Patient characteristics
CIN1/2 lesions, CIN, anxiety
CIN
From 06/2018 to 01/2020, we assessed 110 participants for study eligibility. HSI was prospectively applied in 41 patients with histologically proven CIN 1–3 in a controlled clinical trial (DRKS00013486) at the Department of Women’s Health, Tübingen, Germany. CIN was histologically diagnosed by colposcopy-directed biopsy prior to study enrollment. The present prospective, monocentric study included 41 patients aged between 28 and 71 years with histologically confirmed CIN (Patient’s characteristicsThe key inclusion criteria for study participation were ≥ 18 years of age, histologically confirmed CIN1-3 with indication for LEETZ, and ectocervical visibility of the lesion margin. Indication for LEETZ was only given in case of either CIN3 lesions, persisting CIN1/2 lesions over 24 months, or by the patient’s compelling wish for therapy (urgent desire to conceive, severe anxiety, and/or significant psychological stress). Prior to HIS measurement, the patients provided written informed consent in accordance with the approved ethical protocol (650-2017BO1) and were informed about the experimental nature of the measurement. CIN1–3 lesions were applied to HSI at native state after disinfection, lateral fixation by sutures, and manual externalization. After contact- and marker-independent HSI measurements, the individual CIN lesions were visualized using colposcopy and VIA, and photodocumented. After performing LEETZ under colposcopic guidance and mapping of CIN localization, the lesion again was histologically confirmed in the conisate. Primary end point was the accuracy of CIN detection and differentiation compared to intraindividual benign regions of the portio according to histological assessment. Figure Schematic of the intraoperative setup and experimental workflow. The portio uteri is externalized by lateral sutures. HSI is applied contact and marker independent on native state portio. VIA visualizes the location of the lesion for photodocumentation. CIN lesions are histologically confirmed after LEETZ