None listed
Conditions
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 will be performed by the same surgeon who is a specialist in women's cancers. The whole procedure takes only a few minutes.
Sponsors
Study design
Eligibility
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