Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear
Not Applicable
- Conditions
- Cervical CancerPathological Screening Smear
- Interventions
- Device: CytobrushDevice: Kevorkian curette
- Registration Number
- NCT04000477
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
The recommendations on the method and the realization of the cervico-uterine smears are clear. With regard to performing endocervical curettage, several methods are possible without precise consensus. In general, the Kevorkian curette is widely used. However, it is often reported by doctors and patients that curettage is painful. Some articles show that the cytobrush would be less painful. While keeping a percentage of correct curettage failures, it is sought to show that the cytobrush would improve the comfort of the patient during curettage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 588
Inclusion Criteria
- Women followed for a cervical pathology requiring endocervical curettage:
- AGC type (glandular cell atypia) with positive HPV test
- Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3)
Exclusion Criteria
- Pregnant woman
- Women under the age of 25 or over 65
- Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material)
- Presence of a vaginal lesion on colposcopic examination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cytobrush Cytobrush - Kevorkian curette Kevorkian curette -
- Primary Outcome Measures
Name Time Method Percentage of sampling failures once time, Baseline Unsatisfactory sampling will be defined by a specimen containing \<20 endocervical cells, \<3 epithelial flaps, and one specimen without stroma.
- Secondary Outcome Measures
Name Time Method Pain Assessment Using a Visual Analogue Scale (VAS) once time, Baseline