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Trial registered on ANZCTR


Registration number
ACTRN12615000035527
Ethics application status
Approved
Date submitted
10/11/2014
Date registered
19/01/2015
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Date results information initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Diathermy artefact in LLETZ specimens: A randomised controlled trial of high versus low power pure cut diathermy
Scientific title
Diathermy artefact in LLETZ specimens: A randomised controlled trial of high versus low power pure cut diathermy
Secondary ID [1] 285587 0
Nil
Universal Trial Number (UTN)
U1111-1163-6248
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-malignant cervical lesions
293423 0
Condition category
Condition code
Surgery 293699 293699 0 0
Surgical techniques
Cancer 293808 293808 0 0
Cervical (cervix)
Renal and Urogenital 293809 293809 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A small amount of cervical tissue (1-2cm) will be removed using a technique called 'Large Loop Excision of the Transformation Zone' (LLETZ). A LLETZ involves a wire loop which uses electricity to cut through the cervix removing the abnormal area.

Different settings are used on the machine to perform a LLETZ. We have chosen the lowest and highest settings used in our hospital. The lowest setting (50W) will be the control and the highest setting (100W) will be the intervention.

The procedure will be performed by the same surgeon who is a specialist in women's cancers.

The whole procedure takes only a few minutes.
Intervention code [1] 290537 0
Treatment: Surgery
Comparator / control treatment
Pure cut diathermy low power (50W)

Control group
Dose comparison

Outcomes
Primary outcome [1] 293548 0
Diathermy artefact

Defined as the outer zone of the specimen in contact with the diathermy loop where the thermal artefact makes the margin of the specimen uninterpretable.

A small ruler, called a micrometer, can be seen when viewing a specimen under a microscope. The pathologist will measure the distance from the outer zone of the specimen in contact with the diathermy loop to the zone where no tissue damage has occurred.
Timepoint [1] 293548 0
Measured after the cervical specimen has been processed by pathology. Usually a couple of days
Secondary outcome [1] 311342 0
Specimen fragmentation

Defined as more than one piece of cervical tissue removed with the LLETZ loop. If the cervical sample is removed in one piece there is no fragmentation.

Timepoint [1] 311342 0
At time of surgery
Secondary outcome [2] 311343 0
Haemorrhage
Timepoint [2] 311343 0
At time of surgery

Eligibility
Key inclusion criteria
>18yrs of age
High grade intraepithelial lesion of the cervix (HSIL) or persistent low grade intraepithelial lesion of the cervix (LSIL)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous cervical procedures including LLETZ or cone biopsy
Pregnancy

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)
Patients will be randomly assigned to either low or high power diathermy settings. The surgeon and pathologist will be unaware to which group they will be allocated.

Randomisation will be conducted using sequentially numbered opaque sealed envelopes which will be opened on the day of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of sealed opaque envelopes. Once the envelopes are created for each group they will be combined and shuffled.

Each envelope will then be number from one to forty. The envelopes will be selected in order as each patient has their surgery.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Using data from Nagar a standard deviation of 0.07mm was calculated for diathermy artefact. Sample size was calculated using a power level of 80% to detect a difference of 0.1mm with a p value <0.05

Nagar H, Dobbs S, McClelland H, Price J, McClean G, McCluggage W. The large loop excision of the transformation zone cut or blend thermal artefact study: a randomized controlled trial Int J Cynecol Cancer 2004, 14, 1108-1111

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3132 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 8884 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 290217 0
Hospital
Name [1] 290217 0
John Hunter Hospital
Address [1] 290217 0
Lookout Road
New Lambton Heights NSW 2305
Country [1] 290217 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 288928 0
None
Name [1] 288928 0
Address [1] 288928 0
Country [1] 288928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291923 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291923 0
Research Ethics and Governance Unit
District Headquarters, Administration Building
Lookout Road,
New Lambton NSW 2305
Ethics committee country [1] 291923 0
Australia
Date submitted for ethics approval [1] 291923 0
Approval date [1] 291923 0
05/11/2014
Ethics approval number [1] 291923 0
HNE HREC 14/10/15/3.03 ; NSW HREC HREC/14/HNE/386

Summary
Brief summary
This study will evaluate the way we treat pre-cancerous lesions on the cervix. These lesions are commonly removed using a wire loop termed large loop excision of the transformation zone (LLETZ).

The objective of this study is to compare different settings on the machine used to perform a LLETZ and compare the quality of the tissue obtained. All samples of tissue obtained from a LLETZ have a degree of tissue damage to the outer part of the tissue sample caused by the heat of the wire loop. This tissue damage is dependent on the settings used to obtain a LLETZ.

Currently there are a wide range of different settings used to perform a LLETZ procedure. We wish to compare two settings, low vs high power, which are already used by surgeons in the hospital to see which setting gives the best quality sample of tissue. High quality samples help determine if all of the abnormal tissue was removed from the cervix.

Each patient will have the procedure performed by the same surgeon who is a specialist in women’s cancers. The surgeon will not know which group the patient is allocated to, which is called blinding, to help improve the accuracy of the results. The doctor who will look at the tissue samples under the microscope, called a pathologist, will also be blinded.

We will then measure how much tissue damage occurs between the two groups using a small ruler in a microscope.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52462 0
Dr Malcolm Godfrey
Address 52462 0
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 52462 0
Australia
Phone 52462 0
+61 2 4921 3000
Fax 52462 0
Email 52462 0
malcolm.godfrey@hnehealth.nsw.gov.au
Contact person for public queries
Name 52463 0
Dr Malcolm Godfrey
Address 52463 0
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 52463 0
Australia
Phone 52463 0
+61 2 4921 3000
Fax 52463 0
Email 52463 0
malcolm.godfrey@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 52464 0
Dr Malcolm Godfrey
Address 52464 0
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 52464 0
Australia
Phone 52464 0
+61 2 4921 3000
Fax 52464 0
Email 52464 0
malcolm.godfrey@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary