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1.
J Robot Surg ; 18(1): 122, 2024 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-38492079

RESUMO

The article "Comparison of operative and fertility outcomes of single-incision robotic myomectomy: a retrospective single-center analysis of 286 cases" by Kim et al. compares the effectiveness of robotic single-port myomectomy against the traditional multiport approach. The study finds similar operating outcomes, complication rates, and pregnancy rates in expert hands for both methods. Our systematic review supports these findings, revealing no significant differences in operative time, blood loss, or complication rates. Recent meta-analysis further emphasizes the benefits of the single-port approach in reducing morcellation time, overall operative duration, and blood loss. Our letter seeks insights on patient selection criteria to minimize conversion rates between surgical approaches and inquiries on learning curve differences. Additionally, we seek cost analysis details for both techniques. We appreciate the authors' valuable contributions to this field.


Assuntos
Laparoscopia , Procedimentos Cirúrgicos Robóticos , Ferida Cirúrgica , Miomectomia Uterina , Feminino , Humanos , Miomectomia Uterina/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Seleção de Pacientes , Estudos Retrospectivos , Curva de Aprendizado , Laparoscopia/métodos , Duração da Cirurgia
3.
BMC Womens Health ; 23(1): 603, 2023 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-37964227

RESUMO

BACKGROUND: At time of myomectomy, a surgical procedure to remove uterine fibroids, Black women tend to have larger uteri than White women. This makes Black patients less likely to undergo a minimally invasive myomectomy which has been shown to have less postoperative pain, less frequent postoperative fever and shorter length of stay compared to abdominal myomectomies. The associations between individual financial toxicity and community area deprivation and uterine volume at the time of myomectomy have not been investigated. METHODS: We conducted a secondary data analysis of patients with fibroids scheduled for myomectomy using data from a fibroid treatment registry in [location]. We used validated measures of individual-level Financial Toxicity (higher scores = better financial status) and community-level Area Deprivation (ADI, high scores = worse deprivation). To examine associations with log transformed uterine volume, we used linear regression clustered on race (Black vs. White). RESULTS: Black participants had worse financial toxicity, greater deprivation and larger uterine volumes compared with White participants. A greater Financial Toxicity score (better financial status) was associated with lower uterine volume. For every 10 unit increase in Financial Toxicity, the mean total uterine volume decreased by 9.95% (Confidence Interval [CI]: -9.95%, -3.99%). ADI was also associated with uterine volume. A single unit increase in ADI (worse deprivation) was associated with a 5.13% (CI: 2.02%, 7.25%) increase in mean uterine volume. CONCLUSION: Disproportionately worse Financial Toxicity and ADI among Black patients is likely due to structural racism - which now must be considered in gynecologic research and practice. TRIAL REGISTRATION: Not applicable.


Assuntos
Leiomioma , Miomectomia Uterina , Neoplasias Uterinas , Humanos , Feminino , Miomectomia Uterina/métodos , Neoplasias Uterinas/cirurgia , Estresse Financeiro , Leiomioma/cirurgia , Útero/cirurgia
4.
J Minim Invasive Gynecol ; 30(10): 813-819, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37286130

RESUMO

STUDY OBJECTIVE: Increasing evidence suggests that hysterectomy to treat uterine fibroids (UFs), even with ovarian conservation (OC), is associated with a 33% increased risk of coronary artery disease (CAD). We sought to compare the cost-effectiveness of various treatment approaches for UFs to understand the trade-offs among development of CAD vs new fibroids. DESIGN: We developed a Markov model to include women with UFs who no longer desired pregnancy. The outcomes of interest were quality-adjusted life-years (QALYs) and total treatment costs. We conducted sensitivity analyses to test the effect of uncertain model inputs. SETTING: Health system perspective. PATIENTS: A hypothetical cohort of 10 000 40-year-old women. INTERVENTIONS: Myomectomy, hysterectomy with OC, and hysterectomy without OC. MEASUREMENTS AND MAIN RESULTS: Myomectomy was the best-value strategy, costing US$528 217 and providing 19.38 QALYs. Neither hysterectomy with OC nor hysterectomy without OC was found to be cost-effective, assuming a willingness-to-pay threshold of $100 000 per QALY gain as hysterectomy with OC provided more benefit than myomectomy at an average cost of $613 144 to gain one additional QALY. The sensitivity analyses showed that if the risk of new symptomatic UFs that required treatment after myomectomy was more than 13%, annually (base case, 3.6%), or the quality of life after myomectomy was less than 0.815 (base case, 0.834), then myomectomy would no longer be cost-effective, under a willingness-to-pay amount of US$100 000. CONCLUSION: Myomectomy is an optimal treatment of UFs compared with hysterectomy among women aged 40 years. The increased risk of CAD after hysterectomy and its associated costs and the effects on morbidity and quality of life made hysterectomy a costlier and less effective long-term strategy.


Assuntos
Leiomioma , Embolização da Artéria Uterina , Miomectomia Uterina , Neoplasias Uterinas , Gravidez , Humanos , Feminino , Miomectomia Uterina/efeitos adversos , Análise Custo-Benefício , Neoplasias Uterinas/terapia , Qualidade de Vida , Resultado do Tratamento , Leiomioma/cirurgia , Histerectomia/efeitos adversos , Embolização da Artéria Uterina/efeitos adversos
5.
BMC Surg ; 23(1): 106, 2023 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-37118798

RESUMO

BACKGROUND: To compare the surgical outcomes and costs of in-bag abdominal manual morcellation (AMM) and contained power morcellation (PM) in laparoscopic myomectomy. METHODS: A total of 61 patients were divided into two groups based on their myomectomy specimen extraction methods: AMM group (n = 33) and electromechanical contained PM group (n = 28). The surgical outcomes and cost were compared between groups. During AMM, a glove bag (in 27 patients) and an endo bag were used (in 6 patients) according to the myoma size. RESULTS: Morcellation time (18 ± 9.2 min vs. 37.4 ± 14.1 min) and total operation time (100 ± 24.3 min vs. 127 ± 33.1 min) were significantly lower in the AMM group compared to those in the PM group. Other surgical outcomes, which were similar between groups, included delta hemoglobin, length of hospital stay and VAS score at 12 and 24 h postoperatively. There were no per- or postoperative complications in both group with no conversion to laparotomy. One patient was transfused with two units of erythrocyte suspension postoperatively in the PM group. Sarcoma was not diagnosed in any of the cases in both group. CONCLUSION: The in-bag AMM or contained PM for specimen extraction resulted in similar outcomes in terms of delta hemoglobin, postoperative pain intensity (VAS score at 12 and 24 h postoperatively), the need for additional analgesia, and the length of hospital stay; however, total operation time and morcellation time were significantly shorter in the AMM group, indicating a prominent advantage. Significant cost-effectiveness is also a critical advantage of in-bag AMM compared to containing PM.


Assuntos
Laparoscopia , Leiomioma , Morcelação , Miomectomia Uterina , Neoplasias Uterinas , Feminino , Humanos , Miomectomia Uterina/métodos , Morcelação/métodos , Leiomioma/cirurgia , Neoplasias Uterinas/cirurgia , Laparoscopia/métodos , Resultado do Tratamento , Hemoglobinas , Histerectomia
6.
Eur J Obstet Gynecol Reprod Biol ; 280: 179-183, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36512958

RESUMO

OBJECTIVE: To assess the utilization and cost of intraoperative cell salvage (ICS) in minimally invasive myomectomy. STUDY DESIGN: Retrospective cohort study of patients who underwent minimally invasive myomectomy at a quaternary care academic hospital. Patients were classified into: ICS setup vs no ICS setup, ICS setup with reinfusion vs ICS setup without reinfusion. RESULTS: Of 382 patients who underwent minimally invasive myomectomy, 67 (17.5 %) had ICS setup, 30 (44.8 %) of those patients reinfused. Median volume of reinfusion per patient was 300 mL (range 125-1000 mL). Patients who ultimately underwent ICS reinfusion, compared to those with ICS setup only, had significantly larger mean maximum fibroid size (9.8 cm vs 8.0 cm, p = 0.02), higher median total specimen weight (367 vs 304 g, p = 0.03), higher median estimated blood loss (575 vs 300 mL, p < 0.0001), longer mean operative time (261 vs 215 min, p = 0.04). No perioperative complications were associated with ICS. Higher costs are associated with universal use or complete lack of ICS; lowest cost is associated with ICS setup only for those ultimately reinfused. CONCLUSION: ICS might reduce requirements for allogeneic blood transfusions in patients undergoing minimally invasive myomectomy, and may contribute to cost savings. Uterine and maximum fibroid sizes are possible preoperative indicators for patients who require cell salvage reinfusion.


Assuntos
Leiomioma , Miomectomia Uterina , Neoplasias Uterinas , Feminino , Humanos , Estudos Retrospectivos , Leiomioma/cirurgia , Útero , Transfusão de Sangue , Neoplasias Uterinas/cirurgia
7.
J Minim Invasive Gynecol ; 29(10): 1157-1164, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35781056

RESUMO

STUDY OBJECTIVE: To assess rates of and factors associated with complications and reoperation after myomectomy. DESIGN: Population-based cohort study. SETTING: All non-Veterans Affairs facilities in the state of California from January 1, 2005, to December 31, 2018. PARTICIPANTS: Women undergoing abdominal or laparoscopic myomectomy for myoma disease were identified from the Office of Statewide Health Planning and Development datasets using appropriate International Classification of Diseases, Ninth and Tenth Revision and Current Procedural Terminology codes. INTERVENTIONS: Demographics, surgery facility type, facility surgical volume, and surgical approach were identified. Primary outcomes included complications occurring within 60 days of surgery and reoperations for myomas. Patients were followed up for over an average of 7.3 years. Univariate and multivariable associations were explored between the above factors and rates of complications and reoperation. All odds ratios (ORs) are adjusted ORs. MEASUREMENTS AND MAIN RESULTS: Of the 66 012 patients undergoing myomectomy, 5265 had at least one complication (8.0%). Advanced age, black, Asian race, MediCal and Medicare payor status, academic facility, and medical comorbidities were associated with increased odds of a complication. Minimally invasive myomectomy (MIM) was associated with decreased complications compared with abdominal myomectomy (AM) (OR, 0.29; 95% confidence interval [CI], 0.25-0.33; p <.001). Overall, 17 377 patients (26.3%) underwent reoperation. Medicare and MediCal payor status and medical comorbidities were associated with increased odds of a repeat surgery. Reoperation rates were higher in the MIM group over the entire study period (OR, 2.33; 95% CI, 1.95-2.79; p <.001). However, the odds of reoperation after MIM decreased each year (OR, 0.93; 95% CI 0.92-0.95; p <.001), with the odds of reoperation after AM surpassing MIM in 2015. CONCLUSION: This study identifies outcome disparities in the surgical management of myomas and describes important differences in the rates of complications and reoperations, which can be used to counsel patients on surgical approach. These findings suggest that MIM can be considered a lasting and safe approach in properly selected patients.


Assuntos
Laparoscopia , Leiomioma , Mioma , Miomectomia Uterina , Neoplasias Uterinas , Idoso , Feminino , Humanos , Estudos de Coortes , Eletrólitos , Laparoscopia/efeitos adversos , Leiomioma/etiologia , Leiomioma/cirurgia , Medicare , Mioma/cirurgia , Reoperação , Estudos Retrospectivos , Estados Unidos , Miomectomia Uterina/efeitos adversos , Neoplasias Uterinas/etiologia , Neoplasias Uterinas/cirurgia
8.
J Minim Invasive Gynecol ; 29(9): 1104-1109, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35691547

RESUMO

STUDY OBJECTIVE: To determine whether surgical management of abnormal uterine bleeding (AUB) is associated with social vulnerability index (SVI). DESIGN: A retrospective cohort. SETTING: A total of 7 hospitals and 4 ambulatory surgery centers within a large New York health system. PATIENTS: All patients between 15 and 45 years of age who underwent either a hysterectomy or myomectomy for AUB between January 2019 and October 2021. INTERVENTIONS: None. Home addresses were linked to census tracts and SVI scores. SVI is composed of 4 themes that potentially influence a community's vulnerability to health stressors: socioeconomic status, household composition and disability, minority status and language, and housing type and transportation. Multiple logistic regression analyses were performed to evaluate the association between SVI and surgical procedure/approach, adjusting for age, race and ethnicity, marital status, insurance, language, body mass index, and previous abdominal surgery. MEASUREMENTS AND MAIN RESULTS: A total of 1628 patients were included. On performing regression analysis between SVI quarters and type of surgery, the odds of undergoing laparotomy for the hysterectomy group were not affected by SVI composite score both before and after adjusting for alternative factors (odds ratio [OR] and adjusted OR). Among those who had a myomectomy, individuals in SVI Q3 had 1.86 times (95% confidence interval, 1.27-2.72) higher odds of having a laparotomy than those in SVI Q1. Individuals in SVI Q4 had 1.74 times (95% confidence interval, 1.15-2.62) higher odds of having a laparotomy than those in SVI Q1. Although some unadjusted ORs were statistically significant in the myomectomy group, when adjusted for social, demographic, and economic factors, the results were not statistically significant. CONCLUSION: Patients living in more vulnerable communities are less likely to have minimally invasive hysterectomy or myomectomy for the management of AUB. Neighborhood characteristics are independently associated with surgical procedure and approach.


Assuntos
Vulnerabilidade Social , Miomectomia Uterina , Feminino , Humanos , Histerectomia/métodos , Estudos Retrospectivos , Hemorragia Uterina/cirurgia , Miomectomia Uterina/métodos
9.
Health Technol Assess ; 26(22): 1-74, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35435818

RESUMO

BACKGROUND: Uterine fibroids are the most common tumour in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort, subfertility and reduced quality of life. For women wishing to retain their uterus and who do not respond to medical treatment, myomectomy and uterine artery embolisation are therapeutic options. OBJECTIVES: We examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids. DESIGN: A multicentre, open, randomised trial with a parallel economic evaluation. SETTING: Twenty-nine UK hospitals. PARTICIPANTS: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolisation were recruited. Women were excluded if they had significant adenomyosis, any malignancy or pelvic inflammatory disease or if they had already had a previous open myomectomy or uterine artery embolisation. INTERVENTIONS: Participants were randomised to myomectomy or embolisation in a 1 : 1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic. Embolisation of the uterine arteries was performed under fluoroscopic guidance. MAIN OUTCOME MEASURES: The primary outcome was the Uterine Fibroid Symptom Quality of Life questionnaire (with scores ranging from 0 to 100 and a higher score indicating better quality of life) at 2 years, adjusted for baseline score. The economic evaluation estimated quality-adjusted life-years (derived from EuroQol-5 Dimensions, three-level version, and costs from the NHS perspective). RESULTS: A total of 254 women were randomised - 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolisation (98 underwent embolisation). Information on the primary outcome at 2 years was available for 81% (n = 206) of women. Primary outcome scores at 2 years were 84.6 (standard deviation 21.5) in the myomectomy group and 80.0 (standard deviation 22.0) in the uterine artery embolisation group (intention-to-treat complete-case analysis mean adjusted difference 8.0, 95% confidence interval 1.8 to 14.1, p = 0.01; mean adjusted difference using multiple imputation for missing responses 6.5, 95% confidence interval 1.1 to 11.9). The mean difference in the primary outcome at the 4-year follow-up time point was 5.0 (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. Perioperative and postoperative complications from all initial procedures occurred in similar percentages of women in both groups (29% in the myomectomy group vs. 24% in the UAE group). Twelve women in the uterine embolisation group and six women in the myomectomy group reported pregnancies over 4 years, resulting in seven and five live births, respectively (hazard ratio 0.48, 95% confidence interval 0.18 to 1.28). Over a 2-year time horizon, uterine artery embolisation was associated with higher costs than myomectomy (mean cost £7958, 95% confidence interval £6304 to £9612, vs. mean cost £7314, 95% confidence interval £5854 to £8773), but with fewer quality-adjusted life-years gained (0.74, 95% confidence interval 0.70 to 0.78, vs. 0.83, 95% confidence interval 0.79 to 0.87). The differences in costs (difference £645, 95% confidence interval -£1381 to £2580) and quality-adjusted life-years (difference -0.09, 95% confidence interval -0.11 to -0.04) were small. Similar results were observed over the 4-year time horizon. At a threshold of willingness to pay for a gain of 1 QALY of £20,000, the probability of myomectomy being cost-effective is 98% at 2 years and 96% at 4 years. LIMITATIONS: There were a substantial number of women who were not recruited because of their preference for a particular treatment option. CONCLUSIONS: Among women with symptomatic uterine fibroids, myomectomy resulted in greater improvement in quality of life than did uterine artery embolisation. The differences in costs and quality-adjusted life-years are very small. Future research should involve women who are desiring pregnancy. TRIAL REGISTRATION: This trial is registered as ISRCTN70772394. FUNDING: This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in Health Technology Assessment; Vol. 26, No. 22. See the NIHR Journals Library website for further project information.


WHAT IS THE PROBLEM?: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. Uterine fibroids are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (via myomectomy) or to completely remove the womb. A newer approach, known as uterine artery embolisation, involves blocking the blood supply to the fibroids in the womb. WHAT DID WE PLAN TO DO?: We compared myomectomy with uterine artery embolisation in women with fibroids who wanted to keep their womb. We wanted to see which treatment improved quality of life, was associated with the fewest complications and was the best value for money for the NHS. We also wanted to see if either treatment had an impact on women's ability to get pregnant and give birth. We included 254 women in a clinical trial. Women were assigned to have myomectomy or uterine artery embolisation at random to ensure a fair comparison. Women completed questionnaires about their symptoms and quality of life at intervals up to 4 years after treatment. WHAT DID WE FIND?: We found that myomectomy improved women's quality of life more than uterine artery embolisation. Complications from the treatments occurred in a similar proportion of women. There appeared to be no difference on reproductive hormone levels between treatments. Too few women in the trial got pregnant for any difference in the numbers of women having children to be seen. The differences in costs and overall disease burden were small. WHAT DOES THIS MEAN?: Both treatments improve quality of life and cost about the same to the NHS but, on average, myomectomy will provide greater benefit to women. There is no evidence to suggest that either treatment is unsuitable for women wanting to get pregnant, but more research is needed in younger women.


Assuntos
Leiomioma , Embolização da Artéria Uterina , Miomectomia Uterina , Feminino , Humanos , Histerectomia , Leiomioma/cirurgia , Masculino , Gravidez , Qualidade de Vida
10.
J Obstet Gynaecol ; 42(1): 153-157, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33938365

RESUMO

The current study aimed to analyse and compare the vascularity of FIGO Type 4-7 leiomyoma specimens obtained from women with or without abnormal uterine bleeding (AUB). The records of 31 women who underwent myomectomy for FIGO Type 4-7 leiomyomas in a university hospital setting were analysed. Group I (n = 16) was composed of women that were symptomatic for AUB and group II (n = 15) consisted of asymptomatic cases. The myomectomy material(s) of each case were processed with CD34 staining and evaluated by Image J® software (Image J 1.52a, Wayne Rasband National Institutes of Health, Bethesda, MD). There was no statistically significant difference between the rates of vascular areas in the specimens of the two groups (p>.05). Although areas with large vessels were higher in group I compared to group II, the difference did not reach statistical significance (p>.05). AUB caused by FIGO Type 4-7 leiomyomas seems to be related to factors other than vascular density.Impact StatementWhat is already known on this subject? Uterine leiomyomas are the most common benign gynaecologic neoplasms with a prevalence of approximately 40% in women of reproductive age. They are most often asymptomatic but when symptomatic, abnormal uterine bleeding (AUB) is one of the most commonly observed symptoms. Although there are some hypothetical explanations, the exact pathogenesis underlying leiomyoma-associated AUB has not yet been elucidated. Almost a century ago, the vascular abnormalities of fibroids were hypothesised as one of the etiopathological factors correlated with clinical symptoms, such as AUB, and current data suggest that the vascular map of leiomyomas consists of an avascular core surrounded by a vascularised capsule. To our knowledge, there are no studies in the literature comparing the histopathological evaluation of the vascularity scores of FIGO Type 4-7 leiomyomas in symptomatic (with AUB) and asymptomatic (without AUB) women.What the results of this study add? The study revealed that there was no statistically significant difference between the vascularity scores of FIGO Type 4-7 leiomyomas excised from the symptomatic and asymptomatic women. Large vessel densities also did not statistically significantly differ between the two groups.What the implications are of these findings for clinical practice and/or further research? This study revealed that AUB caused by FIGO Type 4-7 leiomyomas was related to factors other than vascular density.


Assuntos
Leiomioma/irrigação sanguínea , Neovascularização Patológica/patologia , Hemorragia Uterina/patologia , Miomectomia Uterina , Neoplasias Uterinas/irrigação sanguínea , Adulto , Feminino , Humanos , Leiomioma/complicações , Leiomioma/cirurgia , Pessoa de Meia-Idade , Neovascularização Patológica/complicações , Hemorragia Uterina/etiologia , Hemorragia Uterina/cirurgia , Neoplasias Uterinas/complicações , Neoplasias Uterinas/cirurgia
11.
Obstet Gynecol ; 138(6): 845-851, 2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34735384

RESUMO

OBJECTIVE: To assess the association of racial and socioeconomic factors with outcomes of abdominal myomectomies. METHODS: All women undergoing abdominal myomectomy in California from 2005 to 2012 were identified from the OSHPD (Office of Statewide Health Planning and Development) using appropriate International Classification of Diseases and Current Procedural Terminology codes. Demographics, comorbidities, surgical approaches, and complications occurring within 30 days of the procedure were identified. Multivariate associations were assessed with mixed effects logistic regression models. RESULTS: The cohort of 35,151 women was racially and ethnically diverse (White, 38.8%; Black, 19.9%; Hispanic, 20.3%; and Asian, 15.3%). Among all procedures, 33,906 were performed through an open abdominal approach, and 1,245 were performed using a minimally invasive approach. Proportionally, Black patients were more likely than White patients to have open procedures, and open approaches were associated with higher complication rates. Overall, 2,622 (7.5%) women suffered at least one complication. Although severe complications did not vary by race or ethnicity, Black (9.0%), Hispanic (7.9%), and Asian (7.5%) patients were more likely to suffer complications of any severity compared with White patients (6.7%, P<.001). As compared with patients with private insurance (6.4%), those with indigent payer status (Medicaid [12.1%] and self-pay [11.1%]) had higher complication rates (P<.001). Controlling for all factors, Black and Asian patients were more likely to suffer complications compared with White patients. CONCLUSION: The overall complication rate after abdominal myomectomy was 7.5%. Comorbidities, an open approach, and indigent payer status were associated with increased complication risk. Controlling for all factors, Black and Asian patients still had increased risks of complications.


Assuntos
Etnicidade/estatística & dados numéricos , Disparidades em Assistência à Saúde/etnologia , Complicações Pós-Operatórias/etnologia , Grupos Raciais/estatística & dados numéricos , Miomectomia Uterina/estatística & dados numéricos , Adulto , Idoso , Povo Asiático/estatística & dados numéricos , População Negra/estatística & dados numéricos , California/epidemiologia , Feminino , Hispânico ou Latino/estatística & dados numéricos , Humanos , Seguro Saúde/estatística & dados numéricos , Modelos Logísticos , Medicaid , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Fatores Socioeconômicos , Resultado do Tratamento , Estados Unidos
12.
Surg Technol Int ; 39: 34-37, 2021 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-34647309

RESUMO

INTRODUCTION: The risk of unknowingly disseminating leiomyosarcoma by morcellation in women undergoing laparoscopic hysterectomy has massively impacted gynaecological practice. Here, we present the results of an in vitro assessment of a novel protection system developed to mitigate this hazard. METHODS: The Tissue Containment System for Manual Morcellation (Guardenia™, Advanced Surgical Concepts, Wicklow, Ireland) is an evolved wound protection/specimen extraction guarded bag system compatible with any 12mm trocar. Device use was assessed by device-naïve gynaecological and general surgeon volunteers (providing expert and inexpert morcellation cohorts, respectively) on a bench model consisting of biological tissue in a custom-built moulded rig with camera control after the operators were instructed in its use. RESULTS: Twenty surgeons (10 gynaecologists/10 general surgeons, median duration of practice experience: 8 years, median annual number of laparoscopic operative procedures: 150 and 80, respectively) completed the user assessment. All subjects understood and correctly performed each step; i.e., (i) placement of the bag through the trocar, (ii) specimen bagging, (iii) incision extension (range 25-60 mm) after tethering the bag through the port, (iv) insertion of the device guard through the mouth of the bag after trocar removal, and (v) sufficient tissue morcellation within the bag to enable complete specimen removal (mean specimen weight 390g, range 201-1800g). There was 100% bag integrity by water-leak testing following use, despite scalpel contact with the guard in 14/20 cases (70%). CONCLUSION: Among first-time clinical users, this novel device enabled complete containment of morcellation debris and removal of a laparoscopic specimen, which would support further submission for regulatory approval.


Assuntos
Laparoscopia , Morcelação , Miomectomia Uterina , Neoplasias Uterinas , Feminino , Humanos , Histerectomia/efeitos adversos , Morcelação/efeitos adversos , Neoplasias Uterinas/cirurgia
13.
BJOG ; 128(11): 1793-1802, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34053154

RESUMO

OBJECTIVES: To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. DESIGN: Economic evaluation alongside the FEMME randomised controlled trial. SETTING: 29 UK hospitals. POPULATION: Premenopausal women who had symptomatic uterine fibroids amenable to UAE or myomectomy wishing to avoid hysterectomy. 254 women were randomised to UAE (127) and myomectomy (127). METHODS: A within-trial cost-utility analysis was conducted from the perspective of the UK NHS. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) measured using the EuroQoL EQ-5D-3L, combined with costs to estimate cost-effectiveness over 2 and 4 years of follow-up. RESULTS: Over a 2-year time horizon, UAE was associated with higher mean costs (difference £645; 95% CI -1381 to 2580) and lower QALYs (difference -0.09; 95% CI -0.11 to -0.04) when compared with myomectomy. Similar results were observed over the 4-year time horizon. Thus, UAE was dominated by myomectomy. Results of the sensitivity analyses were consistent with the base case results for both years. Over 2 years, UAE was associated with higher costs (difference £456; 95% CI -1823 to 3164) and lower QALYs (difference -0.06; 95% CI -0.11 to -0.02). CONCLUSIONS: Myomectomy is a cost-effective option for the treatment of uterine fibroids. The differences in costs and QALYs are small. Women should be fully informed and have the option to choose between the two procedures. TWEETABLE ABSTRACT: Fully informed women with uterine fibroids should have a choice between uterine artery embolisation or myomectomy.


Assuntos
Leiomioma/cirurgia , Embolização da Artéria Uterina/economia , Miomectomia Uterina/economia , Neoplasias Uterinas/cirurgia , Adulto , Análise Custo-Benefício , Feminino , Humanos , Leiomioma/economia , Pessoa de Meia-Idade , Pré-Menopausa , Anos de Vida Ajustados por Qualidade de Vida , Resultado do Tratamento , Neoplasias Uterinas/economia
14.
J Vasc Interv Radiol ; 31(10): 1552-1559.e1, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32917502

RESUMO

PURPOSE: To conduct a population-level analysis of surgical and endovascular interventions for symptomatic uterine leiomyomata by using administrative data from outpatient medical encounters. MATERIALS AND METHODS: By using administrative data from all outpatient hospital encounters in California (2005-2011) and Florida (2005-2014), all patients in the outpatient setting with symptomatic uterine leiomyomata were identified. Patients were categorized as undergoing hysterectomy, myomectomy, uterine artery embolization (UAE), or no intervention. Hospital stay durations and costs were recorded for each encounter. RESULTS: A total of 227,489 patients with uterine leiomyomata were included, among whom 39.9% (n = 90,800) underwent an intervention, including hysterectomy (73%), myomectomy (19%), or UAE (8%). The proportion of patients undergoing hysterectomy increased over time (2005, hysterectomy, 53.2%; myomectomy, 26.9%; UAE, 18.0%; vs 2013, hysterectomy, 80.1%; myomectomy, 14.4%; UAE, 4.0%). Hysterectomy was eventually performed in 3.5% of patients who underwent UAE and 4.1% who underwent myomectomy. Mean length of stay following hysterectomy was significantly longer (0.5 d) vs myomectomy (0.2 d) and UAE (0.3 d; P < .001 for both). The mean encounter cost for UAE ($3,772) was significantly less than those for hysterectomy ($5,409; P < .001) and myomectomy ($6,318; P < .001). Of the 7,189 patients who underwent UAE during the study period, 3.5% underwent subsequent hysterectomy. CONCLUSIONS: The proportion of women treated with hysterectomy in the outpatient setting has increased since 2005. As a lower-cost alternative with a low rate of conversion to hysterectomy, UAE may be an underutilized treatment option for patients with uterine leiomyomata.


Assuntos
Procedimentos Endovasculares/tendências , Histerectomia/tendências , Leiomioma/terapia , Padrões de Prática Médica/tendências , Embolização da Artéria Uterina/tendências , Miomectomia Uterina/tendências , Neoplasias Uterinas/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , California , Redução de Custos , Análise Custo-Benefício , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/economia , Feminino , Florida , Custos Hospitalares/tendências , Humanos , Histerectomia/efeitos adversos , Histerectomia/economia , Leiomioma/economia , Tempo de Internação , Pessoa de Meia-Idade , Saúde da População , Complicações Pós-Operatórias/etiologia , Padrões de Prática Médica/economia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Embolização da Artéria Uterina/efeitos adversos , Embolização da Artéria Uterina/economia , Miomectomia Uterina/efeitos adversos , Miomectomia Uterina/economia , Neoplasias Uterinas/economia , Adulto Jovem
15.
N Engl J Med ; 383(5): 440-451, 2020 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-32726530

RESUMO

BACKGROUND: Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options. METHODS: We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score. RESULTS: A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group. CONCLUSIONS: Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).


Assuntos
Leiomioma/cirurgia , Qualidade de Vida , Embolização da Artéria Uterina , Miomectomia Uterina , Neoplasias Uterinas/cirurgia , Adulto , Feminino , Humanos , Histeroscopia , Análise de Intenção de Tratamento , Complicações Intraoperatórias , Laparoscopia , Leiomioma/terapia , Tempo de Internação , Menorragia , Pessoa de Meia-Idade , Reserva Ovariana , Complicações Pós-Operatórias , Reoperação/estatística & dados numéricos , Embolização da Artéria Uterina/efeitos adversos , Miomectomia Uterina/efeitos adversos , Miomectomia Uterina/métodos , Neoplasias Uterinas/terapia , Útero/cirurgia
16.
BMC Surg ; 20(1): 55, 2020 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-32192462

RESUMO

BACKGROUND: Abdominal myomectomy (AM) and laparoscopic myomectomy (LM) are commonly see surgery for the uterine fibroids, several randomized controlled trials (RCTs) have compared the role of AM and LM, the results remained inconsistent. Therefore, we attempted this meta-analysis to analyze the role of LM versus AM in patients with uterine fibroids. METHODS: We searched PubMed et al. databases from inception date to July 31, 2019 for RCTs that compared LM versus AM in patients with uterine fibroids. Two authors independently screened the studies and extracted data from the published articles. Summary odd ratios(OR) or mean differences(MD) with 95% confidence intervals(CI) were calculated for each outcome by means of fixed- or random-effects model. RESULTS: Twelve RCTs with a total of 1783 patients were identified, with 887 patients for and 897 patients for AM. Compared with AM, LM could significantly decrease the blood loss (OR = - 29.78, 95% CI -57.62- - 0.95), shorten the duration of postoperative ileus (OR = - 10.91, 95% CI -18.72- - 3.11), reduce the length of hospital stay (OR = - 1.57, 95% CI -2.05- - 1.08), but LM was associated with longer duration of operation (OR = 16.10, 95% CI 6.52-25.67) and higher medical cost (OR = 17.61, 95% CI 7.34-27.88). CONCLUSIONS: LM seems to be a better choice for patients with uterine fibroids, more related studies are needed to identify the role of LM and AM for the treatment of uterine fibroids.


Assuntos
Leiomioma/cirurgia , Miomectomia Uterina/métodos , Neoplasias Uterinas/cirurgia , Feminino , Humanos , Laparoscopia/métodos , Tempo de Internação , Complicações Pós-Operatórias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
J Manag Care Spec Pharm ; 26(1-a Suppl): S2-S10, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31958025

RESUMO

BACKGROUND: Uterine fibroids (UF) affect up to 70%-80% of women by 50 years of age and represent a substantial economic burden on patients and society. Despite the high costs associated with UF, recent studies on the costs of UF-related surgical treatments remain limited. OBJECTIVE: To describe the health care resource utilization (HCRU) and all-cause costs among women diagnosed with UF who underwent UF-related surgery. METHODS: Data from the IBM MarketScan Commercial Claims and Encounters database and Medicaid Multi-State database were independently, retrospectively analyzed from January 1, 2009, to December 31, 2015. Women aged 18-64 years with ≥ 1 UF claim from January 1, 2010, to December 31, 2014, a claim for a UF-related surgery (hysterectomy, myomectomy, uterine artery embolization [UAE], or ablation) from January 1, 2010, to November 30, 2015, and continuous enrollment for ≥ 1 year presurgery and ≥ 30 days postsurgery qualified for study inclusion. A 1-year period before the date of the first UF-related surgical claim after the first UF diagnosis was used to report baseline demographic and clinical characteristics. Surgery characteristics were reported. All-cause HCRU and costs (adjusted to 2017 U.S. dollars) were described by the 14 days pre-, peri-, and 30 days postoperative periods, and independently by the inpatient or outpatient setting. RESULTS: Overall, 113,091 patients were included in this study: commercial database, n = 103,814; Medicaid database, n = 9,277. Median time from the initial UF diagnosis to first UF-related surgical procedure was 33 days for the commercial population and 47 days for the Medicaid population. Hysterectomy was the most common UF-related surgery received after UF diagnosis (commercial, 68% [n = 70,235]; Medicaid, 75% [n = 6,928]). In both populations, 97% of patients had ≥ 1 outpatient visit from 14 days presurgery to 30 days postsurgery (commercial, n = 100,402; Medicaid, n = 9,023), and the majority of all UF-related surgeries occurred in the outpatient setting (commercial, 64% [n = 66,228]; Medicaid, 66% [n = 6,090]). Mean total all-cause costs for patients with UF who underwent any UF-related surgery were $15,813 (SD $13,804) in the commercial population (n = 95,433) and $11,493 (SD $26,724) in the Medicaid population (n = 4,785). Mean total all-cause costs for UF-related surgeries for the commercial/Medicaid populations were $17,450 (SD $13,483)/$12,273 (SD $19,637) for hysterectomy, $14,216 (SD $16,382)/$11,764 (SD $15,478) for myomectomy, $17,163 (SD $13,527)/$12,543 (SD $23,777) for UAE, $8,757 (SD $9,369)/$7,622 (SD $50,750) for ablation, and $12,281 (SD $10,080)/$5,989 (SD $5,617) for myomectomy and ablation. Mean total all-cause costs for any UF-related surgery performed in the outpatient setting in the commercial and Medicaid populations were $14,396 (SD $11,466) and $6,720 (SD $10,374), respectively, whereas costs in the inpatient setting were $18,345 (SD $16,910) and $21,805 (SD $43,244), respectively. CONCLUSIONS: This retrospective analysis indicated that surgical treatment options for UF continue to represent a substantial financial burden. This underscores the need for alternative, cost-effective treatments for the management of UF. DISCLOSURES: This study was sponsored by Allergan, Dublin, Ireland. Allergan played a role in the conduct, analysis, interpretation, writing of the report, and decision to publish this study. Harrington and Ye are employees of Allergan. Stafkey-Mailey, Fuldeore, and Yue are employees of Xcenda. Ta was a contractor at Allergan at the time the study was conducted and is currently supported by a training grant from Allergan. Bonine, Shih, and Gillard are employees of Allergan and have stock, stock options, and/or restricted stock units as employees of Allergan. Banks has no disclosures to report. This study was presented as a poster at Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.


Assuntos
Custos de Cuidados de Saúde/estatística & dados numéricos , Leiomioma/cirurgia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Técnicas de Ablação/economia , Técnicas de Ablação/estatística & dados numéricos , Adolescente , Adulto , Bases de Dados Factuais , Feminino , Humanos , Histerectomia/economia , Histerectomia/estatística & dados numéricos , Leiomioma/economia , Medicaid , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos , Embolização da Artéria Uterina/economia , Embolização da Artéria Uterina/estatística & dados numéricos , Miomectomia Uterina/economia , Miomectomia Uterina/estatística & dados numéricos , Adulto Jovem
18.
Int J Med Robot ; 16(1): e2061, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31840384

RESUMO

BACKGROUND: To introduce a hybrid robotic single-site myomectomy (H-RSSM) technique that includes laparoscopic single-site myoma excision followed by robotic single-site suture and compare its surgical outcomes with those of conventional robotic single-site myomectomy (RSSM) using the da Vinci Si surgical system. METHODS: Medical records of 89 consecutive women who underwent H-RSSM and 131 consecutive women who underwent RSSM were retrospectively reviewed. Patients characteristics and surgical outcomes were evaluated and compared between two groups. RESULTS: The H-RSSM group had a significantly reduced operation time (98.7 ± 31.7 vs 141.4 ± 54.4 min, P < .001) and lower estimated blood loss (131.5 ± 78.1 vs 212.3 ± 189.8 mL, P < .001). Peritoneal adhesions were reported significantly more in the H-RSSM group than in the RSSM group (27.0% vs 9.2%, P < .001). CONCLUSION: H-RSSM was found to be associated with reduced operative time and lower estimated blood loss. However, further prospective studies are needed to clarify these advantages.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Duração da Cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Miomectomia Uterina/métodos , Adulto , Feminino , Humanos , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/economia , Miomectomia Uterina/economia
19.
J Comp Eff Res ; 9(1): 53-65, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31840551

RESUMO

Aim: We examine the impact of the new risk information about a surgical device on surgery and patient outcomes for hysterectomy in the inpatient setting. Methods: We utilize a difference-in-differences approach to assess the impact of new risk information on patient outcomes in the inpatient setting between 2009 and 2014. The inpatient data come from a nationally representative sample of hospitalizations in the USA. We use the likelihood of laparoscopic surgery, measures of resource use and surgical complications as outcome variables. Results: We estimate a three-percentage point decrease in the likelihood of receiving laparoscopic hysterectomy, a one-percentage point increase in the likelihood of experiencing a surgical complication and no impact on resource use, relative to pre-existing means. Conclusion: Our findings show that there was movement away from laparoscopic surgery in the months following the dissemination of new risk information. These changes had limited effect on patient outcomes.


Assuntos
Histerectomia/métodos , Leiomioma/cirurgia , Morcelação/efeitos adversos , Ovariectomia/métodos , Neoplasias Uterinas/cirurgia , Feminino , Gastos em Saúde , Humanos , Histerectomia/efeitos adversos , Histerectomia/economia , Pacientes Internados , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Tempo de Internação , Pessoa de Meia-Idade , Morcelação/economia , Morcelação/instrumentação , Ovariectomia/efeitos adversos , Ovariectomia/economia , Complicações Pós-Operatórias/epidemiologia , Medição de Risco , Estados Unidos , United States Food and Drug Administration , Miomectomia Uterina/efeitos adversos , Miomectomia Uterina/métodos
20.
J Robot Surg ; 13(5): 635-642, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30919259

RESUMO

Common benign gynecologic procedures include hysterectomies and myomectomies, with hysterectomy being the most common gynecologic procedure in the United States [1]. While historically performed via laparotomy, the field of gynecologic surgery was revolutionized with the advent of laparoscopic techniques, with the most recent advancement being the introduction of robotic-assisted surgery in 2005. Robotic surgery has all the benefits of laparoscopic surgery such as decreased blood loss, quicker return to activities, and shorter length of hospital stay. Additional robotic-specific advantages include but are not limited to improved ergonomics, 3D visualization, and intuitive surgical movements. Despite these advantages, one of the most commonly cited drawbacks of robotic surgery is the associated cost. While the initial cost to purchase the robotic console and its associated maintenance costs are relatively high, robotic surgery can be cost-effective when utilized correctly.This article reviews application strategies and factors that can offset traditional costs and maximize the benefits of robotic surgery.


Assuntos
Redução de Custos , Análise Custo-Benefício , Doenças dos Genitais Femininos/economia , Doenças dos Genitais Femininos/cirurgia , Histerectomia/economia , Laparoscopia/educação , Procedimentos Cirúrgicos Robóticos/economia , Miomectomia Uterina/economia , Perda Sanguínea Cirúrgica/prevenção & controle , Feminino , Humanos , Histerectomia/métodos , Laparoscopia/métodos , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos/métodos , Miomectomia Uterina/métodos
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