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

Sanu, Olaleye; Pal, Alak; George, Samuel

doi:10.1016/j.ejogrb.2010.02.042

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Volume 151, Issue 1 , Pages 91-95, July 2010

A pilot study comparing efficacy of a cervical intraepithelial neoplasia excisor with loop electrosurgical excision procedure☆

Received 17 October 2009; received in revised form 18 January 2010; accepted 21 February 2010. published online 08 March 2010.

Abstract

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.

Keyword: Pilot trial of CIN Excisor