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1.
BMJ ; 368: l6764, 2020 01 03.
Artículo en Inglés | MEDLINE | ID: mdl-31900245

RESUMEN

The studyCooper K, Breeman S, Scott NW, et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet 2019;394:1425-36.The study was funded by the NIHR Health Technology Assessment Programme (project number 12/35/23).To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000837/keyhole-hysterectomy-is-effective-for-women-with-heavy-menstrual-bleeding.


Asunto(s)
Técnicas de Ablación Endometrial , Laparoscopía , Menorragia/cirugía , Femenino , Humanos , Histerectomía , Evaluación de la Tecnología Biomédica
2.
Lancet ; 394(10207): 1425-1436, 2019 10 19.
Artículo en Inglés | MEDLINE | ID: mdl-31522846

RESUMEN

BACKGROUND: Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. METHODS: In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. FINDINGS: Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8-22·8; adjusted OR 1·87, 95% CI 1·31-2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56-3·02; p=0·54). INTERPRETATION: Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.


Asunto(s)
Técnicas de Ablación Endometrial , Histerectomía/métodos , Laparoscopía/métodos , Menorragia/cirugía , Adulto , Técnicas de Ablación Endometrial/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Histerectomía/efectos adversos , Análisis de Intención de Tratar , Laparoscopía/efectos adversos , Persona de Mediana Edad , Tempo Operativo , Evaluación del Resultado de la Atención al Paciente , Satisfacción del Paciente , Complicaciones Posoperatorias , Calidad de Vida , Reino Unido
4.
Int J Hyperthermia ; 36(1): 739-743, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31385549

RESUMEN

Purpose: Vascular-rich myomas are resistant to treatment involving transcervical microwave myolysis. To overcome cooling by blood perfusion, we injected dilute vasopressin solution into the space between the myometrium and the surface of the vascular-rich myomas. Material and Methods: Seven outpatients [age (mean ± SD age), 44.9 ± 3.9 years] with a single symptomatic vascular-rich submucosal myoma measuring 4.2-9.2 cm (6.5 ± 2.5 cm) underwent transcervical microwave myolysis and microwave endometrial ablation. Before microwave irradiation, dilute vasopressin solution was injected into the space between the myometrium and the surface of the vascular-rich myoma. We assessed the changes in the volumes of the vascular-rich myomas and blood hemoglobin levels before and 3 and 6 months after treatment. In addition, improvements in menorrhagia and satisfaction after the operation were assessed using visual analog scales. Results: Submyometrial injection of dilute vasopressin effectively reduced the abundant blood flow. The vascular-rich myomas were necrotized and shrank significantly by 69.0% at 3 months and 72.4% at 6 months after the operation (p < .05). Blood hemoglobin levels significantly increased at 3 months (p < .01). In addition, the visual analog scale results indicated that menorrhagia improved subjectively and the patients were satisfied with the results of the operation. Conclusions: Vasopressin injection before transcervical microwave myolysis leads to extended necrosis of vascular-rich submucosal myomas.


Asunto(s)
Técnicas de Ablación Endometrial/métodos , Leiomioma/tratamiento farmacológico , Leiomioma/cirugía , Mioma/tratamiento farmacológico , Mioma/cirugía , Neoplasias Uterinas/tratamiento farmacológico , Neoplasias Uterinas/cirugía , Vasopresinas/uso terapéutico , Adulto , Femenino , Humanos , Leiomioma/patología , Persona de Mediana Edad , Mioma/patología , Neoplasias Uterinas/patología , Vasopresinas/administración & dosificación , Vasopresinas/farmacología
5.
Cochrane Database Syst Rev ; 8: CD000329, 2019 08 29.
Artículo en Inglés | MEDLINE | ID: mdl-31463964

RESUMEN

BACKGROUND: Heavy menstrual bleeding (HMB) is an important cause of ill health in women of reproductive age, causing them physical problems, social disruption and reducing their quality of life. Medical therapy has traditionally been first-line therapy. Surgical treatment of HMB often follows failed or ineffective medical therapy. The definitive treatment is hysterectomy, but this is a major surgical procedure with significant physical and emotional complications, as well as social and economic costs. Less invasive surgical techniques, such as endometrial resection and ablation, have been developed with the purpose of improving menstrual symptoms by removing or ablating the entire thickness of the endometrium. OBJECTIVES: To compare the effectiveness, acceptability and safety of techniques of endometrial destruction by any means versus hysterectomy by any means for the treatment of heavy menstrual bleeding. SEARCH METHODS: Electronic searches for relevant randomised controlled trials (RCTs) targeted-but were not limited to-the following: the Cochrane Gynaecology and Fertility Group's specialised register, CENTRAL via the Cochrane Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO, and the ongoing trial registries. We made attempts to identify trials by examining citation lists of review articles and guidelines and by performing handsearching. Searches were performed in 1999, 2007, 2008, 2013 and on 10 December 2018. SELECTION CRITERIA: Any RCTs that compared techniques of endometrial resection or ablation (by any means) with hysterectomy (by any technique) for the treatment of heavy menstrual bleeding in premenopausal women. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data and assessed trials for risk of bias. MAIN RESULTS: We identified nine RCTs that fulfilled our inclusion criteria for this review. For two trials, the review authors identified multiple publications that assessed different outcomes at different postoperative time points for the same women. No included trials used third generation techniques.Clinical measures of improved bleeding symptoms and satisfaction rates were observed in women who had undergone hysterectomy compared to endometrial ablation. A slightly lower proportion of women who underwent endometrial ablation perceived improvement in bleeding symptoms at one year (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.85 to 0.93; 4 studies, 650 women, I² = 31%; low-quality evidence), at two years (RR 0.92, 95% CI 0.86 to 0.99; 2 studies, 292 women, I² = 53%) and at four years (RR 0.93, 95% CI 0.88 to 0.99; 2 studies, 237 women, I² = 79%). Women in the endometrial ablation group also showed improvement in pictorial blood loss assessment chart compared to their baseline (PBAC) score at one year (MD 24.40, 95% CI 16.01 to 32.79; 1 study, 68 women; moderate-quality evidence) and at two years (MD 44.00, 95% CI 36.09 to 51.91; 1 study, 68 women). Repeat surgery resulting from failure of the initial treatment was more likely to be needed after endometrial ablation than after hysterectomy at one year (RR 16.17, 95% CI 5.53 to 47.24; 927 women; 7 studies; I2 = 0%), at two years (RR 34.06, 95% CI 9.86 to 117.65; 930 women; 6 studies; I2 = 0%), at three years (RR 22.90, 95% CI 1.42 to 370.26; 172 women; 1 study) and at four years (RR 36.32, 95% CI 5.09 to 259.21;197 women; 1 study). The satisfaction rate was lower amongst those who had endometrial ablation at two years after surgery (RR 0.87, 95% CI 0.80 to 0.95; 4 studies, 567 women, I² = 0%; moderate-quality evidence), and no evidence of clear difference was reported between post-treatment satisfaction rates in groups at other follow-up times (1 and 4 years).Most adverse events, both major and minor, were more likely after hysterectomy during hospital stay. Women who had an endometrial ablation were less likely to experience sepsis (RR 0.19, 95% CI 0.12 to 0.31; participants = 621; studies = 4; I2 = 62%), blood transfusion (RR 0.20, 95% CI 0.07 to 0.59; 791 women; 5 studies; I2 = 0%), pyrexia (RR 0.17, 95% CI 0.09 to 0.35; 605 women; 3 studies; I2 = 66%), vault haematoma (RR 0.11, 95% CI 0.04 to 0.34; 858 women; 5 studies; I2 = 0%) and wound haematoma (RR 0.03, 95% CI 0.00 to 0.53; 202 women; 1 study) before hospital discharge. After discharge from hospital, the only difference that was reported for this group was a higher rate of infection (RR 0.27, 95% CI 0.13 to 0.58; 172 women; 1 study).Recovery time was shorter in the endometrial ablation group, considering hospital stay, time to return to normal activities and time to return to work; we did not, however, pool these data owing to high heterogeneity. Some outcomes (such as a woman's perception of bleeding and proportion of women requiring further surgery for HMB), generated a low GRADE score, suggesting that further research in these areas is likely to change the estimates. AUTHORS' CONCLUSIONS: Endometrial resection and ablation offers an alternative to hysterectomy as a surgical treatment for heavy menstrual bleeding. Both procedures are effective, and satisfaction rates are high. Although hysterectomy offers permanent and immediate relief from heavy menstrual bleeding, it is associated with a longer operating time and recovery period. Hysterectomy also has higher rates of postoperative complications such as sepsis, blood transfusion and haematoma (vault and wound). The initial cost of endometrial destruction is lower than that of hysterectomy but, because retreatment is often necessary, the cost difference narrows over time.


Asunto(s)
Técnicas de Ablación Endometrial/métodos , Endometrio/cirugía , Menorragia/cirugía , Femenino , Humanos , Histerectomía , Histeroscopía , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
6.
Zhejiang Da Xue Xue Bao Yi Xue Ban ; 48(2): 136-141, 2019 Apr 25.
Artículo en Chino | MEDLINE | ID: mdl-31309750

RESUMEN

OBJECTIVE: To determine the efficacy of second generation endometrial ablation (NovaSure) combined with levonorgestrel-releasing intrauterine system (Mirena) in the treatment of adenomyosis. METHODS: Clinical data of patients with adenomyosis admitted in Women's Hospital, Zhejiang University School of Medicine from January 2015 to December 2018 were retrospectively analyzed. Among 66 patients, 44 received Mirena placement only (control group) and 22 received Mirena placement and NovaSure treatment (study group). The menstruation blood loss, dysmenorrhea score, uterine size, expulsion rate of Mirena and the patients' satisfaction rate were assessed in two groups. RESULTS: There was a significant reduction in menstruation blood loss (P<0.05) and significant improvement in dysmenorrhea (P<0.05) after the treatment in both groups. The patients in study group had more marked improvement in menstruation blood loss than those in control group (P<0.05). The patients' satisfaction was higher and the expulsion rate of Mirena was lower in study group than that in control group (all P<0.05). The score of dysmenorrhea and the size of uterine had no significant difference between two groups (all P>0.05). CONCLUSIONS: NovaSure can improve the efficacy of Mirena in treatment of adenomyosis.


Asunto(s)
Adenomiosis , Técnicas de Ablación Endometrial , Levonorgestrel , Adenomiosis/terapia , Dismenorrea , Femenino , Humanos , Levonorgestrel/administración & dosificación , Tamaño de los Órganos , Estudios Retrospectivos , Útero/anatomía & histología
7.
PLoS One ; 14(7): e0219294, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31291298

RESUMEN

BACKGROUND: Abnormal uterine bleeding needs surgical treatment if medical therapy fails. After introduction of non-hysteroscopic endometrial ablation as alternative to hysteroscopic endometrial resection, we aimed to compare short and long-term outcomes for women treated with these two minimally-invasive procedures. A secondary goal was comparing the present cohort to a previous cohort of women treated with hysteroscopic resection only. MATERIALS AND METHODS: Historical cohort study of women treated for abnormal uterine bleeding with hysteroscopic resection or endometrial ablation at Haukeland University Hospital during 2006-2014. Similar patient file and patient-reported outcome data were collected from 386 hysteroscopic resections in a previous cohort (1992-1998). Categorical variables were compared by Chi-square or Fisher´s Exact-test, linear variables by Mann-Whitney U-test and time to hysterectomy by the Kaplan-Meier method. RESULTS: During 2006-2014, 772 women were treated with endometrial resection or ablation, 468 women (61%) consented to study-inclusion; 333 women (71%) were treated with hysteroscopic resection and 135 (29%) with endometrial ablation. Preoperative characteristics were significantly different for women treated with hysteroscopic resection compared to endometrial ablation in the 2006-2014-cohort and between the two time-cohorts regarding menopausal, sterilization and myoma status (p≤0.036). The endometrial ablation group had significantly shorter operation time, median 13 minutes (95% Confidence Interval (CI) 12-14) and a lower complication rate (2%) versus operation time, median 25 minutes (95% CI 23-26) and complication rate (13%) in the hysteroscopy group, all p ≤0.001. The patient-reported rate of satisfaction with treatment was equivalent in both groups (85%, p = 0.955). The endometrial ablation group had lower hysterectomy rate (8% vs 16%, p = 0.024). Patient-reported satisfaction rate was higher (85%) in the 2006-2014-cohort compared with the 1992-1998-cohort (73%), p<0.001. CONCLUSIONS: Endometrial ablation has similar patient satisfaction rate, but shorter operation time and lower complication rate and may be a good alternative to hysteroscopic resection for treatment of abnormal uterine bleeding.


Asunto(s)
Técnicas de Ablación Endometrial , Endometrio/cirugía , Histeroscopía , Metrorragia/cirugía , Adulto , Estudios de Cohortes , Endometrio/fisiopatología , Femenino , Humanos , Metrorragia/fisiopatología , Persona de Mediana Edad , Tempo Operativo , Satisfacción del Paciente , Embarazo , Resultado del Tratamiento
8.
PLoS One ; 14(6): e0217579, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31185019

RESUMEN

OBJECTIVE: The objective of the study was to compare success rates, complications and management costs of different surgical techniques for abnormal uterine bleeding (AUB). METHODS: This was a retrospective analysis of the French national hospital discharge database. All hospital stays with a diagnostic code for AUB and an appropriate surgical procedure code between 2009 and 2015 inclusive were identified, concerning 109,884 women overall. Outcomes were compared between second generation procedures (2G surgery), first-generation procedures (1G surgery), curettage and hysterectomy. Clinical outcomes were treatment failure and complications during the follow-up period. Costs were attributed using standard French hospital tariffs. RESULTS: 7,863 women underwent a 2G procedure (7.2%), 39,935 a 1G procedure, (36.3%), 38,923 curettage (35.4%) and 23,163 hysterectomy (21.1%). Failure rates at 18 months were 9.9% for 2G surgery, 12.7% for 1G surgery, 20.6% for curettage and 2.8% for hysterectomy. Complication rates at 18 months were 1.9% for 2G surgery, 1.5% for 1G surgery, 1.4% for curettage and 5.3% for hysterectomy. Median 18-month costs were € 1 173 for 2G surgery, € 1 059 for 1G surgery, € 782 for curettage and € 3 090 for hysterectomy. CONCLUSION: Curettage has the highest failure rate. Hysterectomy has the lowest failure rate but the highest complication rate and is also the most expensive. Despite good clinical outcomes and relatively low cost, 1G and 2G procedures are not widely used. Current guidelines for treatment of AUB are not respected, the recommended 2G procedures being only used in <10% of cases.


Asunto(s)
Legrado/economía , Bases de Datos Factuales , Histerectomía/economía , Alta del Paciente/economía , Hemorragia Uterina/economía , Hemorragia Uterina/cirugía , Adulto , Técnicas de Ablación Endometrial , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Hemorragia Uterina/epidemiología
9.
Medicine (Baltimore) ; 98(17): e15156, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31027059

RESUMEN

RATIONALE: In women, menorrhagia associated with aplastic anemia (AA) is secondary to thrombocytopenia and can be acute and severe. Endometrial ablation or hysterectomy has been reported to achieve beneficial results. However, serious limitations and long-term complications exist. We report this clinical case series with the aim of sharing our experiences and exploring a safe and effective way to treat abnormal uterine bleeding (AUB) AA women with future fertility desire. PATIENT CONCERNS: The 3 young patients aged 25 to 29 years old suffered from AUB secondary to AA. DIAGNOSIS: They were diagnosed with AA by bone marrow biopsy and presented with symptoms and signs of AUB without other identified causations. INTERVENTIONS: When the platelet count was between 30*10 /L∼50*10 /L after a blood transfusion, each patient received a hysteroscopic resection of endometrial functional layer and was fitted a levonorgestrel-releasing intra-uterine system (LNG-IUS) in uterine cavity following the surgery. OUTCOMES: All the patients recovered without incident and were discharged in clinically stable conditions. LESSONS: In conclusion, AUB secondary to AA can be acute and severe. Hemostasis is more difficult due to progressive pancytopenia. For young women with future fertility desire, LNG-IUS following hysteroscopic resection of endometrial functional layer is a safe and effective way against endometrial ablation or hysterectomy.


Asunto(s)
Anemia Aplásica/complicaciones , Anticonceptivos Femeninos/administración & dosificación , Técnicas de Ablación Endometrial , Levonorgestrel/administración & dosificación , Menorragia/etiología , Menorragia/terapia , Adulto , Anemia Aplásica/terapia , Endometrio/efectos de los fármacos , Endometrio/cirugía , Femenino , Humanos , Dispositivos Intrauterinos
10.
BMJ Open ; 9(2): e024260, 2019 02 19.
Artículo en Inglés | MEDLINE | ID: mdl-30782899

RESUMEN

OBJECTIVE: To examine the factors associated with receiving surgery for heavy menstrual bleeding (HMB) in England and Wales. DESIGN: National cohort study. SETTING: National Health Service hospitals. PARTICIPANTS: Women with HMB aged 18-60 who had a new referral to secondary care. METHODS: Patient-reported data linked to administrative hospital data. Risk ratios (RR) estimated using multivariable Poisson regression. PRIMARY OUTCOME MEASURE: Surgery within 1 year of first outpatient clinic visit. RESULTS: 14 545 women were included. At their first clinic visit, mean age was 42 years, mean symptom severity score was 62 (scale ranging from 0 (least) to 100 (most severe)), 73.9% of women reported having symptoms for >1 year and 30.4% reported no prior treatment in primary care. One year later, 42.6% had received surgery. Of these, 57.8% had endometrial ablation and 37.2% hysterectomy. Women with more severe symptoms were more likely to have received surgery (most vs least severe quintile, 33.1% vs 56.0%; RR 1.6, 95% CI 1.5 to 1.7). Surgery was more likely among those who reported prior primary care treatment compared with those who did not (48.0% vs 31.1%; RR 1.5, 95% CI 1.4 to 1.6). Surgery was less likely among Asian and more likely among black women, compared with white women. Surgery was not associated with socioeconomic deprivation. CONCLUSIONS: Receipt of surgery for HMB depends on symptom severity and prior treatment in primary care. Referral pathways should be locally audited to ensure women with HMB receive care that addresses their individual needs and preferences, especially for those who do not receive treatment in primary care.


Asunto(s)
Endometriosis/cirugía , Procedimientos Quirúrgicos Ginecológicos/estadística & datos numéricos , Leiomioma/cirugía , Menorragia/cirugía , Atención Primaria de Salud/estadística & datos numéricos , Neoplasias Uterinas/cirugía , Adolescente , Adulto , Grupo de Ascendencia Continental Africana/estadística & datos numéricos , Grupo de Ascendencia Continental Asiática/estadística & datos numéricos , Estudios de Cohortes , Técnicas de Ablación Endometrial/estadística & datos numéricos , Endometriosis/complicaciones , Inglaterra , Grupo de Ascendencia Continental Europea/estadística & datos numéricos , Femenino , Humanos , Histerectomía/estadística & datos numéricos , Leiomioma/complicaciones , Menorragia/etiología , Persona de Mediana Edad , Atención Secundaria de Salud , Índice de Severidad de la Enfermedad , Medicina Estatal , Embolización de la Arteria Uterina/estadística & datos numéricos , Miomectomía Uterina/estadística & datos numéricos , Neoplasias Uterinas/complicaciones , Gales , Adulto Joven
11.
J Minim Invasive Gynecol ; 26(5): 847-855, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30165183

RESUMEN

STUDY OBJECTIVE: To investigate rates of utilization of alternative treatments before hysterectomy for benign gynecologic indications within a large integrated health care system. DESIGN: Retrospective cohort study of patients who underwent hysterectomies for benign gynecologic conditions between 2012 and 2014 (Canadian Task Force classification II-2). SETTING: Kaiser Permanente Northern California, a community-based integrated health system. PATIENTS: Women who underwent hysterectomy for a benign gynecologic condition between 2012 and 2014. INTERVENTIONS: From an eligible cohort of 6892 patients who underwent hysterectomy, a stratified random sample of 1050 patients were selected for chart review. Stratification was based on the proportion of indications for hysterectomy. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the use of alternative treatments before hysterectomy. Alternative treatments included oral hormone treatment, leuprolide, medroxyprogesterone intramuscular injections, a levonorgestrel intrauterine device, hormonal subdermal implants, endometrial ablation, uterine artery embolization, hysteroscopy, and myomectomy. Of the 1050 charts reviewed, 979 (93.2%) met the criteria for inclusion in this study. The predominant indication for hysterectomy was symptomatic myomas (54.4%), followed by abnormal uterine bleeding (29.0%), endometriosis (5.8%), pelvic pain (3.1%), dysmenorrhea (3.4%), and other (4.3%). The major routes of hysterectomy were laparoscopy (68.7%) and vaginal hysterectomy (13.4%). Before hysterectomy, 81.2% of patients tried at least 1 type of alternative treatment (33.8% with 1 treatment and 47.4% with at least 2 treatments), and 99.3% of patients were counseled regarding alternative treatments. Compared with younger women age <40 years, women age 45 to 49 years were less likely to use alternative treatments before hysterectomy (adjusted odds ratio, 0.41; 95% confidence interval, 0.21-0.76). There were no variations in treatment rates by socioeconomic status or between major racial and ethnic groups. The final pathological analysis identified myomas as the most common pathology (n = 637; 65.1%); 96 patients (9.8%) had normal uterine pathology. CONCLUSION: More than 80% of patients received alternative treatments before undergoing hysterectomy for a benign gynecologic condition. Additional investigation is warranted to assess alternative treatment use as it relates to preventing unnecessary hysterectomies.


Asunto(s)
Técnicas de Ablación Endometrial/métodos , Histerectomía/métodos , Enfermedades Uterinas/cirugía , Enfermedades Uterinas/terapia , Adulto , California/epidemiología , Prestación Integrada de Atención de Salud , Endometriosis/cirugía , Femenino , Humanos , Histerectomía/estadística & datos numéricos , Histeroscopía , Laparoscopía , Levonorgestrel/uso terapéutico , Medroxiprogesterona/uso terapéutico , Persona de Mediana Edad , Mioma/cirugía , Dolor Pélvico/cirugía , Estudios Retrospectivos , Clase Social , Embolización de la Arteria Uterina/métodos , Miomectomía Uterina/métodos
12.
J Minim Invasive Gynecol ; 26(1): 105-109, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-29702269

RESUMEN

STUDY OBJECTIVES: To report 2 cases of uterine tumors resembling ovarian sex cord tumors (UTROSCTs) and examine the clinical significance of these tumors found during hysteroscopic endometrial ablation despite benign preoperative endometrial biopsy analysis and imaging suggestive of leiomyoma. DESIGN: Case report (Canadian Task Force classification III). SETTING: Tertiary care hospital. PATIENTS: Two patients with abnormal uterine bleeding. INTERVENTIONS: Hysteroscopic endometrial ablation/resection. MEASUREMENTS AND MAIN RESULTS: Pathological analysis of intrauterine tissue/lesions obtained by curettage or resection identified 2 unexpected UTROSCTs masquerading as leiomyomas. Following hysterectomy, no residual UTROSCT was identified in the specimens, and both women are well, one at 1 year postsurgery and the other at 3 years postsurgery. CONCLUSION: Obtaining additional tissue by routine curettage before endometrial ablation and/or endomyometrial resection, in conjunction with removal of any intrauterine lesions, can identify rare unexpected endometrial lesions not sampled by endometrial biopsy, not detected with ultrasound, and masquerading as leiomyomas during endometrial ablation.


Asunto(s)
Técnicas de Ablación Endometrial , Histeroscopía , Tumores de los Cordones Sexuales y Estroma de las Gónadas/patología , Neoplasias Uterinas/patología , Endometrio/patología , Femenino , Humanos , Histerectomía , Leiomioma/patología , Leiomioma/cirugía , Menorragia/diagnóstico , Menorragia/etiología , Persona de Mediana Edad , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/patología , Patología Clínica , Tumores de los Cordones Sexuales y Estroma de las Gónadas/diagnóstico , Tumores de los Cordones Sexuales y Estroma de las Gónadas/cirugía , Neoplasias Uterinas/diagnóstico , Neoplasias Uterinas/cirugía
13.
J Minim Invasive Gynecol ; 26(1): 71-77, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-29609032

RESUMEN

STUDY OBJECTIVE: To compare surgical excision and ablation of endometriosis for treatment of chronic pelvic pain. DESIGN: Randomized clinical trial with 12-month follow-up (Canadian Task Force classification I). SETTING: Single academic tertiary care hospital. PATIENTS: Women with minimal to mild endometriosis undergoing laparoscopy. INTERVENTIONS: Excision or ablation of superficial endometriosis at the time of robot-assisted laparoscopy. MEASUREMENTS AND MAIN RESULTS: Primary outcome was visual analog scale (VAS) scoring at baseline and 6 and 12 months for menstrual pain, nonmenstrual pain, dyspareunia, and dyschezia. Secondary outcomes included survey results at baseline and 6 and 12 months from the Short Form Health Survey, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, and the International Pelvic Pain Assessment. From December 2013 to October 2014, 73 patients were randomized intraoperatively to excision (n = 37) or ablation (n = 36) of endometriosis. Patients were followed at 6 and 12 months to evaluate the above outcomes. After ablation of endometriosis, dyspareunia (VAS scores) improved at 6 months (mean change [MC], -14.07; 95% confidence interval [CI], -25.93 to -2.21; p = .02), but improvement was not maintained at 12 months. Dysmenorrhea improved at 6 months (MC, -26.99; 95% CI, -41.48 to -12.50; p < .001) and 12 months (MC, -24.15; 95% CI, 39.62 to -8.68; p = .003) with ablation. No significant changes were seen in VAS scores after excision at 6 or 12 months. When comparing ablation and excision, the only significant difference was a change in dyspareunia at 6 months (MC, -22.96; 95% CI, -39.06 to -6.86; p = .01). CONCLUSION: Treatment with ablation improved dysmenorrhea at 6 and 12 months and improved dyspareunia at 6 months as compared with preoperative data. However, only dyspareunia demonstrated a significant difference between ablation and excision. Excision and ablation showed similar effectiveness for the treatment of pain associated with superficial endometriosis, with ablation showing more significant individual changes. Careful patient counseling regarding expectations of surgical intervention is vital in the management of endometriosis.


Asunto(s)
Técnicas de Ablación Endometrial , Endometriosis/cirugía , Dolor Pélvico/cirugía , Adulto , Dolor Crónico/cirugía , Dismenorrea/etiología , Dismenorrea/cirugía , Dispareunia/etiología , Dispareunia/cirugía , Endometriosis/complicaciones , Femenino , Humanos , Laparoscopía/métodos , Dimensión del Dolor , Dolor Pélvico/etiología , Encuestas y Cuestionarios , Adulto Joven
14.
J Minim Invasive Gynecol ; 26(4): 679-687, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30036631

RESUMEN

STUDY OBJECTIVE: To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB). DESIGN: A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1). SETTING: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. PATIENTS: One hundred fifty-five premenopausal women aged 30 to 50years with HMB as determined by a pictorial blood loss assessment score ≥150. Preoperative evaluation included ultrasound, sonohysterography or hysteroscopy, and endometrial biopsy. Screening inclusion allowed treatment of up to 12-cm uterine sound lengths and nonobstructing myomata. INTERVENTIONS: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. MEASUREMENTS AND MAIN RESULTS: The primary effectiveness end point was the reduction of menstrual blood loss to a pictorial blood loss assessment score ≤75. Success was judged based on the Food and Drug Administration's objective performance criteria, derived from the success rates of the first 5 global endometrial ablation pivotal clinical trials. The secondary effectiveness end points included quality of life and patient satisfaction as assessed using the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score as well as the need for surgical or medical intervention to treat abnormal bleeding at any time within the first 12 months after treatment. All adverse events, including device- and procedure-related events, were recorded. At 12 months, the primary effectiveness end point was achieved in 78.7% of subjects exceeding the OPC (p = .0004); 90.8% of subjects were satisfied or very satisfied with the treatment. Ninety-nine percent of subjects showed improvement in quality of life scores with an average decrease in the Menorrhagia Impact Questionnaire score by 8.1, 72% had less dysmenorrhea, and 85% of women whose sex lives were affected by their menses reported improvement in their sex lives. There were no reported serious adverse device effects or any reported serious adverse events that were procedure related. CONCLUSION: The AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from HMB.


Asunto(s)
Técnicas de Ablación Endometrial/instrumentación , Menorragia/cirugía , Adulto , Dismenorrea , Técnicas de Ablación Endometrial/estadística & datos numéricos , Endometrio/cirugía , Femenino , Humanos , Histeroscopía , Persona de Mediana Edad , Satisfacción del Paciente/estadística & datos numéricos , Embarazo , Premenopausia , Estudios Prospectivos , Calidad de Vida
15.
Conf Proc IEEE Eng Med Biol Soc ; 2018: 3236-3239, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-30441081

RESUMEN

Thermal ablation of the endometrial lining of the uterus is a minimally-invasive technique for treatment of menorrhagia. We have previously presented a 915 MHz microwave triangular loop antenna for endometrial ablation. Uterine fibroids are benign pelvic tumors, of considerably different water content compared to normal uterus, and may change the shape of the uterus. Collectively, these changes introduced by fibroids may alter the pattern of microwave endometrial ablation. In this study, we have investigated the effect of 1 - 3 cm diameter uterine fibroids in different locations around the uterine cavity on ablation profiles following 60 W, 150 s microwave exposure with a loop antenna. Our computational model predicts ablation zone extents within 1 ± 0.8 of ablation zones observed in experiments in ex vivo tissue. The maximum change in simulated ablation depths due to the presence of fibroids was 1.1 mm. In summary, this simulation study suggests that 1 - 3 cm diameter uterine fibroids can be expected to have minimal impact on the extent of microwave endometrial ablation patterns.


Asunto(s)
Ablación por Catéter , Técnicas de Ablación Endometrial , Leiomioma , Menorragia , Endometrio , Femenino , Humanos , Leiomioma/cirugía , Microondas
16.
J Comp Eff Res ; 7(12): 1209-1218, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30451534

RESUMEN

AIMS: To compare durability of uterus-conserving procedures for symptomatic fibroids in terms of incidence and time to subsequent procedures. PATIENTS & METHODS: We conducted a retrospective database study of 2648 patients having a uterus-conserving procedure for uterine fibroids from 2005 to 2011 with a minimum of 2 years follow-up. RESULTS: Patients with myomectomy or uterine artery embolization as their index procedure had lower risk of a subsequent procedure during the study compared with patients who underwent endometrial ablation. CONCLUSION: While subject to known limitations of using electronic medical record and administrative claims data, this research provides additional evidence regarding expectations for time to subsequent procedures that may be helpful for women and their healthcare providers to consider when making treatment choices.


Asunto(s)
Reclamos Administrativos en el Cuidado de la Salud/estadística & datos numéricos , Investigación sobre la Eficacia Comparativa/métodos , Leiomioma/terapia , Registro Médico Coordinado , Neoplasias Uterinas/terapia , Adulto , Bases de Datos Factuales , Técnicas de Ablación Endometrial , Femenino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Embolización de la Arteria Uterina , Miomectomía Uterina , Adulto Joven
17.
Menopause ; 25(12): 1476-1478, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30234731

RESUMEN

: In clinical practice, although only 3% to 7% of women with postmenopausal bleeding (PMB) will ultimately be found to have cancer, it is the clinician's responsibility to ensure that endometrial cancer is not present. The diagnostic evaluation of PMB has evolved greatly. This Practice Pearl addresses the appropriate evaluation of women with PMB.


Asunto(s)
Neoplasias Endometriales/diagnóstico , Endometrio/diagnóstico por imagen , Endometrio/patología , Posmenopausia , Hemorragia Uterina/diagnóstico , Biopsia , Técnicas de Ablación Endometrial/efectos adversos , Femenino , Humanos , Histeroscopía , Factores de Riesgo , Ultrasonografía
18.
Surg Technol Int ; 33: 161-177, 2018 Nov 11.
Artículo en Inglés | MEDLINE | ID: mdl-30117138

RESUMEN

Endometrial ablation (EA) is the most commonly performed surgical procedure for the management of abnormal uterine bleeding unresponsive to medical therapy. In well-selected subjects, EA provides a safe, inexpensive, and convenient alternative to hysterectomy with a rapid return to normal function. The first generation of EA techniques were introduced in 1886 by Professor Sneguireff of Moscow. He was the first to apply super-heated steam to the uterine cavity to vaporize the endometrial basalis. This method-known as atmocausis-was refined by Ludwig Pincus of Danzig in 1895, and he went on to perform over 800 procedures. As the 20th century brought forth other energy sources-electricity, X-ray, radium, and even cryogenics-they were each used, in turn, to accomplish endometrial ablation. In 1981, Dr. Milton Goldrath successfully performed EA by co-locating a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser with a rod-lens hysteroscope to achieve photovaporization of the endometrium. The accomplishment of EA under direct visualization defined the second generation of EA. The challenges and risks of second-generation technology, however, was soon apparent, and though this practice continues today, it appears to be confined to a relatively small number of devoted and highly-skilled sub-specialists. The late 1990s saw increasing interest in safe, affordable, and easily-mastered EA technology. The result was a return to blind technology but modified with a variety of features that brought unprecedented safety to EA, even permitting its selected in-office application. This third generation of EA techniques and devices has propelled the growth of EA in the 21st century. Although much has been accomplished in the quest for safe, affordable, convenient, and easily-mastered EA, the future requires refinement of patient selection criteria, management strategies for late-onset endometrial ablation failures (LOEAFs), as well as minimally invasive methods for reducing them.


Asunto(s)
Técnicas de Ablación Endometrial , Técnicas de Ablación Endometrial/instrumentación , Técnicas de Ablación Endometrial/métodos , Técnicas de Ablación Endometrial/tendencias , Endometrio/cirugía , Diseño de Equipo , Femenino , Humanos
19.
J Womens Health (Larchmt) ; 27(10): 1204-1214, 2018 10.
Artículo en Inglés | MEDLINE | ID: mdl-30085898

RESUMEN

BACKGROUND: Women with uterine fibroids (UF) may undergo less invasive procedures than hysterectomy, including myomectomy, endometrial ablation (EA), and uterine artery embolization (UAE); however, long-term need for reintervention is not well characterized. We estimated reintervention rates for 5 years and identified predictors of reintervention. MATERIALS AND METHODS: A longitudinal retrospective cohort study was conducted in women in MarketScan® Commercial Claims and Encounters (Truven Health Analytics) aged 18-49 years with UF diagnosis before myomectomy, EA, or UAE from 2008 to 2014. Patients were categorized by initial procedure (index date) and required to have ≥12 months of continuous coverage before and after. Kaplan-Meier analyses and Cox proportional hazard models were used to estimate survival without reintervention and hazard of reintervention for 5 years. RESULTS: The study included 35,631 women with myomectomy (n = 13,804: 8,018 abdominal, 941 hysteroscopic, and 4,845 laparoscopic), EA (n = 17,198), and UAE (n = 4,629). Myomectomy had the lowest 12-month reintervention rate (4.2%), followed by UAE (7.0%), then EA (12.4%; both p < 0.001 relative of myomectomy). Estimates of 5-year reintervention rates were 19% for myomectomy (17%, 28%, and 20% for abdominal, hysteroscopic, and laparoscopic, respectively), 33% for EA, and 24% for UAE. EA and UAE had adjusted hazard ratios of 2.63 (95% confidence interval [CI], 2.44-2.83) and 1.56 (95% CI, 1.42-1.72). Prior anemia, bleeding, pelvic inflammatory disease, and abdominal and pelvic pain increased the hazard of reintervention. CONCLUSION: Reintervention rate estimates ranged from 17% to 33% for 5 years after myomectomy, EA, and UAE for patients with UF. Risk of requiring reintervention should be considered during treatment selection.


Asunto(s)
Técnicas de Ablación Endometrial/efectos adversos , Leiomioma/cirugía , Complicaciones Posoperatorias , Reoperación/estadística & datos numéricos , Embolización de la Arteria Uterina/efectos adversos , Miomectomía Uterina/efectos adversos , Neoplasias Uterinas/cirugía , Adulto , Técnicas de Ablación Endometrial/métodos , Técnicas de Ablación Endometrial/estadística & datos numéricos , Femenino , Humanos , Leiomioma/epidemiología , Leiomioma/patología , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Estados Unidos/epidemiología , Embolización de la Arteria Uterina/métodos , Embolización de la Arteria Uterina/estadística & datos numéricos , Miomectomía Uterina/métodos , Miomectomía Uterina/estadística & datos numéricos , Neoplasias Uterinas/epidemiología , Neoplasias Uterinas/patología
20.
J Obstet Gynaecol Res ; 44(9): 1787-1792, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-29998482

RESUMEN

AIM: Menorrhagia and dysmenorrhea are common symptoms. Uterine adenomyosis is one of the causes of menorrhagia and dysmenorrhea. These symptoms often decrease the quality of life in women. Microwave endometrial ablation (MEA) is a recently developed procedure that enables endometrial ablation. Dienogest has long been used to suppress endometrium development and reduce adenomyosis-related dysmenorrhea. However, some cases could be resistant to dienogest. In this study, we evaluated the efficacy of a combination of MEA and postoperative dienogest in reducing adenomyosis-related dysmenorrhea and menorrhagia. METHODS: Ten patients with hormone treatment-resistant symptomatic adenomyosis underwent MEA and were administered oral dienogest after the procedure. The primary endpoints were reduction in pain recurrence and anemia. The secondary endpoint was a change in the adenomyosis lesion and its symptomatic recurrence. RESULTS: Statistically significant improvements were seen in the visual analog scale score and hemoglobin levels in women post-treatment. The difference in myometrial thickness pre- and post-MEA was statistically significant. There were no cases of symptomatic recurrence. CONCLUSION: The combination of MEA and postoperative dienogest is useful for treating uterine adenomyosis with menorrhagia and dysmenorrhea.


Asunto(s)
Adenomiosis , Dismenorrea , Técnicas de Ablación Endometrial/métodos , Antagonistas de Hormonas/farmacología , Menorragia , Microondas/uso terapéutico , Nandrolona/análogos & derivados , Adenomiosis/complicaciones , Adenomiosis/tratamiento farmacológico , Adenomiosis/cirugía , Adulto , Terapia Combinada , Dismenorrea/tratamiento farmacológico , Dismenorrea/etiología , Dismenorrea/cirugía , Femenino , Antagonistas de Hormonas/administración & dosificación , Humanos , Menorragia/tratamiento farmacológico , Menorragia/etiología , Menorragia/cirugía , Persona de Mediana Edad , Nandrolona/administración & dosificación , Nandrolona/farmacología , Estudios Retrospectivos
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