Black Cohosh: An Uncommon Culprit of Bradycardia in Postmenopausal Women.

The use of herbal supplements has become increasingly prevalent, with black cohosh (BC) gaining popularity for managing menopausal symptoms. However, reports of adverse effects associated with BC are limited. We present a case of bradycardia linked to prolonged BC ingestion. A 76-year-old postmenopausal woman who has been taking BC for years has had syncopal attacks multiple times during the past years associated with bradycardia with the heart rate dropping to 30 beats/minute with no identifiable cause. Discontinuation of BC resulted in a gradual resolution of bradycardia, highlighting a plausible association. There were no additional pharmacological or invasive interventions required.

Effects of Pilates exercises on health-related quality of life in postmenopausal women: a systematic review and meta-analysis.

OBJECTIVE: To verify the effects of Pilates exercises on health-related quality of life (HRQoL) in postmenopausal women. METHODS: A systematic search was conducted in the following databases: PubMed, Embase, CENTRAL, CINAHL, Web of Science, LILACS, SportDiscus, Scielo, and PEDro. Randomized clinical trials (RCTs) that intervened with Pilates and had HRQoL as an outcome were eligible. The methodological quality of each RCT was assessed using the PEDro scale and the certainty of the evidence using the GRADE system. Meta-analyses were conducted by standardized mean difference (SMD). RESULTS: Initially, 760 records were located. After screening, 11 RCTs were included in the systematic review. Five studies presented low risk of bias (PEDro score ≥ 6). Evidence of very low to moderate certainty demonstrated significant effects in favor of Pilates exercises vs control groups for five of the nine HRQoL domains analyzed: bodily pain (SMD = 0.96), physical functioning (SMD = 0.85), social functioning (SMD = 0.45), role physical (SMD = 0.79), and role emotional (SMD = 0.61). Subgroup analyzes demonstrated that Pilates had a positive impact on more domains whens administered for ≥ 48 sessions (eight domains) vs < 48 sessions (three domains); and when administered on equipment (seven domains) vs mat (three domains). CONCLUSION: Pilates exercises, in general, allowed significant effects to improve HRQoL in postmenopausal women, especially when performed on equipment and when administered for at least 48 sessions. However, no analysis showed high certainty of evidence, and more RCTs of high methodological quality are needed to confirm these findings.

Estrone-mediated lowering of ROS and NOX4 improves endothelial function in ovariectomized wistar rats.

Estrone (E1) constitutes the primary component in oral conjugated equine estrogens (CEEs) and serves as the principal estrogen precursor in the female circulation in the post-menopause. E1 induces endothelium-dependent vasodilation and activate PI3K/NO/cGMP signaling. To assess whether E1 mitigates vascular dysfunction associated with postmenopause and explore the underlying mechanisms, we examined the vascular effects of E1 in ovariectomized (OVX) rats, a postmenopausal experimental model. Blood pressure was measured using tail-cuff plethysmography, and aortic rings were isolated to assess responses to phenylephrine, acetylcholine (ACh), and sodium nitroprusside. Responses to ACh in rings pre-incubated with superoxide dismutase (SOD), catalase (CAT), or apocynin were also evaluated. Protein expression of SOD, CAT, NOX1, NOX2, and NOX4 was determined by Western blotting. E1 treatment resulted in decreased body weight and retroperitoneal fat, increased uterine weight, and prevented elevated blood pressure in the OVX group. Furthermore, E1 improved endothelium-dependent ACh vasodilation, activated compensatory antioxidant mechanisms - i.e. increased SOD and CAT antioxidant enzymes activity, and decreased NOX4 expression. This, in turn, helped prevent oxidative stress and endothelial dysfunction in OVX rats. Additionally, E1 treatment reversed the increased total LDL cholesterol observed in the OVX group. The findings underscore protective effects of E1 on the cardiovascular system, counteracting OVX-related oxidative stress and endothelial dysfunction in Wistar rats. E1 exhibits promising therapeutic benefits for managing cardiovascular health, particularly in postmenopausal conditions.

An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause.

OBJECTIVES: The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause. STUDY DESIGN: Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial. MAIN OUTCOME MEASURES: During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied. RESULTS: A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred. CONCLUSION: Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active. CLINICALTRIALS: gov identifier NCT05211505.

An Unusual Presentation of Choriocarcinoma in a Postmenopausal Woman: A case report.

Choriocarcinoma (CC) is a malignant neoplasm of the trophoblastic tissue, with a potential to metastasise to distant organs. Limited case of gestational CC develops after a long latent period. We report a 52-year-old postmenopausal woman who developed metastatic choriocarcinoma presumably of gestational origin, 8 years after the last pregnancy and 2 years after the last menstrual period. The patient was brought to the emergency room of a tertiary care centre in Muscat, Oman, in 2022 and was diagnosed with CC metastatic to the brain, spleen, lung and the kidney. The ß-human chorionic gonadotrophin level was found to be raised (1,292,867 mIU/mL). The International Federation of Gynecologic Oncology risk score was calculated to be 14 (very high risk). The patient was initially treated with whole-brain radiotherapy and splenic artery embolisation because of a hemoperitoneum. Afterwards the patient received systemic treatment using the standard EMA/CO regimen till complete serological remission.

Exploring the unusual: a testosterone-secreting ovarian tumor.

Ovarian steroid cell tumors are rare, representing less than 0.1% of all ovarian neoplasms. Among the myriad causes of hirsutism, ovarian tumors account for 1% of the reported cases. We present the case of a 49-year-old parous postmenopausal woman who sought medical attention for hirsutism for 2 years. This case illustrates the unusual and interesting connection between rare ovarian pathology and the clinical manifestation of hirsutism in a postmenopausal patient. Her ultrasonography and MRI showed a right adnexal mass of solid-cystic consistency with thin septations. Her laboratory workup revealed high levels of total testosterone of 256 ng/ml (8.4-48.1ng/ml) and free testosterone of 7.36 pg/ml (0.2-4.1 pg/ml), while DHEAS - 234 µg/dl (35.4-256 µg/dl) and CA125 - 15.8U/L (0.0-35 U/L) were in the normal range. She underwent exploratory laparotomy with a total abdominal hysterectomy and oophorectomy. Histopathological examination and immunohistochemistry conclusively established the presence of a steroid cell tumor, specifically classified as "Not Otherwise Specified"(NOS), in the right ovary.

Uterine Lipoleiomyoma: A Case Report and Review of the Literature.

Uterine leiomyomas are the most common benign neoplasms found in women of reproductive age. Lipoleiomyoma, a rare variant of leiomyomas, is composed of intermixed smooth muscle cells and mature adipocytes. These neoplasms are usually discovered incidentally in obese, perimenopausal, or postmenopausal women. In this report, we present a case of lipoleiomyoma in a postmenopausal woman who presented with vaginal bleeding and back pain.

Women´s experiences of menopause: A qualitative study among women in Soweto, South Africa.

Women today are experiencing menopause for decades more than in previous generations. This 'change of life' is defined by an entire stage of physical, hormonal, and emotional changes that accompany menstrual irregularity and the cessation of fertility, although limited medical research has focused on it. Yet, the inevitability of menopause is universal for all human females around 50 years old. In this article, we conducted twenty-five 20-60 min semi-structured qualitative interviews. Most women marked menopause by fertility cessation and social transition to old age, pushing back against a medical framework of menopause that emphasises hormonal deficiency and becoming disordered. In contrast, women frame menopause as a natural process that contributes to a critical social role transition, which they perceive as deeply private in part because it is associated with a reduction in femininity, sexuality, and power. On the other hand, menopause was also described as a liberating process through which women no longer needed to purchase pads or manage blood loss. Recognising how women may perceive menopause not as a deficit or disorder but as a social role transition that has both costs and benefits is useful for medical practitioners when discussing clinical options.

Association between personality traits and psychological distress among postmenopausal women with coronary heart disease: A cross-sectional survey and mediation analysis.

Postmenopausal women with negative personality characteristics are at an increased risk of psychological disorders, yet little is known about the mechanism underlying the relationship between type D personality and psychological distress in postmenopausal women with coronary disease. This study assessed the mediating roles of perceived social support and self-perceived burden in the relationship between type D and psychological distress based on the equity theory and stress-buffering model. Demographic characteristics, type D, psychological distress, perceived social support, and self-perceived burden were completed by 335 participants with self-reported questionnaires using a cross-sectional design in Southeast China. The results revealed that perceived social support and self-perceived burden both separately and serially mediated the relationship between type D personality and psychological distress. Effective intervention strategies aimed at improving perceived social support or reducing self-perceived burden may be beneficial in reducing psychological distress.

Effect of fasting glucose levels on carotid intima-media thickness in premenopausal versus postmenopausal women.

Objective: To investigate the relationship between fasting blood glucose (FBG) and carotid intimamedia thickness (IMT) in premenopausal and postmenopausal women. Subjects and methods: The study enrolled 2,959 women seen at the Maanshan People's Hospital of Anhui Province from December 2013 to December 2018. Carotid IMT was measured using Doppler ultrasound. Linear regression and R smoothing curves were used to analyze the relationship between blood glucose level and carotid IMT in the premenopausal and postmenopausal groups. Results: Postmenopausal compared with premenopausal women had higher mean IMT (mIMT; 0.81 ± 0.23 mm versus 0.70 ± 0.14 mm, respectively, p < 0.001) and maximum IMT (maxIMT; 0.86 ± 0.35 mm versus 0.74 ± 0.16 mm, respectively, p < 0.001) values. On linear regression analysis, mIMT values increased with increasing FBG values when FBG level was ≤ 7 mmol/L, but no significance was found between FBG and maxIMT. After stratification by menopausal status, mIMT and maxIMT increased with increasing FBG when FBG was ≤ 7 mmol/L in the premenopausal group. In the postmenopausal group, mIMT and maxIMT increased with increasing FBG. After adjustment for covariate factors, the relationship between FBG and mIMT remained the same as before the adjustment, but when FBG was ≤ 11 mmol/L, the maxIMT increased with increasing FBG. In the stratification analysis, maxIMT increased with increasing FBG when FBG was ≤ 7 mmol/L in the premenopausal group, while both mIMT and maxIMT increased with increasing FBG when FBG was > 10 mmol/L in the postmenopausal group. Conclusion: Levels of FBG contributed more to increased IMT in postmenopausal than premenopausal women. The influence of FBG was greater on maxIMT than mIMT. Additionally, FBG was helpful in assessing focal thickening of the carotid intima.

Menopause and the role of physical activity - The views and knowledge of women aged 40-65.

Menopause marks the end of female reproductive capacity. It is defined as the point after cessation of the menstrual cycle for 12 months (Nursat et al., 2008). Awareness about menopause has increased over the last decade, yet studies have shown that women still lack knowledge regarding the subject. Likewise, awareness of women between the age of 40-65 on the potential role of physical activity prior to and during menopause in women is unclear. Women (n = 162) aged 40-65 years completed a survey rating their knowledge, answered fact-based questions and reported their experiences of menopause. Their levels of, and beliefs on, the role physical activity on symptoms and menopause associated disease risk were also collected. Women reported their confidence in their current knowledge level at 67% reflecting 37% higher rating than an estimate of their knowledge 10 years ago. Their factual knowledge score was 56%. Knowledge was primarily gained through friends and family and almost half (46%) had not spoken to a healthcare professional. Frustration was expressed with lack of knowledge and support of healthcare and others. Women using HRT (44%) had mixed attitudes towards its role. A high proportion were active and felt that physical activity can help manage symptoms and impact long-term health consequences of menopause. Menopause education strategies for women, healthcare professionals and others need to be improved. Lack of education may be causing women to struggle and feel negatively towards this life stage. Physical activity was viewed positively for the symptoms and a treatment during menopause and long-term health.

Association of Four Interleukin-8 Polymorphisms (-251 A>T, +781 C>T, +1633 C>T, +2767 A>T) with Ovarian Cancer Risk: Focus on Menopausal Status and Endometriosis-Related Subtypes.

Interleukin-8 (IL-8) is involved in the regulation of inflammatory processes and carcinogenesis. Single-nucleotide polymorphisms (SNPs) within the IL-8 gene have been shown to alter the risks of lung, gastric, or hepatocellular carcinomas. To date, only one study examined the role of IL-8 SNPs in ovarian cancer (OC), suggesting an association between two IL-8 SNPs and OC risk. In this study, we investigated four common IL-8 SNPs, rs4073 (-251 A>T), rs2227306 (+781 C>T), rs2227543 (+1633 C>T), and rs1126647 (+2767 A>T), using the restriction fragment length polymorphism (PCR-RFLP) technique. Our study included a cohort of 413 women of Central European descent, consisting of 200 OC patients and 213 healthy controls. The most common (73.5%) histological type was high-grade serous OC (HGSOC), whereas 28/200 (14%) patients had endometriosis-related (clear cell or endometrioid) OC subtypes (EROC). In postmenopausal women, three of the four investigated SNPs, rs4073 (-251 A>T), rs2227306 (+781 C>T), and rs2227543 (+1633 C>T), were associated with OC risk. Furthermore, we are the first to report a significant relationship between the T allele or TT genotype of SNP rs1126647 (+2767 A>T) and the EROC subtype (p = 0.02 in the co-dominant model). The TT homozygotes were found more than twice as often in EROC compared to other OC subtypes (39% vs. 19%, p = 0.015). None of the examined SNPs appeared to influence OC risk in premenopausal women, nor were they associated with the aggressive HGSOC subtype or the stage of disease at the initial diagnosis.

Hormone Replacement Therapy and Risks of Various Cancers in Postmenopausal Women with De Novo or a History of Endometriosis.

This study examined the impact of hormone replacement therapy (HRT) on the occurrence of various cancers in postmenopausal women with de novo or a history of endometriosis. In the datasets for ten cancers (cervical, uterine, ovarian, breast, colon, gastric, liver, lung, pancreatic, and thyroid), women who received HRT (the HRT group) and those who did not (the control group) were selected by a 1:1 matching with those who met the study criteria. In the dataset for each cancer, the incidence of each cancer was very low (0.2% to 1.5% in the HRT group and 0.2% to 1.3% in the control group). The duration of HRT was 1.3 ± 2.1 years. After adjusting for co-variables, HRT was a significant risk factor for uterine cancer (p < 0.05). However, the risk of liver cancer decreased significantly with duration of HRT (p < 0.05). Moreover, combined estrogen and progesterone decreased the risks of liver and thyroid cancers significantly (p < 0.05), and estrogen alone decreased the risks of breast and lung cancers significantly (p < 0.05). Tibolone was not associated with the risk of any of the cancers assessed. These results can help guide the use of HRT in women with de novo or a history of endometriosis.

Sharing the multidisciplinary clinical approach to peri- and postmenopausal women: A Delphi consensus among Italian gynecologists, endocrinologists, and cardiologists for an integrated and optimal approach to clinical practice.

OBJECTIVE: The critical phase of perimenopausal period is marked by a reduction in estrogen levels, leading to various clinical issues (vasomotor and neurodegenerative symptoms, increased osteoporosis risk and cardiovascular risk). These complex clinical scenarios pose challenges to clinicians in providing the right support for diagnosis and treatment. A group of Italian cardiologists, endocrinologists, and gynecologists conducted a survey among expert colleagues to assess consensus on controversial issues and best practices for screening and treating peri- and postmenopausal women. METHODS: The Delphi methodology was used to analyze responses from a qualitative expert panel comprising 25 cardiologists, 25 endocrinologists, and 25 gynecologists, selected nationwide. Two consecutive questionnaires were proposed between February and May 2023. Agreement among experts was assessed following the Delphi method as developed by the RAND Corporation. RESULTS: The results of this Delphi Consensus have been shared by the leading scientific societies: Italian Society of Cardiology, Italian Society of Endocrinology, Italian Society of Gynecology and Obstetrics, and Italian Hospital Obstetricians Gynecologists Association. CONCLUSIONS: The experts highlighted comorbidities and hormone deprivation as crucial clinical problems to be evaluated in perimenopausal women, requiring investigation from cardiovascular and endocrinologic perspectives to assess cardiovascular risk, involving the use of BMI, standard blood samples, endocrine-metabolic tests, and lifestyle assessment, particularly in women with higher cardiovascular and metabolic risks candidates for hormone replacement therapy (HRT). The experts also agreed on the benefits of HRT in improving lipid metabolism and reducing insulin resistance, thereby mitigating the metabolic risks associated with menopause. However, this therapy should be tailored considering individual women's comorbidities and thrombotic risk.

BMI and breast cancer risk around age at menopause.

BACKGROUND: A high body mass index (BMI, kg/m2) is associated with decreased risk of breast cancer before menopause, but increased risk after menopause. Exactly when this reversal occurs in relation to menopause is unclear. Locating that change point could provide insight into the role of adiposity in breast cancer etiology. METHODS: We examined the association between BMI and breast cancer risk in the Premenopausal Breast Cancer Collaborative Group, from age 45 up to breast cancer diagnosis, loss to follow-up, death, or age 55, whichever came first. Analyses included 609,880 women in 16 prospective studies, including 9956 who developed breast cancer before age 55. We fitted three BMI hazard ratio (HR) models over age-time: constant, linear, or nonlinear (via splines), applying piecewise exponential additive mixed models, with age as the primary time scale. We divided person-time into four strata: premenopause; postmenopause due to natural menopause; postmenopause because of interventional loss of ovarian function (bilateral oophorectomy (BO) or chemotherapy); postmenopause due to hysterectomy without BO. Sensitivity analyses included stratifying by BMI in young adulthood, or excluding women using menopausal hormone therapy. RESULTS: The constant BMI HR model provided the best fit for all four menopausal status groups. Under this model, the estimated association between a five-unit increment in BMI and breast cancer risk was HR=0.87 (95% CI: 0.85, 0.89) before menopause, HR=1.00 (95% CI: 0.96, 1.04) after natural menopause, HR=0.99 (95% CI: 0.93, 1.05) after interventional loss of ovarian function, and HR=0.88 (95% CI: 0.76, 1.02) after hysterectomy without BO. CONCLUSION: The BMI breast cancer HRs remained less than or near one during the 45-55 year age range indicating that the transition to a positive association between BMI and risk occurs after age 55.

Comparative analysis of pelvic floor muscle training and Pilates in managing urinary incontinence among postmenopausal women: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: This study is aimed at comparing the effectiveness of pelvic floor muscle training (PFMT) and Pilates on the improvement of urinary incontinence (UI), strength, and endurance of the pelvic floor muscles (PFMs), and the impact of UI on the quality of life in postmenopausal women. METHODS: Forty postmenopausal women were randomly divided in to two groups: PFMT (n = 20) and Pilates (n = 20). The participants were followed for 12 weeks, three times a week on nonconsecutive days. UI was assessed using the pad test and the voiding diary, PFM strength and resistance using bidigital assessment and manometry, and the impact of UI on quality of life using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), before and after the 3-month treatment. RESULTS: There was a significant intra-group improvement in both groups for the pad test, mean daily urinary loss, and ICIQ-SF. The strength was significantly improved only in the PFMT group, and the endurance in both groups. Peak strength manometry was significantly improved only in the Pilates group, and the mean strength manometry in both groups. There was also an improvement in both groups for peak endurance manometry and mean endurance manometry. In the inter-group comparison, there was a significant improvement only in muscle strength, which was positive for group. CONCLUSIONS: There was no difference between Pilates and PFMT for the management of women in post-menopause with stress urinary incontinence, provided that voluntary contraction of the PFMs is performed. However, further randomized clinical trials need to be carried out.

Lower Urinary Tract Symptoms in Greek Women After Menopause: The LADY Study.

INTRODUCTION AND HYPOTHESIS: The genitourinary syndrome of menopause (GSM), apart from symptoms related to vulvovaginal atrophy (VVA), also consists of lower urinary tract symptoms (LUTS). Based on the common embryological origin of the genital and lower urinary system, the presence of estrogen receptors, and the high prevalence of VVA and LUTS in the menopausal population, the two conditions can coexist. This study is aimed at investigating the prevalence and risk factors of LUTS in a sample of Greek peri- and postmenopausal women. METHODS: Four hundred and fifty (450) women, aged 40-70 years, attending three outpatient gynecology clinics for routine examination, completed a structured interview and responded to a validated questionnaire (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms, ICIQ-FLUTS). RESULTS: Urinary urgency or frequency affected 51.6% and dysuria 43.6% of the participants. Mild urgency or frequency was described by 25.6%, moderate by 14.4%, and severe by 11.6% of the women. Mild dysuria was reported by 26.26%, moderate by 5.8%, and severe by 11.6%. Age, weight, BMI, and number of pregnancies and abortions correlated with a higher ICIQ-FLUTS score. Women with moderate/severe symptoms of VVA, such as irritation, a burning sensation, and pruritus of the vulva or vagina, had a higher ICIQ-FLUTS score than women without such symptoms (beta coefficient 2.42, CI 1.204, 3.635, p < 0.001). CONCLUSIONS: Lower urinary tract symptoms are very common among peri- and postmenopausal women and are linked to symptoms of VVA. Our data support the need for prompt evaluation of women transitioning to menopause, as these symptoms compromise the quality of life.

How do women feel cold water swimming affects their menstrual and perimenopausal symptoms?

OBJECTIVE: This study aimed to determine how women felt cold water swimming affected their menstrual and perimenopausal symptoms. STUDY DESIGN: An online survey that asked women who regularly swim in cold water about their experiences. The survey was advertised for 2 months on social media. Questions related to cold water swimming habits and menstrual and perimenopausal symptoms were analysed. MAIN OUTCOME MEASURES: Quantitative and qualitative data including; frequency of menstrual and menopause symptoms, the effect of cold water swimming on these symptoms. RESULTS: 1114 women completed the survey. Women reported that cold water swimming reduced their menstrual symptoms, notably psychological symptoms such as anxiety (46.7%), mood swings (37.7%) and irritability (37.6%). Perimenopausal women reported a significant improvement in anxiety (46.9%), mood swings (34.5%), low mood (31.1%) and hot flushes (30.3%). The majority of women with symptoms swam specifically to reduce these symptoms (56.4% for period and 63.3% for perimenopause symptoms). Women said they felt it was the physical and mental effects of the cold water that helped their symptoms. For the free text question, five themes were identified: the calming and mood-boosting effect of the water, companionship and community, period improvements, an improvement in hot flushes and an overall health improvement. CONCLUSION: Women felt that cold water swimming had a positive overall effect on menstrual and perimenopause symptoms. Studies on other forms of exercise to relieve menstrual and perimenopause symptoms may show similar findings.

Sex-Based Analysis of Workflow and Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase Versus Tenecteplase.

BACKGROUND: Understanding sex differences in stroke care is important in reducing potential disparities. Our objective was to explore sex differences in workflow efficiency, treatment efficacy, and safety in the AcT trial (Alteplase Compared to Tenecteplase). METHODS: AcT was a multicenter, registry-linked randomized noninferiority trial comparing tenecteplase (0.25 mg/kg) with alteplase (0.9 mg/kg) in acute ischemic stroke within 4.5 hours of onset. In this post hoc analysis, baseline characteristics, workflow times, successful reperfusion (extended Thrombolysis in Cerebral Infarction score ≥2b), symptomatic intracerebral hemorrhage, 90-day functional independence (modified Rankin Scale score, 0-1), and 90-day mortality were compared by sex. Mixed-effects regression analysis was used adjusting for age, stroke severity, and occlusion site for outcomes. RESULTS: Of 1577 patients treated with intravenous thrombolysis (2019-2022), 755 (47.9%) were women. Women were older (median, 77 [68-86] years in women versus 70 [59-79] years in men) and had a higher proportion of severe strokes (National Institutes of Health Stroke Scale score >15; 32.4% versus 24.9%) and large vessel occlusions (28.7% versus 21.5%) compared with men. All workflow times were comparable between sexes. Women were less likely to achieve functional independence (31.7% versus 39.8%; unadjusted relative risk, 0.80 [95% CI, 0.70-0.91]) and had higher mortality (17.7% versus 13.3%; unadjusted relative risk, 1.33 [95% CI, 1.06-1.69]). Adjusted analysis showed no difference in outcomes between sexes. CONCLUSIONS: Differences in prognostic factors of age, stroke severity, and occlusion site largely accounted for higher functional dependence and mortality in women. No sex disparities were apparent in workflow quality indicators. Given the integration of the AcT trial into clinical practice, these results provide reassurance that no major sex biases are apparent in acute stroke management throughout participating Canadian centers. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03889249.

The prevention of rectovaginal fistula after rectal cancer surgery by packing with laparoscopic dislocated fat flap containing ovarian vascular pedicle anterior to the anastomotic stoma: a parallel group randomized controlled trial protocol.

BACKGROUND: Rectovaginal fistula (RVF) is an abnormal channel formed by epithelial tissue between the anterior wall of the rectum and the posterior wall of the vagina, which manifests as vaginal gassing and defecation. It is one of the common complications of female pelvic surgeries. With the increased number of proctectomies for rectal cancer, the number of postoperative rectovaginal fistulas also increases. Once RVF occurs, the failure rate is still high with various treatments available. RVF causes great suffering to women and is still a major problem in treatment. Therefore, it is significant for female rectal cancer patients to prevent RVF after rectal cancer surgery. In this study, we introduce a new method to prevent RVF during rectal cancer radical operation. METHODS: In this randomized controlled trial (RCT), all operations are performed according to the principle of total mesorectal excision (TME) radical resection in rectal cancer surgery. All eligible participants will be divided into two groups: the experimental group and the control group. Experimental group: the anterior rectal wall of about 1 cm distal to the anastomosis was dislocated. Before the anastomosis of the rectal end, a fat flap (usually left side) containing the ovarian vascular pedicle was dislocated, measured by 10-15 cm in length and 2 cm in width. The fat flap containing the ovarian vascular pedicle was packed and fixed anterior to the anastomotic stoma with fibrin glue. CONTROL GROUP: surgery will be carried out in accordance with the TME principle. Participants will be compared on several variables, including the incidence of RVF after operation (primary outcomes), the occurrence time of postoperative RVF, the occurrence time of RVF after stoma closure, and other postoperative complications, such as anastomotic leakage, chylous leakage, and intestinal obstruction (secondary outcomes). The follow-up data collection will be conducted according to the follow-up time point, and the baseline data will also be collected for follow-up analysis. By comparing the incidence of rectovaginal leakage between the experimental group and the control group, we aim to explore the feasibility of this method for the prevention of postoperative RVF. DISCUSSION: This RCT will explore the feasibility of packing with a laparoscopic dislocated fat flap containing an ovarian vascular pedicle anterior to the anastomotic stoma after rectal cancer surgery to prevent RVF. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR) registration ChiCTR2000031449. Registered on June 26, 2019. All items of the WHO Trial registration data set can be found within the protocol.