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

Primary Purpose

Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Curette v/s endocervical brush
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Dysplasia

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    September 13, 2011
    Last Updated
    May 27, 2015
    Sponsor
    University Hospital, Geneva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01435590
    Brief Title
    Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Geneva

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Dysplasia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Curette v/s endocervical brush
    Primary Outcome Measure Information:
    Title
    Specimen adequacy
    Description
    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 Outcome Measure Information:
    Title
    Patient discomfort
    Description
    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)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29107949
    Citation
    Undurraga M, Catarino R, Navarria I, Ibrahim Y, Puget E, Royannez Drevard I, Pache JC, Tille JC, Petignat P. User perception of endocervical sampling: A randomized comparison of endocervical evaluation with the curette vs cytobrush. PLoS One. 2017 Nov 6;12(11):e0186812. doi: 10.1371/journal.pone.0186812. eCollection 2017.
    Results Reference
    derived

    Learn more about this trial

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

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