Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to diagnostic and patient discomfort.
METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC) or and endocervical brush. All samples will be submitted for histological study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
- Specimen adequacy [ Time Frame: 09/2011 - 05/2012 (1 year) ] [ Designated as safety issue: No ]Cytological and histological interpretation of the endocervical brush specimens will then be performed, while for the endocervical currete specimens only histological interpretation will be done. The adequacy of the specimens will be based on the quantity of endocervical cells present (< or ≥ 20 endocervical cells), the quantity of histological material (< or ≥ 3 epithelial stripes) and the quality of histological material (absence or presence of lamina propia).
- Patient discomfort [ Time Frame: 09/2011 to 05/2012 (8 months) ] [ Designated as safety issue: No ]To evaluate the degree of patient discomfort, patients will be requested to complete a questionnaire once the exam has been completed. The main acceptance variables will be degree of helplessness, pain (on visual analog scales), willingness to undergo the test again, and overall satisfaction. Once the exam has been completed, the doctor performing the sampling will answer a questionnaire indicating his/her perception of the exam (patient's pain, technical difficulty performing the exam, doctors acceptability of the exam).
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|