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Completed

NCT Number: NCT00995020

Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion

The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.

SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heat Stress Disorders Hyperthermia Neoplasms Pathological Conditions, Signs and Symptoms Precancerous Conditions Signs and Symptoms Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Wounds and Injuries

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Fernandes Figueira, Rio de Janeiro, Brazil

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About this study

The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone . When the transformation zone contains squamous precancer and is completely ectocervical and therefore full visible, excision or destruction is an effective and relatively straightforward therapeutic entity. However in a small proportion of women a cone biopsy is necessary. A cone biopsy often requires the excision of 20-30 mms of endocervical canal.

Interventions.

  • The standard procedure, LLETZ - cone (Large Loop Excision of Transformation Zone cone biopsy), is performed with a large loop electrode of 20-25 mm depth. The activated loop was applied to the cervix outside the lateral margin of transformation zone and brought slowly to the controlateral margin with the objective to acquire 20-25 mm up the canal.
  • The experimental intervention is SWETZ (Straight Wire Excision of Transformation Zone), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. The activated wire was used as a knife, fashioning a cone with desired dimensions.

This technique may be able to excise the endocervical transformation zone with a lower rate of morbidity and incomplete excision rate than LLETZ cone biopsy.

The hypothesis to be tested in this trial is that SWETZ is superior to LLETZ cone in the management of endocervical pre-invasive disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Incompletely visible transformation zone in women with High grade Squamous Intraepithelial Lesion (HSIL)
  • Suspicion of microinvasive carcinoma or occult invasive carcinoma
  • Suspicion of glandular disease

Exclusion criteria

  • Pregnancy
  • Coagulation disorders
  • Cervicitis were present
  • Refusal to participate in the study

Treatment and study plan

Straight Wire Excision of Transformation Zone

Procedure

Straight wire excision of transformation zone is a electrosurgical conization method,which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.

Other names: NETZ - Needle Excision Of Transformation Zone

Large Loop Excision of Transformation Zone (cone biopsy)

Procedure

LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20-25 mm depth. The loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin.

Other names: LEEP - Loop Electrosurgical Procedure

Primary outcomes

  1. Endocervical Margin Not Free of Disease.

    Time frame: 3 months after the surgery is performed.

    Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.

Secondary outcomes

  1. Time Spent to Perform the Procedure

    Time frame: Time spent from randomization to complete the procedure

    Time was recorded from insertion until removal of the vaginal speculum.

Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Registry information

Official study title

A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.

Important dates

Study start
1999
Primary completion
2004
Study completion
2010
First posted
Oct 14, 2009
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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