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BACKGROUND: Robotic-assisted laparoscopic surgery (RALS) has become a widely and increasingly used modality of minimally invasive surgery in the treatment of endometrial cancer (EC). Due to its technical advantages, RALS offers benefits, such as a lower rate of conversions compared to conventional laparoscopy (CLS). Yet, data on long-term oncological outcomes after RALS is scarce and based on retrospective cohort studies only. OBJECTIVES: This study aimed to assess overall survival (OS), progression-free survival (PFS), and long-term surgical complications in EC patients randomly assigned to RALS or CLS. STUDY DESIGN: This randomized controlled trial was conducted at the Department of Gynecology and Obstetrics of Tampere University Hospital, Finland. Between 2010 and 2013, 101 patients with low-grade EC scheduled for minimally invasive surgery were randomized preoperatively 1:1 either to RALS or CLS. All patients underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy. A total of 97 patients (49 in the RALS group and 48 in the CLS group) were followed up for a minimum of 10 years. Survival was analyzed using Kaplan-Meier curves, log-rank test, and Cox proportional hazard models. Binary logistic regression analysis was used to analyze risk factors for trocar site hernia. RESULTS: In the multivariable regression analysis, OS was favorable in the RALS group (HR 0.39; 95% CI, 0.15-0.99, p=.047) compared to the CLS group. There was no difference in PFS (log-rank test, p=.598). The three-, 5- and 10-year OS were 98.0% (95% CI, 94.0-100) vs. 97.9% (93.8-100), 91.8% (84.2-99.4) vs. 93.7% (86.8-100), and 75.5% (64.5-87.5) vs. 85.4% (75.4-95.4) in the CLS and the RALS group, respectively. Trocar site hernia developed more often in the RALS group compared to the CLS group 18.2% vs. 4.1% (OR 5.42, 95% CI, 1.11-26.59, p=.028). The incidence of lymphocele, lymphedema, or other long-term complications did not differ between the groups. CONCLUSIONS: The results of this RCT suggest a minor OS benefit in EC after RALS compared to CLS. Hence, the use of RALS in the treatment of EC seems safe, but larger RCTs are needed to confirm the potential survival benefit of RALS. No alarming safety signals were detected in the RALS group since the rate of long-term complications differed only in the incidence of trocar site hernia.
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PURPOSE: Hysterectomy may be a risk factor for pelvic organ prolapse (POP). We assessed the risk of recurrent POP (operations and visits) after hysterectomy among women with previous POP. We also studied patient and operation related risk factors for POP recurrence. METHODS: This retrospective cohort study included 1697 women having previous POP diagnosis or POP at the time of hysterectomy (FINHYST 2006 cohort). Follow-up was until the end of 2016. The data was derived from the Finnish National Care register linked to the cohort. Hysterectomy approaches and other demographics were compared to the risk of a prolapse diagnosis and/or surgery. Cox regression model was used to identify hazard ratios. RESULTS: Following hysterectomy, a total of 280 women (16.5%) had a POP reoperation and 359 (21.2%) had an outpatient visit due to POP. Vaginal vault prolapse repair was the most common POP reoperation (n = 181, 10.7%), followed by anterior wall repair (n = 120, 7.1%). Median time to POP reoperation was 3.7 years. Hysterectomy approach did not affect reoperations or visits. Previous cesarean section and anterior repair during hysterectomy were associated with decreased risk, whereas concomitant sacrospinous fixation and uterus prolapse as the main indication led to increased risk of anterior/vault prolapse reoperations. Concomitant posterior repair decreased posterior reoperations and visits, but uterus weight over 500 g caused a fivefold increased risk of posterior prolapse visit. Residential status was associated with elevated risk of any POP reoperations and visits. CONCLUSIONS: Approximately one out of five women suffering from POP ensue POP reoperation or visit after hysterectomy. These high rates are independent on hysterectomy approach, but probably indicate that hysterectomy may worsen previous pelvic floor dysfunction.
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INTRODUCTION: Hysterectomy may have an effect on the pelvic floor. Here, we evaluated the rates and risks for pelvic organ prolapse (POP) surgeries and visits among women with a history of hysterectomy for benign indication excluding POP. MATERIAL AND METHODS: In this retrospective cohort study 3582 women who underwent hysterectomy in 2006 were followed until the end of 2016. The cohort was linked to the Finnish Care Register to catch any prolapse-related diagnoses and operation codes following the hysterectomy. Different hysterectomy approaches were compared according to the risk for a prolapse, including abdominal, laparoscopic, laparoscopic-assisted vaginal and vaginal. The main outcomes were POP surgery and outpatient visit for POP, and Cox regression was used to identify risk factors (hazard ratios [HR]). RESULTS: During the follow-up, 58 women (1.6%) underwent a POP operation, of which a posterior repair was the most common (n = 39, 1.1%). Outpatient visits for POP symptoms occurred in 92 (2.6%) women of which posterior wall prolapses (n = 58, 1.6%) were the most common. History of laparoscopic-assisted vaginal hysterectomy were associated with risk for POP operation (HR 3.0, p = 0.02), vaginal vault prolapse operation (HR 4.3, p = 0.01) and POP visits (HR 2.2, p < 0.01) as compared to the approach of abdominal hysterectomy. History of vaginal deliveries and concomitant stress urinary continence operation were associated with the risk for a POP operation (HR 4.4 and 11.9) and POP visits (HR 3.9 and 7.2). CONCLUSIONS: Risk for POP operations and outpatient visits for POP symptoms in hysterectomized women without a preceding POP seems to be small at least 10 years after hysterectomy. History of LAVH, vaginal deliveries and concomitant stress urinary incontinence operations increased the risk for POP operations after hysterectomy. These data can be utilized in counseling women considering hysterectomy for benign indication.
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Histerectomia , Prolapso de Órgão Pélvico , Feminino , Humanos , Masculino , Seguimentos , Estudos Retrospectivos , Histerectomia/efeitos adversos , Histerectomia Vaginal , Prolapso de Órgão Pélvico/cirurgia , Prolapso de Órgão Pélvico/etiologiaRESUMO
INTRODUCTION: Hysterectomy has been one of the most common surgical procedures in women in Finland. We studied the population-based trends of hysterectomy and its indications from 1986 to 2017. MATERIAL AND METHODS: A retrospective population-based cohort was created from the Care Register for Health Care by identifying women who had a hysterectomy from 1986 to 2017 and calculating the number of women from the Digital and Population Data Services Agency. We estimated the number and incidence of hysterectomy by period and age as well as by indication. We considered the primary diagnosis at the time of surgery as the indication of hysterectomy. RESULTS: The number of hysterectomies increased from 7492 procedures in 1986 to 12 404 procedures in 1998, and reduced substantially after that to 5971 procedures in 2017, the turning point being in 1999. The incidence rate of hysterectomy has decreased on average by 2.5% annually from 432.6 per 100 000 women in 1998-2001 to 224.5 per 100 000 women in 2014-2017. The median age at the time of hysterectomy has increased from 51 years in 1998-2001 to 55 years in 2014-2017. The cumulative burden of hysterectomy by age of 60 years has nearly halved from the first 4-year period (23%) to the last (12%). After 2010, the most common indication has been genital prolapse and incontinence, whereas earlier it was uterine fibroids. CONCLUSIONS: The number and incidence of hysterectomies have fluctuated during the observation period 1986-2017 and decreased considerably during the past 17 years in Finland. This is probably a result of the availability of hormonal and other conservative treatment options for bleeding disorders and uterine fibroids. As hysterectomy practically removes the risk for endometrial cancer, the change in hysterectomy incidence over time emphasizes the importance of correcting endometrial cancer incidence according to hysterectomy incidence.
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Histerectomia/tendências , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Finlândia/epidemiologia , Doenças dos Genitais Femininos/epidemiologia , Doenças dos Genitais Femininos/cirurgia , Humanos , Incidência , Leiomioma/epidemiologia , Leiomioma/cirurgia , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Neoplasias Uterinas/epidemiologia , Neoplasias Uterinas/cirurgia , Adulto JovemRESUMO
OBJECTIVE: To evaluate the relationship between cesarean scar defect and abnormal uterine bleeding at one year after cesarean section (CS). STUDY DESIGN: A prospective observational cohort study was conducted in 401 women who delivered by CS between January 2016 and January 2017. Women were screened for isthmocele with sonohysterography six months after CS and followed by electronic questionnaires at 12, 13 and 14 months after CS. The main outcome measure was the prevalence of postmenstrual spotting. Secondary outcome measures were the duration of menstrual bleeding, prevalence of postcoital bleeding, dyspareunia or dysmenorrhea, usage of painkillers, and absence from work or other activities. RESULTS: The response rate was 88 %. In the isthmocele group, the prevalence of postmenstrual spotting was 20.0 % compared to 8.3 % in women without isthmocele (OR 2.75 [95 % CI 1.39-5.44]; Pâ¯=â¯0.004). Additionally, women with isthmocele reported more frequently postcoital bleeding (8.3 % vs. 2.4 %; OR 3.73 [95 % CI 1.18-11.83]; Pâ¯=â¯0.026). The prevalence of postmenstrual spotting was even higher in the subgroup of large isthmoceles, (25.9 % vs. 9.5 %; (OR 3.34 [95 % CI 1.72-6.49]; Pâ¯<â¯0.001). CONCLUSION: The prevalence of postmenstrual spotting among isthmocele patients was 20.0 %. Additionally, postmenstrual spotting was associated with the presence of isthmocele inquired at 1â¯year after CS.
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Cesárea/efeitos adversos , Cicatriz/complicações , Hemorragia Uterina/etiologia , Adulto , Feminino , Finlândia/epidemiologia , Humanos , Prevalência , Estudos Prospectivos , Hemorragia Uterina/epidemiologiaRESUMO
BACKGROUND: Cesarean scar defect (isthmocele) is a known complication after cesarean delivery. It has become more common due to a rising cesarean delivery rate. Isthmocele has been associated with various gynecological and obstetric problems such as uterine rupture, cesarean scar pregnancy, and bleeding disorders. OBJECTIVE: We sought to prospectively investigate factors associated with the risk for isthmocele assessed by sonohysterography. STUDY DESIGN: A prospective observational cohort study was conducted in 401 nonpregnant women who were recruited within 3 days of cesarean delivery. Women were evaluated with sonohysterography 6 months after cesarean delivery to detect a possible isthmocele. The ultrasonographer was blinded to any clinical information. The main outcome measure was the presence of isthmocele. Type of surgery (elective vs emergency), maternal background variables, and factors related to pregnancy, labor, and postoperative recovery were analyzed in relation to isthmocele. A logistic regression model was used to assess independent risk factors from univariate analysis. RESULTS: In all, 371 women were examined with sonohysterography resulting in a follow-up rate of 92.5%. The prevalence of isthmocele was 45.6%. Independent risk factors for isthmocele development were a history of gestational diabetes (odds ratio, 1.73; 95% confidence interval, 1.02-2.92; P = .042), previous cesarean delivery (odds ratio, 3.14; 95% confidence interval, 1.90-5.17; P < .001), and advanced maternal body mass index (odds ratio, 1.06; 95% confidence interval, 1.01-1.11; P = .012). Every additional unit of body mass index increased the risk of isthmocele by 6%. In the subgroup of emergency cesarean delivery, longer duration of active labor increased the risk for isthmocele (odds ratio, 1.06; 95% confidence interval, 1.01-1.11; P = .032). There was no statistically significant difference in prevalence between the groups of elective and emergency cesarean delivery (P = .898). CONCLUSION: Based on sonohysterographic examination, maternal body mass index, gestational diabetes, and previous cesarean deliveries are associated with an increased risk for incomplete healing of the uterine incision.
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Cesárea/efeitos adversos , Cicatriz/etiologia , Adulto , Índice de Massa Corporal , Cicatriz/diagnóstico por imagem , Cicatriz/epidemiologia , Estudos de Coortes , Diabetes Gestacional , Tratamento de Emergência , Feminino , Idade Gestacional , Humanos , Gravidez , Estudos Prospectivos , Fatores de Risco , UltrassonografiaRESUMO
INTRODUCTION: The aim of this study was to investigate the prevalence of post-cesarean isthmocele and to measure agreement between transvaginal ultrasonography and saline contrast sonohysterography in assessment of isthmocele. MATERIAL AND METHODS: A prospective observational cohort study was carried out at Tampere University Hospital, Finland. Non-pregnant women delivered by cesarean section (n = 371) were examined with transvaginal ultrasonography (TVUS) and sonohysterography (SHG) six months after cesarean section. The main outcome measure was the prevalence of isthmocele using TVUS and SHG. Secondary outcome measures were characteristics of isthmocele. RESULTS: In all, 371 women were included. The prevalence of isthmocele was 22.4% based on TVUS and 45.6% based on SHG. Sensitivity and specificity for TVUS was 49.1 and 100%, respectively, when compared with SHG. Therefore, half of the defects (50.9%) diagnosed with SHG remained undiagnosed with TVUS. Bland-Altman analysis showed an underestimation of 1.1 mm (range 0.00-7.90) for TVUS compared with SHG, with 95% limits of agreement from -1.9 to 4.1 mm. CONCLUSIONS: This methodological study provides confirmatory data that TVUS and SHG are not in good agreement in the isthmocele diagnostics and the use of only TVUS may lead to an underestimation of the prevalence of isthmocele. Thus, SHG should be considered as a method of choice in diagnostics of isthmocele.
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Cesárea , Cicatriz/diagnóstico por imagem , Ultrassonografia/métodos , Útero/diagnóstico por imagem , Adulto , Cicatriz/patologia , Meios de Contraste , Feminino , Finlândia , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Cloreto de Sódio , Útero/patologiaRESUMO
OBJECTIVE: Mini-invasive surgery has essentially replaced open laparotomy in surgery for endometrial and cervical carcinoma. Of the procedures needed for a complete staging, especially para-aortic lymphadenectomy (PALND) is challenging to perform. The present study was undertaken to investigate the technical and surgical outcomes of robotic-assisted PALND for gynecological cancers in the setting of a tertiary university hospital in Finland. METHODS: This was a retrospective chart review of 283 robotic-assisted para-aortic lymphadenectomies using the single-docking transperitoneal technique performed at the Department of Obstetrics and Gynecology of Tampere University Hospital, in 2009-2016. The primary outcome measure was the extent of the operation in terms of the height, that is, how often the level cranial to the inferior mesenteric artery (IMA) was achieved. The secondary outcome measures included operation time and surgical outcome. RESULTS: The majority of operations (n = 239 [84.4%]) were performed for endometrial carcinoma. The most common operation type was robotic-assisted hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy and PALND, which took a median of 3:38 hours or 218 minutes (range, 140-341 minutes) to perform. The high PALND (above the level of IMA) succeeded in 235 operations (83%). In the total cohort, the median number of para-aortic lymph nodes removed was 12 (range, 0-38), with a learning curve approximately more than 40 operations. Para-aortic lymph node metastases were found in 43 patients (15.2%). Seven conversions to laparotomy (2.5%) were done. The conversion and intraoperative complication rates were 2.5% and 3.5%, respectively, and postoperative complications was 18%, according to the classification of Clavien-Dindo. The median length of the postoperative hospital stay was 2 days (range, 1-8 days). CONCLUSIONS: Using the transperitoneal technique for PALND, the area between IMA and the renal veins can be reached in more than 80% of the operations, with a very low or 2.5% conversion rate.
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Carcinoma/cirurgia , Neoplasias do Endométrio/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Excisão de Linfonodo/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Procedimentos Cirúrgicos em Ginecologia/estatística & dados numéricos , Humanos , Excisão de Linfonodo/estatística & dados numéricos , Pessoa de Meia-Idade , Pelve/cirurgia , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Adulto JovemRESUMO
OBJECTIVES: The purpose of this study was to compare the costs of traditional laparoscopy and robotic-assisted laparoscopy in the treatment of endometrial cancer. METHODS AND MATERIALS: A total of 101 patients with endometrial cancer were randomized to the study and operated on starting from 2010 until 2013, at the Department of Obstetrics and Gynecology of Tampere University Hospital, Tampere, Finland. Costs were calculated based on internal accounting, hospital database, and purchase prices and were compared using intention-to-treat analysis. Main outcome measures were item costs and total costs related to the operation, including a 6-month postoperative follow-up. RESULTS: The total costs including late complications were 2160 &OV0556; higher in the robotic group (median for traditional 5823 &OV0556;, vs robot median 7983 &OV0556;, P < 0.001). The difference was due to higher costs for instruments and equipment as well as to more expensive operating room and postanesthesia care unit time. Traditional laparoscopy involved higher costs for operation personnel, general costs, medication used in the operation, and surgeon, although these costs were not substantial. There was no significant difference in in-patient stay, laboratory, radiology, blood products, or costs related to complications. CONCLUSIONS: According to this study, robotic-assisted laparoscopy is 37% more expensive than traditional laparoscopy in the treatment of endometrial cancer. The cost difference is mainly explained by amortization of the robot and its instrumentation.
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Neoplasias do Endométrio/economia , Neoplasias do Endométrio/cirurgia , Procedimentos Cirúrgicos em Ginecologia/economia , Laparoscopia/economia , União Europeia , Feminino , Finlândia , Procedimentos Cirúrgicos em Ginecologia/métodos , Custos de Cuidados de Saúde , Humanos , Laparoscopia/métodosRESUMO
BACKGROUND: Previous studies comparing robotic-assisted laparoscopic surgery to traditional laparoscopic or open surgery in gynecologic oncology have been retrospective. To our knowledge, no prospective randomized trials have thus far been performed on endometrial cancer. OBJECTIVE: We sought to prospectively compare traditional and robotic-assisted laparoscopic surgery for endometrial cancer. STUDY DESIGN: This was a randomized controlled trial. From December 2010 through October 2013, 101 endometrial cancer patients were randomized to hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy either by robotic-assisted laparoscopic surgery or by traditional laparoscopy. The primary outcome measure was overall operation time. The secondary outcome measures included total time spent in the operating room, and surgical outcome (number of lymph nodes harvested, complications, and recovery). The study was powered to show at least a 25% difference in the operation time using 2-sided significance level of .05. The differences between the traditional laparoscopy and the robotic surgery groups were tested by Pearson χ2 test, Fisher exact test, or Mann-Whitney test. RESULTS: In all, 99 patients were eligible for analysis. The median operation time in the traditional laparoscopy group (n = 49) was 170 (range 126-259) minutes and in the robotic surgery group (n = 50) was 139 (range 86-197) minutes, respectively (P < .001). The total time spent in the operating room was shorter in the robotic surgery group (228 vs 197 minutes, P < .001). In the traditional laparoscopy group, there were 5 conversions to laparotomy vs none in the robotic surgery group (P = .027). There were no differences as to the number of lymph nodes removed, bleeding, or the length of postoperative hospital stay. Four (8%) vs no (0%) patients (P = .056) had intraoperative complications and 5 (10%) vs 11 (22%) (P = .111) had major postoperative complications in the traditional and robotic surgery groups, respectively. CONCLUSION: In patients with endometrial cancer, robotic-assisted laparoscopic surgery was faster to perform than traditional laparoscopy. Also total time spent in the operation room was shorter in the robotic surgery group and all conversions to laparotomy occurred in the traditional laparoscopy group. Otherwise, the surgical outcome was similar between the groups. Robotic surgery offers an effective and safe alternative in the surgical treatment of endometrial cancer.
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Neoplasias do Endométrio/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimiorradioterapia Adjuvante , Quimioterapia Adjuvante , Conversão para Cirurgia Aberta/estatística & dados numéricos , Neoplasias do Endométrio/patologia , Feminino , Humanos , Histerectomia/métodos , Laparoscopia/métodos , Excisão de Linfonodo/métodos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Duração da Cirurgia , Ovariectomia/métodos , Pelve , Complicações Pós-Operatórias/epidemiologia , Radioterapia Adjuvante , Salpingectomia/métodosRESUMO
OBJECTIVES: The aim of this follow-up study was to explore the long-term effects of a 6-month trial of exercise training on hot flushes. The follow-up was 4 years after the exercise intervention ended. STUDY DESIGN: A cohort study after a randomised controlled trial. Ninety-five of the 159 randomised women (60%) participated in anthropometric measurements and performed a 2-km walk test. Participants completed a questionnaire and kept a one-week diary on physical activity, menopause symptoms and sleep quality. The frequency of 24-h hot flushes was multiplied by severity and the total sum for one week was defined as the Hot Flush Score (HFScore). Multilevel mixed regression models were analysed to compare the exercise and control groups. MAIN OUTCOME MEASURE: Hot Flush Score (HFScore) as assessed with the one-week symptom diary. RESULTS: The women in the exercise group had a higher probability of improved HFScore, i.e. a decrease in HFScore points, adjusted for hormone therapy (OR 0.95; 95% CI 0.90-1.00) than women in the control group at the 4-year follow-up. After additional adjustment for sleep quality, the result approached statistical significance at HFScore≥13 with women in the exercise group. Women who had the least amount of hot flushes, HFScore<13, benefited most from exercise during the 4-year follow-up when compared with women in the control group. CONCLUSIONS: Women in the exercise group had positive effects on their HFScore 4 years after a 6-month exercise intervention.
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Terapia por Exercício/métodos , Fogachos/terapia , Menopausa/fisiologia , Envelhecimento , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Sono/fisiologia , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of the study was to explore the long-term effects of physical activity intervention on quality of life (QoL) 4â years after an original randomised controlled trial (RCT). DESIGN: Cohort study after an RCT. SETTING: 95 of the 159 women from the original RCT participated in weight, height and waist circumference measurements, performed the UKK 2â km Walk Test and completed the SF-36 Health Survey questionnaire. Multilevel mixed regression models were performed in order to compare the original and current group in an RCT setting. PARTICIPANTS: There were 159 participants in the original RCT; 2.5â years later, 102 of the women responded to a questionnaire and 4-year after the trial, there were 95 respondents. The inclusion criteria in the original RCT were: being symptomatic, experiencing daily hot flushes, age between 40 and 63â years, not using hormone therapy now or in the past 3â months, sedentary lifestyle and having last menstruated 3-36â months earlier. MAIN OUTCOME MEASURE: Health-related QoL as measured with the SF-36 instrument. RESULTS: Women in the intervention group had a significantly higher probability of improved physical functioning (OR 1.41; 95% CI 1.00 to 1.99) as compared with women in the control group. In addition, women in the intervention group had higher odds of good role functioning (OR 1.21; 95% CI 0.88 to 1.67), physical health (OR 1.33; 95% CI 0.96 to 1.84) and general health (OR 1.14; 95% CI 0.81 to 1.62), relative to women in the control group, although the differences did not reach statistical significance. CONCLUSIONS: Women in the intervention group showed positive long-term effects on physical and mental dimensions of QoL after 4â years. TRIAL REGISTRATION NUMBER: ISRCTN54690027.
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Exercício Físico/psicologia , Menopausa/psicologia , Qualidade de Vida/psicologia , Exercício Físico/fisiologia , Feminino , Seguimentos , Conhecimentos, Atitudes e Prática em Saúde , Inquéritos Epidemiológicos , Humanos , Menopausa/fisiologia , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de TempoRESUMO
Menopause is a period that may predispose one to a decrease in muscle strength, cardiorespiratory fitness, and quality of life. A study was carried out to evaluate the cost-effectiveness of physical activity among women displaying symptoms of menopause. The cost-effectiveness analysis was based on data from a six-month randomised controlled trial (n = 151). The women in the intervention group engaged in an unsupervised session of at least 50 minutes of physical activity four times a week. The control group continued their physical activity as before. An incremental cost-effectiveness ratio (ICER) was calculated in terms of maximal oxygen consumption, lean muscle mass, and quality-adjusted life years (QALYs) gained. A bootstrap technique was utilised to estimate uncertainty around the point estimate for ICER associated with the intervention. The mean total cost in the intervention group was 1,307 (SEM: 311) and in the control group was 1,253 (SEM: 279, p = 0.10) per person. The mean intervention cost was 208 per person. After six months of the behaviour-change intervention, the ICER was 63 for a 1 ml/kg/min improvement in cardiorespiratory fitness, the additional cost per one-gram increase in lean muscle mass was 126, and the cost per QALY gained was 46. According to the findings, physical activity among menopausal women was cost-effective for cardiorespiratory fitness, for lean muscle mass, and for QALYs gained, since the intervention was more effective than the actions within the control group and the additional effects of physical activity were gained at a very low price. From the societal perspective, the intervention used may promote ability to work and thereby save on further costs associated with early retirement or disability pension if the physical-activity level remains at least the same as during the intervention.
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Análise Custo-Benefício , Menopausa/fisiologia , Atividade Motora , Qualidade de Vida , Estudos de Casos e Controles , Feminino , Humanos , Pessoa de Meia-Idade , Músculo Esquelético/fisiologia , Consumo de Oxigênio/fisiologia , Anos de Vida Ajustados por Qualidade de VidaRESUMO
OBJECTIVE: To assess trends for hysterectomy methods in the Nordic countries and to compare outcomes of hysterectomies in Finland done by trainees with those done by specialists. DESIGN: Register-based study. SETTING: NOMESCO database for the Nordic countries and the Finnish Hospital Discharge Register. POPULATION: National prospective cohort of 5279 hysterectomies in Finland. METHODS: Numbers of hysterectomies in the Nordic countries were collected in 1995-2011 and in Finland in 1990-2012. The Finhyst study to collect data on hysterectomies for benign indications was carried out in Finland in 2006. Information concerning patients, surgeons, and hysterectomy outcome was analysed. MAIN OUTCOME MEASURES: Hysterectomy numbers and methods. Operating time, blood loss, and complications in hysterectomies done by trainees and specialists. RESULTS: In Finland, the rate of hysterectomies has been reduced by approximately 50% since the 1990s and is now similar to that in the other Nordic countries. The laparoscopic method is twice as common in Finland as in other Nordic countries, constituting 35-40% of all hysterectomies. The operating time for all hysterectomy methods was 16-25% longer among trainees than specialists. For the abdominal or laparoscopic methods there were no significant differences in the complication rates between the groups. In the vaginal approach, blood loss of ≥1000 mL was slightly more common in operations done by trainees (1.3% vs. 2.6%, p = 0.037). CONCLUSIONS: Laparoscopic hysterectomy is more common in Finland than in the other Nordic countries. Although trainees need more time to operate, there were no differences between the trainees and the specialists with regard to major complication rates.
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Histerectomia/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Feminino , Finlândia/epidemiologia , Ginecologia/educação , Humanos , Internato e Residência/estatística & dados numéricos , Laparoscopia/estatística & dados numéricos , Pessoa de Meia-Idade , Duração da Cirurgia , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Sistema de Registros , Adulto JovemRESUMO
OBJECTIVE: To investigate the initial experience with robotic-assisted laparoscopic surgery in gynecologic oncology. DESIGN: A retrospective survey. SETTING: Tertiary referral center. POPULATION: The first 300 patients operated on using robotic assistance at the Department of Obstetrics and Gynecology of Tampere University Hospital, from March 2009 through January 2013. METHODS: Retrospective patient chart review. MAIN OUTCOME MEASURES: The primary outcome measure was the learning curve events, and the complication and conversion rates were secondary outcome measures. RESULTS: The commonest type of operation was hysterectomy, bilateral salpingoophorectomy and pelvic lymphadenectomy (LH + BSO + PLND, n = 89), followed by the same procedure amended by para-aortic lymphadenectomy (PALND, n = 74), type II radical hysterectomy (n = 24), and PLND + PALND ± omentectomy (n = 15). A learning curve was most evident for LH + BSO + PLND: whereas the median operative time of all 89 operations was 167 min (range 403-104), it was 260 (range 403-135) and 153 (range 247-104) min in the case of the first and last 20 operations, respectively. The learning curve was short, or 10 procedures. A learning curve was also seen for the preoperative time in the operation room and for the number of lymph nodes harvested. The median blood loss during all 300 operations was 100 mL (range 5-3200). The median postoperative hospital stay was 1 day. The conversion rate was 4.0%, and the complication rate 19.3% (major in 9%). CONCLUSION: The learning curve of robotic-assisted laparoscopic surgery appears to be short, or 10 operations. Robotic-assisted procedures seem to offer a safe and useful alternative to traditional techniques.
Assuntos
Carcinoma/cirurgia , Neoplasias dos Genitais Femininos/cirurgia , Procedimentos Cirúrgicos em Ginecologia , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Adulto , Idoso , Idoso de 80 Anos ou mais , Conversão para Cirurgia Aberta/estatística & dados numéricos , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/estatística & dados numéricos , Humanos , Curva de Aprendizado , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Centros de Atenção Terciária , Adulto JovemRESUMO
BACKGROUND: Physical exercise during leisure time is known to increase physical capacity; however, the long-term effects on work ability and work strain are inconclusive. The aim of this study was to investigate the effects of a 6-month physical exercise program on work ability and work strain after 6 months and 30 months, among women with menopausal symptoms at baseline. METHODS: A questionnaire including questions on work ability and work strain was mailed in the beginning, at 6 months and after 30 months after the intervention to occupationally active women participating in a randomized controlled study on physical exercise and quality of life. The intervention included aerobic exercise training 4 times per week, 50 minutes per session. Work ability was measured with the Work Ability Index (WAI) and with questions about physical and mental work strain. RESULTS: Women aged 47-62 years (N = 89) who were occupationally active at baseline were included in the analyses. The increase in WAI from baseline to the end of the exercise intervention (6 months) was statistically significantly greater among the intervention group than among the control group (regression coefficient 2.08; 95% confidence interval 0.71-3.46). The difference between the groups persisted for 30 months. No significant short- or long-term effects on physical and mental work strain were found. CONCLUSION: A 6-month physical exercise intervention among symptomatic menopausal women had positive short-term as well as long-term effects on work ability.
RESUMO
The purpose of our study was to find out whether transurethral injections of autologous adipose stem cells (ASCs) are an effective and a safe treatment for female stress urinary incontinence (SUI). We treated five SUI patients with ASCs combined with bovine collagen gel and saline. Prior to the treatment, the ASCs were isolated from subcutaneous fat and expanded for 3 weeks in a good manufacturing practice-level laboratory. The mixture of ASCs and collagen was injected transurethrally via cystoscope. Additionally, viability, multipotency, and surface marker profile of ASCs were analyzed in vitro. We followed up with patients 3, 6, and 12 months after the injections. The primary endpoint was a cough test to measure objectively the effect of the treatment. Validated questionnaires were used to determine the subjective cure rate. After 6 months, 1 of 5 patients displayed a negative cough test with full bladder filled with 500 ml of saline. At 1 year, the cough test was negative with three patients; two of them were satisfied with the treatment and did not wish further treatment for SUI. Validated questionnaires showed some subjective improvement in all five patients. This is the first study describing the use of autologous ASCs in combination with collagen gel for female SUI treatments. Thus far, the treatment with autologous ASCs has proven safe and well tolerated. However, the feasibility and efficacy of the treatment were not optimal; therefore, additional research is needed to develop SUI injection therapies.
Assuntos
Regeneração , Medicina Regenerativa/métodos , Transplante de Células-Tronco , Gordura Subcutânea/citologia , Engenharia Tecidual/métodos , Uretra/fisiopatologia , Incontinência Urinária por Estresse/cirurgia , Idoso de 80 Anos ou mais , Biomarcadores/metabolismo , Separação Celular , Sobrevivência Celular , Células Cultivadas , Colágeno , Técnicas de Diagnóstico Urológico , Feminino , Sobrevivência de Enxerto , Humanos , Pessoa de Meia-Idade , Projetos Piloto , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Alicerces Teciduais , Transplante Autólogo , Resultado do Tratamento , Uretra/metabolismo , Uretra/patologia , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária por Estresse/fisiopatologia , UrodinâmicaRESUMO
BACKGROUND: Menopause related symptoms modify quality of life and may also have an impact on work ability. OBJECTIVE: The aim of this study was to investigate the effects of physical exercise on work ability and daily strain among women with menopausal symptoms. METHODS: Occupationally active symptomatic menopausal women (n=123) were randomized into 24-week aerobic exercise intervention and control groups. Mobile phone questionnaires were used to collect daily data on perceived physical and mental strain in a randomised and controlled setting. Work ability was measured with the Work Ability Index (WAI) and with questions about work strain. PARTICIPANTS: In all 123 women aged 44-62 (mean age 53.8 ± 3.4) years who worked full- or part-time participated in the study. Women were randomized into a control (n=60) and intervention group (n=63). The subjects were mostly working in mentally demanding jobs (e.g., office worker), but also in physical (e.g., cleaner) and mixed (physical and mental) jobs (e.g., nurse). RESULTS: The increase in mental resources and decrease in physical strain from baseline to end were statistically significantly greater among the intervention group than among the control group. Between-group differences in the change in WAI were, however, statistically non-significant. CONCLUSION: A 6-month physical exercise intervention among symptomatic menopausal women seems not to be enough to increase perceived work ability but the physical exercise may increase perceived mental resources and decrease perceived daily physical strain.}
Assuntos
Exercício Físico/fisiologia , Menopausa/fisiologia , Esforço Físico , Estresse Psicológico/psicologia , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Avaliação da Capacidade de Trabalho , Local de Trabalho/psicologiaRESUMO
OBJECTIVES: To study the outcome of various hysterectomies in 2 years 1996 (N =10110) and 2006 (N=5279). The hypothesis was that the change in operative practices in 10 years has resulted in improvements. DESIGN: 2 prospective nationwide cohort evaluations with the same questionnaire. SETTING: All national operative hospitals in Finland. PARTICIPANTS: Patients scheduled to either abdominal hysterectomy (AH), vaginal hysterectomy (VH) or laparoscopic hysterectomy (LH) for benign disease. OUTCOME MEASURES: Patients' characteristics, surgery-related details and complications (organ injury, infection, venous thromboembolism and haemorrhage). RESULTS: The overall complication rates fell in LH and markedly in VH (from 22.2% to 11.7%, p<0.001). The overall surgery-related infectious morbidity decreased in all groups and significantly in VH (from 12.3% to 5.2%, p<0.001) and AH (from 9.9% to 7.7%, p<0.05). The incidence of bowel lesions in VH sank from 0.5% to 0.1% and of ureter lesions in LH from 1.1% to 0.3%. In 2006 there were no deaths compared with three in 1996. CONCLUSIONS: The rate of postoperative complications fell markedly in the decade from 1996 to 2006. This parallels with the recommendation of the recent meta-analyses by Cochrane collaboration; the order of preference of hysterectomies was for the first time precisely followed in this nationwide study. TRIAL REGISTRATION: The 2006 study was registered in the Clinical Trials of Protocol Registration System Data (NCT00744172).
RESUMO
OBJECTIVE: Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. STUDY DESIGN: A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. RESULTS: A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. CONCLUSION: Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective.