Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear

Study Overview
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Brief Summary
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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.

Official Title
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Endocervical Curettage Performed With a Kevorkian Curette Versus Cytobrush in Patients With ASC-H, LSIL, ASCUS HPV Positive and Non-contributory Colposcopy (ZT3) Smear or Atypical Pap Smear With Positive HPV Test

Conditions
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Cervical Cancer, Pathological Screening Smear

Intervention / Treatment
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* Device: Cytobrush
* Device: Kevorkian curette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kevorkian curette<br> | Device: Kevorkian curette<br>* the colposcopist holds the curette horizontally and scrapes the endocervical canal all the way around. He realizes 1 small firm and linear movement by quarter turn or 4 movements to realize a complete turn. During this act, the curette must remain inside the canal, and during its extraction, care should be taken not to rotate it so as not to spill the collected tissue contained in the basket of the curette. The tissue material thus obtained must be rapidly immersed in formalin<br>|
| Experimental: Cytobrush<br> | Device: Cytobrush<br>* the brush would be inserted in full until the display of the brush in the endocervical canal disappears. A neck quadrant scan (= quarter turn) will be performed from front to back while simultaneously rotating the brush clockwise, for a total of 3 laps. This would represent 4 sweeps per turn, ie 12 sweeps in total<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of sampling failures | Unsatisfactory sampling will be defined by a specimen containing <20 endocervical cells, <3 epithelial flaps, and one specimen without stroma. | once time, Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment Using a Visual Analogue Scale (VAS) |  | once time, Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endocervical curettage, Kevorkian, Cytobrush, FCV