A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins

The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in reducing the incomplete excision of disease.

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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

Fernandes Figueira Institute - Oswaldo Cruz Foundation

Rio de Janeiro, 22250-020, Brazil

About this study

Cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. Although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. Also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease.

The standard procedure, Large Loop Excision of the Transformation Zone (LLETZ-cone), is performed with a large loop electrode of 20-25 mm depth.

The experimental intervention is Straight Wire Excision of the Transformation Zone (SWETZ), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease.

Both procedures were previously studied in another clinical trial(NCT00995020), but the histological analysis were inconclusive for many outcomes. SWETZ were superior to LLETZ cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size.

This study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients were eligible if the colposcopist decided that a cone biopsy was indicated.
Common indications for a cone biopsy included:

High-grade Squamous Intraepithelial Lesion in a type 3 transformation zone,
suspicion of micro-invasive or invasive carcinoma and
suspicion of glandular disease.

Exclusion criteria

Patients were excluded if pregnancy, coagulation disorders and cervicitis were present or if they refused to participate in the study.

Treatment and study plan

SWETZ

Procedure

Straight wire excision of transformation zone is an 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

LLETZ cone

Procedure

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

Other names: LEEP - Loop electrosurgical excision procedure.

Primary outcomes

The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.

Time frame: one month after the procedure

Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.

Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Registry information

Official study title

Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Aug 28, 2013
Registry last updated: Jul 23, 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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Completed