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

NCT01929993 | Completed Phase 3 Results

• 1 other identifier: 522/12
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Conization; Cervical Intraepithelial Neoplasia; Cervix Dysplasia; Therapy; Electrosurgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SWETZ

EXPERIMENTAL

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

Procedure: SWETZ

LLETZ cone

ACTIVE COMPARATOR

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

Procedure: LLETZ cone

Interventions

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.

Also known as: NETZ - Needle excision of transformation zone

SWETZ

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.

Also known as: LEEP - Loop electrosurgical excision procedure.

LLETZ cone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (1)

Fernandes Figueira Institute - Oswaldo Cruz Foundation

Rio de Janeiro, Rio de Janeiro, 22250-020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25783647 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Hyperthermia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Fábio Russomano
• Organization: Fundação Oswaldo Cruz

fabiorussomano@gmail.com

55 21 25541815

Study Officials

• Maria J Camargo, PHD

  Oswaldo Cruz Foundation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: June 10, 2012
• First Posted: August 28, 2013
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 23, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-06

Locations

BR (1)