Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
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|ClinicalTrials.gov Identifier: NCT01435590|
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Dysplasia||Procedure: Curette v/s endocervical brush||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
- Specimen adequacy [ Time Frame: 09/2011 - 05/2012 (1 year) ]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) ]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).