A pilot study comparing efficacy of a cervical intraepithelial neoplasia Excisor with loop electrosurgical excision procedure.

OBJECTIVE

To determine whether the proportion of incomplete resection of cervical intraepithelial neoplasia (CIN 1-3) may be reduced by CIN Excisor compared with loop excision of the transformation zone (LLETZ).

STUDY

DESIGN

A prospective trial during a 2-year period at a district general hospital in London, United Kingdom, including 420 women scheduled for treatment due to CIN, after colposcopy guided biopsy results. This study was expected to demonstrate a statistically significant difference (p<0.05) in the proportion of women with clear histopathological resection margins after treatment with CIN Excisor compared with LLETZ. Chi-square or Fisher's exact test were used to compare histopathological resection margins in the CIN Excisor and LLETZ groups.

RESULTS

Overall, there is strong evidence of a difference in the proportion of histopathological specimens with clear resection margins for the CIN Excisor group, compared with the LLETZ group (201/210, 95.7% versus 180/210, 85.7%: p<0.001). Sub-analysis within the two groups, of the proportion of histopathological specimens with clear resection margins in relation to CIN grades, revealed a statistically significant difference in favour of the CIN Excisor group for CIN 1 (99/103, 96.1% versus 82/95, 86.3%: p=0.01), and CIN 2 (73/77, 94.8% versus 68/80, 85%: p=0.04). There is a numerical difference in the proportion of clear resection margins in favour of the CIN Excisor for CIN 3 (29/30, 96.7% versus 30/35, 85.7%), but this difference was not statistically significant (p=0.21). Perioperative complications were similar between the two groups.

CONCLUSION

CIN Excisor achieved better results than LLETZ for treatment of CIN 1-3 with respect to clear histopathological resection margins. However, further studies including a larger number of women treated for CIN 3 are needed before firm conclusions are drawn.