Clinical trial · Interventional
Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
NCT01435590CI-TRIAL-00018059completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curette v/s endocervical brush | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Specimen adequacy
- timeFrame
- 09/2011 - 05/2012 (1 year)
- 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).
Secondary outcomes (1)
- measure
- Patient discomfort
- timeFrame
- 09/2011 to 05/2012 (8 months)
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDUndurraga 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. PMID 29107949