Diagnostic accuracy of hand-held colposcope (Gynocular) in comparison with standard colposcope in patients with abnormal cervical cytology or visual inspection with acetic acid positivity: a cross over randomized controlled study.

Abstract

To compare the diagnostic accuracy of a handheld colposcope (Gynocular) versus a standard colposcope in women with abnormal cervical cytology or visual Inspection with acetic acid positivity. This crossover randomized clinical trial was conducted in Pondicherry, India, and included 230 women who were referred for colposcopy. Swede scores were calculated using both colposcopes, and a cervical biopsy was performed from the most visually abnormal areas. Swede scores were compared with the histopathological diagnosis, which was used as the reference standard. The level of agreement between the two colposcopes was calculated using Kappa (κ) statistics. The level of agreement of Swede scores between the standard and Gynocular colposcopes was 62.56%, and the κ statistic was 0.43 (P<0.001). Cervical intraepithelial neoplasia (CIN) 2+ (CIN 2, CIN 3, CIN 3+) was diagnosed in 40 (17.4%) women. There were no significant differences between the two colposcopes in terms of sensitivity, specificity, or predictive value for detecting CIN 2+ lesions. The diagnostic accuracy of Gynocular colposcopy was similar to that of standard colposcopy for detecting CIN 2+ lesions. Gynocular colposcopes showed a good level of agreement with standard colposcopes when the Swede score was used.