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

NCT ID: NCT01929993

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-02-29

Brief Summary

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.

Detailed Description

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.

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SWETZ

Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.

Group Type: EXPERIMENTAL

SWETZ

Intervention Type: 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.

LLETZ cone

LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.

Group Type: ACTIVE_COMPARATOR

LLETZ cone

Intervention Type: 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.

Interventions

SWETZ

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.

Intervention Type: PROCEDURE

LLETZ cone

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.

Intervention Type: PROCEDURE

Other Intervention Names

NETZ - Needle excision of transformation zone; LEEP - Loop electrosurgical excision procedure.

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oswaldo Cruz Foundation

OTHER

Sponsor Role: lead

Responsible Party

MJCamargo

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria J Camargo, PHD

Role: STUDY_DIRECTOR

Oswaldo Cruz Foundation

Locations

Fernandes Figueira Institute - Oswaldo Cruz Foundation

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Russomano F, Tristao MA, Cortes R, de Camargo MJ. A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study. BMC Womens Health. 2015;15:12. doi: 10.1186/s12905-015-0174-5. Epub 2015 Feb 18.

Reference Type: DERIVED

PMID: 25783647 (View on PubMed)

Other Identifiers

522/12

Identifier Type: -

Identifier Source: org_study_id