myosure (registered trademark)) has become an increasingly used tool to remove submucosal leiomyomas, as well as other intra-uterine pathology such as retained placental remnants. This instrument operates in a normal saline medium, removing the risk of hyponatraemia second to excessive absorption, during mechanical resection and concurrent removal of the fibroid from the intra-uterine cavity. Risk to the patient of fluid overload due to intra-vascular or intra-peritoneal absorption of large quantities of saline may occur.
This study will compare the use of a mechanical hysteroscopic morcellator to monopolar electrosurgical hysteroscopic resection to remove submucosal leiomyomas in symptomatic women with AUB-L. We hypothesise that the hysteroscopic morcellator will allow for significantly faster resection of fibroids independent of surgical skill.
The primary outcome of the study will investigate cost minimisation of the two different devices in an operating room setting, and determine opportunities for direct and indirect savings in a public health setting. Secondary outcomes will include determining: (1) ease of use of device; (2) completeness of resection, in terms of cessation of operation due to fluid deficit point being reached; and (3) the number of adverse events.
This study is a prospective, randomised, single-blinded multi-centre clinical study. Women will be randomised to one of two study groups:
1. Intervention group: Resection of the leiomyoma with the hysteroscopic morcellator (Myosure (registered trademark)) and a normal saline distension medium.
2. Control group: Resection of the leiomyoma with a monopolar electrosurgical hysteroscopic resector with a glycine distension medium.
Randomisation will occur via a third-party randomisation service, and study participants only will be blinded with regards to group allocation.
A minimum of 162 participants to be enrolled over a 1-year recruitment period. All cases must satisfy the inclusion/exclusion criteria and will be followed for a minimum of 6 months after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55826 0
A/Prof Jason Abbott
Address 55826 0
School of Women's and Children's Health
Royal Hospital for Women
Barker St, Randwick NSW 2031
Country 55826 0
Australia
Phone 55826 0
+61293826733
Fax 55826 0
Email 55826 0
j.abbott@unsw.edu.au
Contact person for public queries
Name 55827 0
Dr Aaron Budden
Address 55827 0
Division of Gynaecology
Royal Hospital for Women
Barker St, Randwick NSW 2031
Country 55827 0
Australia
Phone 55827 0
+61422412013
Fax 55827 0
Email 55827 0
aaron.budden@health.nsw.gov.au
Contact person for scientific queries
Name 55828 0
A/Prof Jason Abbott
Address 55828 0
School of Women's and Children's Health
Royal Hospital for Women
Barker St, Randwick NSW 2031
Country 55828 0
Australia
Phone 55828 0
+61293826733
Fax 55828 0
Email 55828 0
j.abbott@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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