Improving the quality of cervical screening.

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.

Needle versus loop diathermy excision of the transformation zone for the treatment of cervical intraepithelial neoplasia: a randomised controlled trial.

OBJECTIVE: To determine whether lower rates or incomplete resection of cervical intraepithelial neoplasia (CIN) may be achieved by needle excision of the transformation zone (NETZ) than with loop excision (LLETZ). DESIGN: A prospective randomised controlled trial. SETTING: A gynaecological oncology centre and a teaching hospital in West London. POPULATION: Four hundred and four women due to receive treatment for suspected CIN. METHODS: Women were randomised to receive either LLETZ or NETZ. MAIN OUTCOME MEASURES: The study was designed to demostrate a difference in the proportion of women with clear histological margins of 82% for LLETZ compared to 94% for NETZ with 90% power at a 5% significance level, allowing for absence of CIN in the treatment specimen in 15%. RESULTS: Four randomised women were excluded from the analysis, as they were ineligible for the study. Three hundred and forty-seven (87%) had CIN in the treatment specimen and could be included in the analysis of excision margins. More women in the NETZ arm had clear histological margins (84.8%vs 75%, (P= 0.03). The median volume of specimens in the NETZ arm was 739 mm(3) larger (P= 0.33) and they were less likely to be removed in multiple pieces (2.5%vs 29.5%, RR 0.09, 95% CI 0.04 to 0.20). Needle excision took longer to perform (median treatment time 210 vs 90 seconds, P<0.0001) and surgeons more often reported the procedure as 'difficult' (9.5%vs 3.0%, RR = 3.17%, 95% CI 1.33 to 7.58). No difference in peri-operative or post-operative complication rates could be demonstrated between the two groups. CONCLUSION: NETZ is more likely to produce a specimen in one piece and with clear margins compared to LLETZ.