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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.
Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.
The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| excision of the lesion | Active Comparator |
| |
| espontaneous regression | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excision of the lesion | Procedure | Surgery with Large Loop Excision of Transformation Zone (LLETZ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9% | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia F Brenna, MD, PhD | Universidade Cidade de Sao Paulo | Principal Investigator |
| Ana C Guedes, MD, PhD | Universidade Cidade de Sao Paulo | Principal Investigator |
| Kari J Sirjanen, MD, PhD | University of Turku | Study Chair |
| Luis C Zeferino, MD, PhD | University of Campinas, Brazil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leonor Mendes de Barros Maternity Hospital | São Paulo | São Paulo | 03015000 | Brazil |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| Follow-up for spontaneous regression of the lesion | Other | Follow-up at last 12 months |
|
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |