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

Cervical Dysplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435590
• Other study ID #: CER 11-029
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: May 27, 2015
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Procedure:
• Curette v/s endocervical brush

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	09/2011 - 05/2012 (1 year)	No
Secondary	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).	09/2011 to 05/2012 (8 months)	No