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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01435590

Enrollment

180

Registered

2011-09-16

Start date

2011-09-30

Completion date

2014-09-30

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dysplasia

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.

Interventions

PROCEDURECurette v/s endocervical brush

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026