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

Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : 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.

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Procedure: SWETZ; Procedure: LLETZ cone

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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22250-020
      • Fernandes Figueira Institute - Oswaldo Cruz Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SWETZ; Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.	Procedure: 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.; Other Names: NETZ - Needle excision of transformation zone
Active Comparator: LLETZ cone; LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.	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.; Other Names: LEEP - Loop electrosurgical excision procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.	Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.	one month after the procedure

Collaborators and Investigators

• Sponsor: Oswaldo Cruz Foundation
• Investigators: Study Director: Maria J Camargo, PHD, Oswaldo Cruz Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 10, 2012
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Cervical Intraepithelial Neoplasia; Therapy; Electrosurgery; Conization; Cervix Dysplasia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Neoplasms; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: 522/12