Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix

University Hospital, Geneva180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

180

Conditions

Cervical Dysplasia

Interventions

Curette v/s endocervical brushPROCEDURE

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * French-speaking * 21 years or older * Attending our colposcopy clinic * Need for endocervical evaluation * Full autonomy or capacity to understand the procedures Exclusion Criteria: * Pregnancy * Absence of uterus * History of DES exposure in utero

Outcomes

Primary Outcomes

Specimen adequacy

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).

Time frame: 09/2011 - 05/2012 (1 year)

Secondary Outcomes

Patient discomfort

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).

Time frame: 09/2011 to 05/2012 (8 months)

Data from ClinicalTrials.gov

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