Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins
Verified date | June 2015 |
Source | Oswaldo Cruz Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 164 |
Est. completion date | February 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Fernandes Figueira Institute - Oswaldo Cruz Foundation | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Oswaldo Cruz Foundation |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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