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Evaluation of Stationary Colposcope and the Gynocular, by the Swede Score Systematic Colposcopic System in VIA Positive Women: A Crossover Randomized Trial
  1. Ashrafun Nessa, MRCOG, PhD*,
  2. Charlotte Wistrand, BSN,
  3. Shirin Akter Begum, MS*,
  4. Marcus Thuresson, PhD,
  5. Isaac Shemer, MD, PhD§,
  6. Malin Thorsell, MD, PhD and
  7. Elisabeth Andrea Wikström Shemer, MD, PhD
  1. *Department of Obstetrics and Gynecology, Bangabandhu Sheikh Mujib Medical University Hospital, Dhaka, Bangladesh;
  2. Department of Obstetrics and Gynecology, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden;
  3. Statisticon, Uppsala; and
  4. §Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
  1. Address correspondence and reprint requests to Elisabeth Andrea Wikström Shemer, MD, PhD, Department of Obstetrics and Gynecology, Department of Clinical Sciences, Danderyd Hospital, 181 82 Danderyd, Karolinska Institutet, Stockholm, Sweden. E-mail: elisabeth{at}gynocular.com.

Abstract

Objective This study aimed to evaluate cervical lesions by the Swede coloscopy system, histologic finding, liquid-based cytology, and human papillomavirus (HPV) in women who resulted positive for visual inspection of the cervix with acetic acid (VIA) by using a pocket-sized battery-driven colposcope, the Gynocular (Gynius AB, Sweden).

Methods This study was a crossover, randomized clinical trial at the colposcopy clinic of Bangabandhu Sheikh Mujib Medical University in Dhaka, Bangladesh, with 540 VIA-positive women. Swede scores were obtained by the Gynocular and stationary colposcope, as well as samples for liquid-based cytology, HPV, and cervical biopsies. The Swede scores were compared against the histologic diagnosis and used as criterion standard. The percentage agreement and the κ statistic for the Gynocular and standard colposcope were also calculated.

Results The Gynocular and stationary colposcope showed high agreement in Swede scores with a κ statistic of 0.998, P value of less than 0.0001, and no difference in detecting cervical lesions in biopsy. Biopsy detected cervical intraepithelial neoplasia (CIN) 2+ (CIN2, CIN3, and invasive cancer) in 38 (7%) of the women, whereas liquid-based cytology detected CIN2+ in 13 (2.5%) of the women. Forty-four (8.6%) women who were tested resulted positive for HPV; 20 (3.9%) women had HPV-16, 2 (0.4%) had HPV-18, and 22 (4.3%) had other high-risk HPV.

Conclusions Our study showed that few VIA-positive women had CIN2+ lesions or HPV infection. Colposcopy by Swede score identified significantly more CIN2+ lesions than liquid-based cytology and could offer a more accurate screening and selection for immediate treatment of cervical lesions in low-resource settings.

  • Cervical cancer
  • HPV
  • Cytology
  • Gynocular
  • Colposcope

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Footnotes

  • This study was supported by the H&M Conscious Foundation and the Gynius AB.

  • The authors declare no conflicts of interest.

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