Obstet Gynecol Sci.  2023 Jul;66(4):300-306. 10.5468/ogs.23089.

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

• Jayabalan S
• Subbaiah M
• Chaturvedula L

• KMID: 2544385
• DOI: http://doi.org/10.5468/ogs.23089

Abstract

Objective
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.
Methods
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.
Results
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.
Conclusion
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.

Keyword

Cervical intraepithelial neoplasia; Colposcopy; Gynocular; Swede score; VIA

Figure

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  Fig. 1 Consort flow diagram.

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  Fig. 2 Receiver operating characteristic curves comparing both colposcopes in identifying women with CIN 2+ lesions. CIN, cervical intraepithelial neoplasia.

Reference

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