Background: Visual and acoustic virtual reality (VR) has been increasingly explored as a non-pharmacological tool for pain relief in clinical settings.Objective: We aimed to evaluate the effectiveness of VR as a distraction technique in the management of acute pain during operative hysteroscopy in the outpatient setting. Methods:A prospective, open-label, randomized control trial in a tertiary university-affiliated medical centre between April and August 2020. Overall, 82 women were randomly allocated to undergo operative hysteroscopy either with the use of VR (n = 44, study group) or with standard treatment (control group, n = 38). VR was applied throughout the procedure and no anaesthesia was given. The primary outcome measures included self-reported intraoperative pain. Other objectives included vital parameters as pulse rate (PR) and respiratory rate (RR) before and during the first 3 min of the procedure. Pain and anxiety outcomes were measured as numeric rating scores. Results:The baseline parameters were similar between groups. The mean duration for the procedure was 8.1 ± 3.2 vs. 7.3 ± 6.0 min for the study and the control groups (p = 0.23). There were no statistically significant differences between the reported pain scores during the procedure [median (interquartile range) 5.0 (3.0-7.2) vs. 5.0 (3.0-8.0), respectively; p = 0.67]. While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs. 14.0 (11.0-16.5); p = 0.77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); p = 0.01]. Conclusion:VR was not effective in reducing pain during an outpatient operative hysteroscopy.Significance: The use of a Virtual reality system was found ineffective in reducing pain during and after an office operative hysteroscopy without anaesthesia, in a thorough examination of both continuous physiological parameters and women's self-reported measures.This accompanies the following article: Dualé, C & Mourgues, C. The price of pain relief, or should non-invasive medical devices be treated differently in analgesic clinical trials?.

Background: Intrahepatic cholangiocarcinoma (iCCA) is a biliary tract malignancy with rising incidence in recent decades. While the causative role of cirrhosis in the development of iCCA is well established, the role of cirrhosis as a prognostic factor in iCCA is debatable. Materials and Methods: The study population consisted of 512 patients diagnosed with iCCA between 2004-2016 collected from the Surveillance, Epidemiology and End Results (SEER) database. The impact of fibrosis on overall and cancer-specific survival 12, 36 and 60 months following diagnosis, was evaluated in the entire cohort and in subgroups stratified according to treatment approach and the American Joint Committee on Cancer (AJCC) tumor stage using a Cox proportional-hazards model. Results: After adjusting for age, sex, race, year of diagnosis, AJCC stage, and surgical treatment strategy, advanced fibrosis was associated with worse cancerspecific survival across follow up periods (HR 1.49 (1.13-1.96, p = 0.005); HR 1.44 (1.14-1.83, p = 0.002) and HR 1.45 (1.15-1.83, p = 0.002) for 12, 36 and 60 months, respectively). Similar effects were observed for overall survival. Among patients that underwent surgical resection, advanced fibrosis was associated with worse overall survival and cancer-specific survival across follow up periods. Fibrosis was associated with worse overall and cancer-specific survival in patients with a later stage (III-IV) at diagnosis but this effect was not demonstrated in early stages. Conclusions: Patients with iCCA and advanced liver fibrosis have an increased risk of both overall and cancer-specific mortality compared to patients with earlier stages of fibrosis.

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