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Study Objective: This study aimed to determine the effect of the implementation of the Enhanced Recovery After Surgery (ERAS) protocol among patients receiving minimally invasive gynecologic surgery., Design and Setting: This retrospective cohort study was performed in a tertiary care hospital., Patients: A total of 328 females who underwent minimally invasive gynecologic surgeries requiring at least one overnight stay at Keck Hospital of University of Southern California (USC), California, USA, from 2016 to 2020 were included in this study., Interventions: The institutional ERAS protocol was implemented in late 2018. A total of 186 patients from 2016 to 2018 prior to the implementation were compared to 142 patients from 2018 to 2020 after the implementation. Intraoperatively, the ERAS group received a multimodal analgesic regimen (including bilateral quadratus lumborum (QL) blocks) and postoperative care geared toward a satisfactory, safe, and expeditious discharge., Measurements and Main Results: The two groups were similar in demographics, except for the shorter surgical time noted in the ERAS group. The median opioid use was significantly less among the ERAS patients compared with the non-ERAS patients on postoperative day 1 (7.5 vs. 14.3 mg; p<0.001) and throughout the hospital stay (17.4 vs. 36.2 mg; p<0.001). The ERAS group also had a shorter median hospital length of stay compared to the non-ERAS group (p<0.01). Among patients with a malignant diagnosis, patients in the ERAS group had significantly less postoperative day 1 and total opioid use and a shorter hospital stay (p<0.01). Within the ERAS group, 20% of the patients did not end up receiving a QL block. Opioid use and length of stay were similar between patients who did and did not receive the QL block., Conclusions: The ERAS pathway was associated with a reduction in opioid use postoperatively and a shorter length of hospital stay after minimally invasive gynecologic surgery. There was a more significant decrease in opioid use and hospital length of stay for patients with malignant diagnoses compared to patients with benign diagnoses. Further research can be done to fully delineate the effect of QL blocks in ERAS protocols., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Lee et al.)

Background: Adjuvant hysterectomy following chemoradiation for bulky, early stage cervical cancer has been shown to decrease local relapse rate. The objective of this study is to compare complications and recurrences between minimally invasive and open adjuvant hysterectomy for early stage cervical cancer., Methods: Patients were identified who had undergone adjuvant hysterectomy following chemoradiation for 2009 FIGO stage IB2 and IIA2 cervical cancer from August 2006 to June 2018. Demographic information, treatment course, complications, recurrence data were retrospectively extracted from the medical record. Frequency of complications was compared with Fisher exact test or chi-square test as appropriate and inverse probability of treatment propensity score weighting was used to calculate the disease-free survival., Results: Fifty-four patients met inclusion criteria with a median follow up time of 60.4 months (interquartile range 28.0-98.1 months). There were 24 (44%) open versus 30 (56%) minimally invasive hysterectomies performed. The overall grade 2 or worse complication rate was 43%. There were 8 (27%) patients with complications in the minimally invasive group compared to 4 (17%) in the open group (OR 1.82 (95% CI 0.5-7.0)). There were 9 vaginal cuff defects, dehiscences and/or fistulas in the minimally invasive group compared to 3 in the open group (OR 3.0 (95% CI 0.8-11.2)). There was no statistically significant difference between disease free survival and overall survival among the two groups, however there was a trend towards decreased disease-free survival in the minimally invasive group., Conclusions: Among women undergoing adjuvant hysterectomy following chemoradiation for bulky, early stage cervical cancer, there was no difference in complication rates between an open or minimally invasive surgical approach. However, the overall complication rate was high, including a high rate of vaginal cuff defect, dehiscence and/or fistulas. Our findings suggest that an adjuvant hysterectomy should be reserved for patients in which chemoradiation is not anticipated to successfully treat the primary tumor and, if performed, an open approach should be considered.

Unlabelled: To evaluate the activity of gemcitabine and docetaxel in patients with recurrent ovarian cancer., Methods: Patients with platinum-resistant disease and prior treatment with paclitaxel received treatment with docetaxel on day 1 and gemcitabine on days 1 and 8, repeated every three weeks., Results: Twenty patients, with a platinum-free interval of three months, were enrolled. Overall response rate was 25%. Treatment was associated with significant myelosuppression., Conclusions: In chemotherapy-resistant patients, this regimen exhibited encouraging activity. Excessive myelosuppression led to early closure. This was prevented by administering docetaxel on day 8 (instead of day 1) and prophylactic use of G-CSF.

Introduction: The objective is to develop a low-fidelity total abdominal hysterectomy (TAH) model for resident training with the purpose to improve residents' knowledge of anatomy, instruments, instrument handling, suture selection, and steps of a TAH., Methods: A TAH model was created using products purchased from a crafts store. Obstetrics and gynecology residents (second-year residents and fourth-year residents) were subjected to a lecture followed by a simulated TAH. Before and after the course, subjects were given a survey to assess their confidence regarding the different surgical aspects of the TAH. Confidence was assessed regarding knowledge of anatomy, instruments, instrument handling, suture selection, incision site, steps of the TAH, and global confidence. Statistical analysis was performed using nonparametric tests. A P < 0.05 was considered significant., Results: A low-fidelity TAH model was created. Eight second-year residents and seven fourth-year residents were studied. As expected, second-year residents had a lower median number of hysterectomies performed as primary surgeon when compared with fourth-year residents [0.5 (0.0-1.75) vs. 51.0 (50.0-53.0); P < 0.05]. Despite this difference, after having undergone the course, both resident classes demonstrated either statistical trends or significantly increased surgical confidence in all areas studied., Conclusion: Our novel, low-fidelity TAH simulation model and course improves obstetrics and gynecology residents' confidence in surgical skills and knowledge, particularly for those with less surgical experience. The total cost to make approximately 18 models was US $60.00.

Background: The authors implemented a controlled, randomized trial that compared 2 interventions: the provision of written resource navigation information (enhanced usual care [EUC]) versus written information plus patient navigation (TPN) aimed at improving adjuvant treatment adherence and follow-up among 487 low-income, predominantly Hispanic women with breast cancer or gynecologic cancer., Methods: Women were randomized to receive either TPN or EUC; and chemotherapy, radiation therapy, hormone therapy, and follow-up were assessed over 12 months. Patients with breast cancer were analyzed separately from patients with gynecologic cancer., Results: Overall adherence rates ranged from 87% to 94%, and there were no significant differences between the TPN group and the EUC group. Among women with breast cancer, 90% of the EUC group and 88% of the TPN group completed chemotherapy (14% of the EUC group and 26% of the TPN group delayed the completion of chemotherapy), 2% of the EUC group and 4% of the TPN group failed to complete chemotherapy, and 8% of the EUC group and 7% of the TPN group refused chemotherapy. Radiation treatment adherence was similar between the groups: Ninety percent of patients completed radiation (40% of the EUC group and 42% of the TPN group delayed the completion of radiation); in both groups, 2% failed to complete radiation, and 8% refused radiation. Among gynecologic patients, 87% of the EUC group and 94% of the TPN group completed chemotherapy (41% of the EUC group and 31% of the TPN group completed it with delays), 7% of the EUC group and 6% of the TPN group failed to complete chemotherapy, 6% of the EUC refused chemotherapy, 87% of the EUC group and 84% of the TPN group completed radiation (51% of the EUC group and 42% of the TPN with delays), 5% of the EUC group and 8% of the TPN group failed to complete radiation, and 8% of the EUC group and 5% of the TPN group refused radiation., Conclusions: Treatment adherence across randomized groups was notably higher than reported in previous studies, suggesting that active telephone patient navigation or written resource informational materials may facilitate adherence among low-income, predominantly Hispanic women. Adherence also may have be facilitated by federal-state breast and cervical cancer treatment funding., (2009 American Cancer Society.)

Study Objective: To assess whether volume of laparoscopic experience correlates with residents' performance on laparoscopic training drills., Design: Residents performed 4 laparoscopic drills in the inanimate laboratory: peg transfer, bean drop, rope pass, and triangle transfer. Performance times were recorded. Laparoscopic experience as primary surgeon was determined from resident case logs. The resident data were divided according to volume of laparoscopic experience (0-19, 20-39, > or =40 cases). Performance times were compared among the groups according to volume of laparoscopic surgical experience., Design Classification: II-3., Setting: This study was conducted in a university school of medicine surgical skills laboratory., Participants: Participants in this study were obstetrics and gynecology residents entering their second through fourth years of training., Interventions: Laparoscopic trainer drill performance times were recorded and correlated with amount of operative laparoscopic experience., Measurements and Main Results: In all, 25 residents participated. Only the peg transfer drill showed statistically significant correlation between faster performance time and increasing laparoscopic experience (p =.01). No significant association existed between laparoscopic experience and performance time on the bean drop, triangle transfer, or rope pass drills., Conclusion: Residents with more laparoscopic experience performed the peg transfer drill significantly faster than those with less experience.

Background: Concomitant use of antiretroviral (ARV) and hormonal contraceptives may change the metabolism of each and the resulting safety profiles. We evaluated the safety and tolerability of depot medroxyprogesterone acetate (DMPA) among women on ARV., Study Design: HIV-infected women on selected ARV regimens or no ARV were administered DMPA 150 mg intramuscularly and evaluated for 12 weeks for adverse events, changes in CD4+ count and HIV RNA levels, and ovulation., Results: Seventy evaluable subjects were included, 16 on nucleoside only or no ARV, 21 on nelfinavir-containing regimens, 17 on efavirenz-containing regimens and 16 on nevirapine-containing regimens. Nine Grade 3 or 4 adverse events occurred in seven subjects; none were judged related to DMPA. The most common findings possibly related to DMPA were abnormal vaginal bleeding (nine, 12.7%), headache (three, 4.2%), abdominal pain, mood changes, insomnia, anorexia and fatigue, each occurring in two (2.9%) subjects. No significant changes in CD4+ count or HIV RNA levels occurred with DMPA. No evidence of ovulation was detected, and no pregnancies occurred., Conclusions: The clinical profile associated with DMPA administration in HIV-infected women, most on ARV, appears similar to that seen in HIV-uninfected women. DMPA prevented ovulation and did not affect CD4+ counts or HIV RNA levels. In concert with previously published DMPA/ARV interaction data, these data suggest that DMPA can be used safely by HIV-infected women on the ARV studied.

Purpose: To assess the prevalence of depression among low-income, ethnic minority women with breast or gynecologic cancer, receipt of antidepressant medications or counseling services, and correlates of depression., Patients and Methods: Study patients were 472 women receiving cancer care in an urban public medical center. Women had a primary diagnosis of breast (stage 0 to III) or gynecologic cancer (International Federation of Gynecology and Obstetrics stage 0 to IIIB). A diagnostic depression screen and baseline questionnaire were administered before or during active treatment or during active follow-up. Self-report data were collected on receipt of depression treatment, use of supportive counseling, pain and receipt of pain medication, functional status and well-being, and perceived barriers to cancer care., Results: Twenty-four percent of women reported moderate to severe levels of depressive disorder (30% of breast cancer patients and 17% of gynecologic cancer patients). Only 12% of women meeting criteria for major depression reported currently receiving medications for depression, and only 5% of women reported seeing a counselor or participating in a cancer support group. Neither cancer stage nor treatment status was correlated with depression. Primary diagnosis of breast cancer, younger age, greater functional impairment, poorer social and family well-being, anxiety, comorbid arthritis, and fears about treatment side effects were correlated with depression., Conclusion: Findings indicate that depressive disorder among ethnic minority, low-income women with breast or gynecologic cancer is prevalent and is correlated with pain, anxiety, and health-related quality of life. Because these women are unlikely to receive depression treatment or supportive counseling, there is a need for routine screening, evaluation, and treatment in this population.

Background: The objective of this study was to determine the feasibility and maximum tolerated dose (MTD) of combination topotecan and pegylated liposomal doxorubicin (PLD) administered in 4- or 3-week cycles in patients with advanced or refractory solid tumors., Patients and Methods: Patients were treated with intravenous topotecan (0.75-1.25 mg/m2) for 3 days followed by PLD (25-40 mg/m2) on Day 4. The following dose combinations (topotecan/PLD, mg/m2) were explored: 0.75/40, 1.0/40, and 1.25/40 every 28 days; and 1.0/25 and 1.0/30 every 21 days., Results: Thirty-two patients were enrolled, and all had received prior chemotherapy. Most (84 percent) patients had ovarian cancer. A total of 157 cycles (median, 4 cycles; range, 1-19 cycles) of chemotherapy were administered. Dose-limiting toxicities were Grade 4 neutropenia and death at dose level 3 (1.25/40 mg/m2 every 28 days), and neutropenic fever, Grade 3 stomatitis, and Grade 3 peripheral neuropathy (all in one patient) at dose level 5 (1/30 mg/m2 every 21 days). Myelosuppression was the most common serious toxicity. Twenty-six patients were evaluable for response and 7 (27 percent) had partial responses. All responses were seen in patients with ovarian cancer., Conclusions: This combination is feasible and well tolerated; encouraging activity was observed in heavily pretreated patients with ovarian cancer. The recommended regimens for a Phase II study are topotecan 1.0 mg/m2 on Days 1-3 followed by PLD 40 mg/m2 on Day 4 of a 28-day cycle, and topotecan 1.0 mg/m2 on Days 1-3 and PLD 30 mg/m2 on Day 4 of a 21-day cycle.

Objective: The objective of this study was to assess the safety and efficacy of a novel therapeutic, ZYC101a, for the treatment of women with histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3. ZYC101a contains plasmid-DNA-encoding fragments derived from the E6 and E7 proteins of human papillomavirus (HPV) 16 and 18, and is formulated within small biodegradable microparticles., Methods: A multicenter, double-blind, randomized, placebo-controlled trial was conducted in a group of women with biopsy-confirmed CIN 2/3. Subjects were randomized to 3 intramuscular doses of either placebo or ZYC101a (100 or 200 microg). Six months after the first injection, subjects underwent cervical conization. The primary endpoint for this study was histologically confirmed resolution of CIN 2/3. A total of 161 subjects were randomized, dosed, and evaluated for safety. After central pathology review, 127 subjects were evaluable for efficacy., Results: The most common adverse events were related to the injection site, were mild to moderate, and did not worsen at later treatments. The proportion of subjects who resolved was higher in the ZYC101a groups compared to placebo (43% versus 27%), but the difference was not statistically significant (P =.12). In a prospectively defined population of women younger than 25 years (n = 43), resolution was significantly higher in the combined ZYC101a groups compared to placebo (70% versus 23%; P =.007). ZYC101a activity was not restricted to HPV-16-or HPV-18-positive lesions., Conclusions: ZYC101a was shown to be well tolerated in all patients and to promote the resolution of CIN 2/3 in women younger than 25 years., Level of Evidence: I

Background: Cervical cancer incidence and mortality rates are dramatically higher among low-income women than in the general population, in part due to poor adherence to recommended diagnostic follow-up after an index Pap test. This report describes a pilot study of the Screening Adherence Follow-Up Program (SAFe), an individualized, structured case management program designed to assess for and intervene in response to a variety of potential personal and systems barriers to follow-up adherence. Interventions included health education, counseling, and systems navigation., Methods: A clinical decision-making algorithm was used to determine service intensity and level of intervention. Services were provided to 196 low-income women, predominantly Latinas, who had either a low-grade or high-grade squamous intraepithelial lesion (LGSIL or HGSIL) abnormal Pap result. Adherence rates to at least one follow-up appointment after enrollment and baseline intervention were 83% following LGSIL and 93% for HGSIL., Results: Over 1 year post-enrollment, 41% of women with LGSIL were fully adherent, with 42% partially adherent; 61% of women with HGSIL were fully adherent, with 32% partially adherent. In a comparison group of 369 nonenrollees (women who refused participation or could not be located for consent), adherence rates were 58% for LGSIL and 67% for HGSIL. A survey among a random sample of women served indicated that 93% were "mostly" or "very" satisfied, overall, with SAFe services., Conclusions: The intervention team--a peer counselor and a master's degreed social worker--addressed multiple psychosocial and systems navigation problems to reduce potential barriers to adherence, including knowledge, attitudinal, psychosocial, psychological distress, systems communication, and resource access problems. SAFe appears highly acceptable to women and may significantly enhance medical care management following an abnormal cervical screen for a carefully targeted group of women at risk for suboptimal follow-up adherence.

Background: HIV infection and associated immunodeficiency are known to alter the course of human papillomavirus (HPV) infections and of associated diseases., Goal: This study investigated the association between HIV and HPV and genital warts., Study Design: HPV testing and physical examinations were performed in two large prospective studies: the Women's Interagency HIV Study (WIHS) and the HIV Epidemiology Research Study (HERS). Statistical methods incorporating dependencies of longitudinal data were used to examine the relationship between HIV and HPV and genital warts., Results: A total of 1008 HIV-seronegative and 2930 HIV-seropositive women were enrolled in the two studies. The prevalence of HPV 6 or 11 was 5.6 times higher in HIV-seropositive women in the WIHS and 3.6 times higher in the HERS. Genital wart prevalence increased by a factor of 3.2 in the WIHS and 2.7 in the HERS in HIV-seropositive women. In the WIHS, infection with HPV type 6 or 11, in comparison with no HPV infection, was associated with odds of genital wart prevalence of 5.1 (95% CI: 2.9-8.8), 8.8 (95% CI: 6.1-12.8), and 12.8 (95% CI: 8.8-18.8) in HIV-seronegative women, HIV-seropositive women with > or =201 CD4 cells/microl, and HIV-seropositive women with < or =200 CD4 cells/microl, respectively. In the HERS, infection with HPV type 6 or 11 was associated with odds of 2.7 (95% CI: 1.6-4.6), 4.9 (95% CI: 3.2-7.7), and 5.3 (95% CI: 3.3-8.5) in these same groups. Other HPV types showed a similar dose-response relation, but of substantially lower magnitude and statistical significance., Conclusions: HIV infection and immunodeficiency synergistically modified the relation between HPV 6 or 11 infection and genital wart prevalence.