Clinical trial NCT01929993: A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Official title: Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Conization
Cervical Intraepithelial Neoplasia
Cervix Dysplasia
Therapy
Electrosurgery
Lead sponsor: Oswaldo Cruz Foundation
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 164
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.
timeFrame: one month after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Fernandes Figueira Institute - Oswaldo Cruz Foundation
state: RJ
Study officials:
affiliation: Oswaldo Cruz Foundation
name: Maria J Camargo, PHD
role: STUDY_DIRECTOR
References:
citation: 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.