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Diathermy artefact in LLETZ specimens: A randomised controlled trial of high versus low power pure cut diathermy

Diathermy artefact in LLETZ specimens: A randomised controlled trial of high versus low power pure cut diathermy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000035527
Enrollment
62
Registered
2015-01-19
Start date
2015-05-06
Completion date
2016-08-12
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 wil

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.

Sponsors

John Hunter Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

>18yrs of age High grade intraepithelial lesion of the cervix (HSIL) or persistent low grade intraepithelial lesion of the cervix (LSIL)

Exclusion criteria

Previous cervical procedures including LLETZ or cone biopsy Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026