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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435590
First Posted: September 16, 2011
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manuela Undurraga Malinverno, University Hospital, Geneva
  Purpose

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.


Condition Intervention
Cervical Dysplasia Procedure: Curette v/s endocervical brush

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Manuela Undurraga Malinverno, University Hospital, Geneva:

Primary Outcome Measures:
  • Specimen adequacy [ Time Frame: 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:
  • Patient discomfort [ Time Frame: 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).


Estimated Enrollment: 180
Study Start Date: September 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Manuela Undurraga Malinverno, Medecin Interne, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01435590     History of Changes
Other Study ID Numbers: CER 11-029
First Submitted: September 13, 2011
First Posted: September 16, 2011
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type