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

Not Applicable

Completed

• Conditions: Cervical Dysplasia

• Registration Number: NCT01435590
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Specimen adequacy	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).

Secondary Outcome Measures

Name	Time	Method
Patient discomfort	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).