This is the first Enhanced Recovery After Surgery (ERAS) guideline dedicated to standardizing and optimizing perioperative care for women undergoing minimally invasive gynecologic surgery. The guideline was rigorously formulated by an American Association of Gynecologic Laparoscopists Task Force of US and Canadian gynecologic surgeons with special interest and experience in adapting ERAS practices for patients requiring minimally invasive gynecologic surgery. It builds on the 2016 ERAS Society recommendations for perioperative care in gynecologic/oncologic surgery by serving as a more comprehensive reference for minimally invasive endoscopic and vaginal surgery for both benign and malignant gynecologic conditions. For example, the section on preoperative optimization provides more specific recommendations derived from the ambulatory surgery and anesthesia literature for the management of anemia, hyperglycemia, and obstructive sleep apnea. Recommendations pertaining to multimodal analgesia account for the recent Food and Drug Administration warnings about respiratory depression from gabapentinoids. The guideline focuses on workflows important to high-value care in minimally invasive surgery, such as same-day discharge, and tackles controversial issues in minimally invasive surgery, such as thromboprophylaxis. In these ways, the guideline supports the American Association of Gynecologic Laparoscopists and our collective mission to elevate the quality and safety of healthcare for women through excellence in clinical practice.
Vulvar lichen sclerosus (LS) is a dermatologic condition characterized by labial atrophy, hypopigmentation, and synechiae leading to pruritis and vulvar pain. Lichen sclerosus also is associated with a 3% to 9% incidence of vulvar squamous cell carcinoma that may be mitigated by adequate treatment. Inconsistent prescribing and patient intolerance have reduced the proportion of LS patients receiving criterion standard treatment with clobetasol propionate, a potent topical steroid with a reported range of efficacy between 66% and 96% and rate of complete remission between 23% and 54%. In case series, additional treatment with vulvovaginal fractionated carbon dioxide (CO 2 ) laser has improved 80% to 88% of refractory LS patients.This single-center randomized controlled trial aimed to compare fractionated CO 2 laser treatment with clobetasol propionate in terms of safety and efficacy for the treatment of vulvar LS. Postmenopausal, English-speaking women with pathologically confirmed LS were recruited from urogynecologic and gynecology academic medical center office visits. Eligible participants had LS symptoms corresponding to a score of 21 or higher on the Skindex-29 dermatologic symptom scoring system, indicating at least mild bother. Patients who had received prior LS treatments were not excluded. Participants underwent block randomization in a 1:1 ratio to either the topical clobetasol ointment arm or the laser arm. Participants in the clobetasol arm applied 0.05% ointment to the affected area nightly for 1 month, 3 times weekly for 2 months, then as needed. Participants in the laser arm underwent 3 office laser treatments 4 to 6 weeks apart. Data collection occurred at baseline, 6 months, and 12 months with multiple validated scales, surveys, and photo documentation. The primary outcome was change in mean Skindex-29 score at 6 months.Between October 2015 and July 2018, a total of 52 participants were enrolled in this study. A total of 27 women completed laser treatment and 6-month follow-up, whereas 24 completed clobetasol treatment and 6-month follow-up, with 1 dropout. No significant differences in socioeconomic factors, length of diagnosis, Skindex-29 scores, or treatment history existed between the 2 groups. Intention-to-treat analysis found greater improvement in Skindex-29 score among the laser group compared with the steroid group (laser −16.83 ± 18.09 vs steroid −5.92 ± 5.81; P = 0.007). Secondary outcomes including Skindex-29 subscale scores for emotion (laser −19.63 ± 21.92 vs steroid −6.77 ± 9.99; P = 0.011) and symptoms (laser −21.93 ± 22.18 vs steroid −4.91 ± 11.19; P = 0.002) showed a similar trend. When stratifying for previous clobetasol propionate treatment, the improvement in Skindex-29 overall score was only seen in the previously exposed group. The clobetasol propionate-naive group in general had less improvement than the previous use group. Secondary outcomes of physician assessment scores found a significant improvement in mean change of Vaginal Health Index scores between baseline and 6 m...
There was no difference in mesh-related complications between groups (1.6% TVH-LSC vs 1.7% LSH-LSC; P = 1.0). Vaginal mesh attachment during TVH-LSC decreased operative time by over 1 hour with no differences in intraoperative complications, reoperation for recurrent prolapse, and subjective or objective outcomes compared to LSH-LSC.
Introduction
Vape shops represent prominent, unique retailers, subject to Food and Drug Administration (FDA) regulation in the United States.
Aims and Methods
This study assessed compliance of US vape shop retail marketing strategies with new regulations (eg, required age verification, prohibited free samples) and pre-implementation conditions for other regulations (eg, health warning labels on all nicotine products, required disclosures of e-liquid contents).
Results
95.0% of shops displayed minimum-age signage; however, mystery shoppers were asked for age verification at 35.6% upon entry and at 23.4% upon purchase. Although 85.5% of shops had some evidence of implementing FDA health warnings, 29.1% had signage indicating prohibited health claims, 16.3% offered free e-liquid samples, 27.4% had signage with cartoon imagery, and 33.3% were within two blocks of schools. All shops sold open-system devices, 64.8% sold closed-system devices, 68.2% sold their own brand of e-liquids, 42.5% sold e-liquids containing cannabidiol, 83.2% offered price promotions of some kind, and 89.9% had signage for product and price promotions.
Conclusions
Results indicated that most shops complied with some implementation of FDA health warnings and with free sampling bans and minimum-age signage. Other findings indicated concerns related to underage access, health claims, promotional strategies, and cannabidiol product offerings, which call for further FDA and state regulatory/enforcement efforts.
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