OBJECTIVE: To compare the adequacy of cervical cytology sampling by a newly designed cervical cell sampler (the implement) with a commonly used, extended tip cervical scraper, namely the Jordan's spatula, by assessing the quality of cervical smears obtained. DESIGN: Prospective randomised controlled trial, with the approval of the local Ethics Committee after informing the Medical Devices Agency in the UK. SETTING:Colposcopy Clinic in a District General NHS Trust Hospital in London. POPULATION: Women attending the Colposcopy Clinic and having a good command of the English language (to avoid any misinterpretation of the information and enabling them to give informed consent) were invited to take part. Two hundred and twenty patients were recruited. METHODS: The women were randomised into two groups, each of them having two smears at the same time, half of them having their first smear with the Jordan's spatula and the other half having the first smear with the new implement. MAIN OUTCOME MEASURE: Good quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. RESULTS: Fifty-four percent of smears taken by the new implement showed good quality smears, compared with 37% taken by Jordan's spatula, a statistically significant result with P value <0.001. CONCLUSION: A larger number of good quality smears, judged by evidence of sampling of transformation zone and presence of endocervical cells, were obtained with the new implement. The difference was statistically significant. This would enhance the ability to detect dyskaryosis and increase adequate smear rates, reducing unnecessary recall of patients for repeat smears.
RCT Entities:
OBJECTIVE: To compare the adequacy of cervical cytology sampling by a newly designed cervical cell sampler (the implement) with a commonly used, extended tip cervical scraper, namely the Jordan's spatula, by assessing the quality of cervical smears obtained. DESIGN: Prospective randomised controlled trial, with the approval of the local Ethics Committee after informing the Medical Devices Agency in the UK. SETTING: Colposcopy Clinic in a District General NHS Trust Hospital in London. POPULATION: Women attending the Colposcopy Clinic and having a good command of the English language (to avoid any misinterpretation of the information and enabling them to give informed consent) were invited to take part. Two hundred and twenty patients were recruited. METHODS: The women were randomised into two groups, each of them having two smears at the same time, half of them having their first smear with the Jordan's spatula and the other half having the first smear with the new implement. MAIN OUTCOME MEASURE: Good quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. RESULTS: Fifty-four percent of smears taken by the new implement showed good quality smears, compared with 37% taken by Jordan's spatula, a statistically significant result with P value <0.001. CONCLUSION: A larger number of good quality smears, judged by evidence of sampling of transformation zone and presence of endocervical cells, were obtained with the new implement. The difference was statistically significant. This would enhance the ability to detect dyskaryosis and increase adequate smear rates, reducing unnecessary recall of patients for repeat smears.