Brief Title
Recurrence in High-grade Lesions After Conization
Official Title
Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone
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.
Study Type
Observational
Primary Outcome
Recurrence rates after conization
Condition
Cervical Intraepithelial Neoplasia
Study Arms / Comparison Groups
Case
Description: Recurrent lesions
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
103
Start Date
January 2001
Completion Date
December 2007
Primary Completion Date
January 2007
Eligibility Criteria
Inclusion Criteria:
1. history of surgery for conization
Exclusion Criteria:
1. under 18 years of age,
2. immunosuppressed,
3. Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
4. Patient with invasion, or surgical margins obtained by LLETZ that were unable to be
evaluated.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
EMERSON OLIVEIRA, PhD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02540421
Organization ID
CIN1701
Responsible Party
Principal Investigator
Study Sponsor
Faculdade de Medicina do ABC
Study Sponsor
EMERSON OLIVEIRA, PhD, Principal Investigator, FACULTY OF MEDICINE OF ABC
Verification Date
September 2015