Recurrence in High-grade Lesions After Conization
- Conditions
- Cervical Intraepithelial Neoplasia
- Registration Number
- NCT02540421
- Lead Sponsor
- Faculdade de Medicina do ABC
- Brief Summary
Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).
Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
- history of surgery for conization
- under 18 years of age,
- immunosuppressed,
- Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
- Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence rates after conization 12 months Number of patients who are regarded as recurrence based on the following criteria:
- relapse occurred when cytology and/or biopsy showed that CIN had returned after 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Emerson de Oliveira
🇧🇷Santo Andre, SP, Brazil