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

Sponsor
University Hospital, Geneva (Other)
Overall Status
Completed
CT.gov ID
NCT01435590
Collaborator
(none)
180
Enrollment
36
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Curette v/s endocervical brush
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Manuela Undurraga Malinverno, Medecin Interne, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01435590
Other Study ID Numbers:
  • CER 11-029
First Posted:
Sep 16, 2011
Last Update Posted:
May 28, 2015
Last Verified:
May 1, 2015
Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of May 28, 2015