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1.
BMJ Open ; 14(5): e065966, 2024 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-38806429

RESUMO

OBJECTIVE: First-generation and second-generation endometrial ablation (EA) techniques, along with medical treatment and invasive surgery, are considered successful lines of management for abnormal uterine bleeding (AUB). We set out to determine the efficacy of first and second-generation ablation techniques compared with medical treatment, invasive surgery and different modalities of the EA techniques themselves. DESIGN: Systematic review and network meta-analysis using a frequentist network. DATA SOURCES: We searched Medline (Ovid), PubMed, ClinicalTrials.gov, Cochrane CENTRAL, Web of Science, EBSCO and Scopus for all published studies up to 1 March 2021 using relevant keywords. ELIGIBILITY CRITERIA: We included all randomised controlled trials (RCTs) that compared premenopausal women with AUB receiving the intervention of second-generation EA techniques. DATA EXTRACTION AND SYNTHESIS: 49 high-quality RCTs with 8038 women were included. We extracted and pooled the data and then analysed to estimate the network meta-analysis models within a frequentist framework. We used the random-effects model of the netmeta package in R (V.3.6.1) and the 'Meta-Insight' website. RESULTS: Our network meta-analysis showed many varying results according to specific outcomes. The uterine balloon ablation had significantly higher amenorrhoea rates than other techniques in both short (hydrothermal ablation (risk ratio (RR)=0.51, 95% CI 0.37; 0.72), microwave ablation (RR=0.43, 95% CI 0.31; 0.59), first-generation techniques (RR=0.44, 95% CI 0.33; 0.59), endometrial laser intrauterine therapy (RR=0.18, 95% CI 0.10; 0.32) and bipolar radio frequency treatments (RR=0.22, 95% CI 0.15; 0.31)) and long-term follow-up (microwave ablation (RR=0.11, 95% CI 0.01; 0.86), bipolar radio frequency ablation (RR=0.12, 95% CI 0.02; 0.90), first generation (RR=0.12, 95% CI 0.02; 0.90) and endometrial laser intrauterine thermal therapy (RR=0.04, 95% CI 0.01; 0.36)). When calculating efficacy based only on calculated bleeding scores, the highest scores were achieved by cryoablation systems (p-score=0.98). CONCLUSION: Most second-generation EA systems were superior to first-generation systems, and statistical superiority between devices depended on which characteristic was measured (secondary amenorrhoea rate, treatment of AUB, patient satisfaction or treatment of dysmenorrhoea). Although our study was limited by a paucity of data comparing large numbers of devices, we conclude that there is no evidence at this time that any one of the examined second-generation systems is clearly superior to all others.


Assuntos
Técnicas de Ablação Endometrial , Metanálise em Rede , Humanos , Feminino , Técnicas de Ablação Endometrial/métodos , Hemorragia Uterina/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
J Ultrasound Med ; 43(6): 1081-1085, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38385632

RESUMO

OBJECTIVE: To describe the ultrasonographic appearance of the post-ablative endometrium to improve knowledge of its sonographic findings. METHODS: This was an Institutional Review Board approved prospective study of patients who underwent second-generation endometrial ablation from 2016 to 2019 at a single health system. Patients had postoperative transvaginal ultrasounds at 2, 6, and 12 months. Ultrasound reports were analyzed for endometrial thickness, description of the endometrium and myometrium, presence of uterine fibroids, and uterine size. Statistical tests for repeated measures were utilized. RESULTS: There were 68 patients with the average age of 42 (SD 6) years and a BMI of 33 (SD 8). Preoperatively the average endometrial thickness was 10 mm, uterine length was 9.7 cm, and 38.2% had leiomyoma. The average endometrial thickness decreased at each ultrasound: 8.4 mm (SD 3.4), 7.2 mm (SD 3.0), and 5.8 mm (SD 2.5) at 2, 6, and 12 months, respectively. When comparing endometrial thickness postoperatively there was a significant difference at 2 and 12 months (P = .041), and 6 and 12 months (P = .031). There was no change during the postoperative period in the presence of leiomyoma, hyperechoic endometrium, hypoechoic endometrium, heterogeneous endometrium, and cystic endometrium on the ultrasounds. CONCLUSION: After ablation with a second-generation device, the endometrial thickness on ultrasound decreases with time following surgery. Additional studies correlating these findings to clinical outcomes would be useful.


Assuntos
Endométrio , Ablação por Radiofrequência , Ultrassonografia , Humanos , Feminino , Adulto , Endométrio/diagnóstico por imagem , Endométrio/cirurgia , Estudos Prospectivos , Ultrassonografia/métodos , Ablação por Radiofrequência/métodos , Leiomioma/cirurgia , Leiomioma/diagnóstico por imagem , Pessoa de Meia-Idade , Técnicas de Ablação Endometrial/métodos , Neoplasias Uterinas/cirurgia , Neoplasias Uterinas/diagnóstico por imagem
4.
Am J Obstet Gynecol ; 230(5): 542.e1-542.e10, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38280433

RESUMO

BACKGROUND: The symptom of heavy menstrual bleeding has a substantial impact on professional, physical, and social functioning. In 2021, results from a randomized controlled trial comparing a 52-mg levonorgestrel-releasing intrauterine system and radiofrequency nonresectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during 2-year follow-up. However, long-term results are also relevant for both patients and healthcare providers. OBJECTIVE: This study aimed to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52-mg levonorgestrel-releasing intrauterine system or radiofrequency nonresectoscopic endometrial ablation. STUDY DESIGN: This study was a long-term follow-up study of a multicenter randomized controlled trial (MIRA trial), in which women were allocated to either a 52-mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency nonresectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out 6 questionnaires. The primary outcome was the reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function, and patient satisfaction. RESULTS: From the 270 women who were randomized in the original trial, 196 (52-mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency nonresectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range, 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52-mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency nonresectoscopic endometrial ablation group (relative risk, 1.39; 95% confidence interval, 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher among patients with a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system compared with radiofrequency nonresectoscopic endometrial ablation (35.3% [30/85] vs 19.1% [18/94]; relative risk, 1.84; 95% confidence interval, 1.11-3.10). However, the hysterectomy rate was similar (11.8% [10/94] in the 52-mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency nonresectoscopic endometrial ablation group; relative risk, 0.65; 95% confidence interval, 0.32-1.34). Most reinterventions occurred during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function, and patient satisfaction. CONCLUSION: The overall risk of reintervention after long-term follow-up was not different between women treated according to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system and those treated using a strategy starting with radiofrequency nonresectoscopic endometrial ablation. However, women allocated to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system had a higher risk of surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies were effective in lowering menstrual blood loss over the long term. The results of this long-term follow-up study can support physicians in optimizing the counseling of women with heavy menstrual bleeding, thus promoting informed decision-making regarding choice of treatment.


Assuntos
Técnicas de Ablação Endometrial , Dispositivos Intrauterinos Medicados , Levanogestrel , Menorragia , Humanos , Feminino , Levanogestrel/administração & dosagem , Levanogestrel/uso terapêutico , Menorragia/cirurgia , Técnicas de Ablação Endometrial/métodos , Adulto , Seguimentos , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Reoperação/estatística & dados numéricos , Resultado do Tratamento
8.
Haemophilia ; 29(6): 1573-1579, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37758646

RESUMO

BACKGROUND: The International Society on Thrombosis and Haemostasis bleeding assessment tool (ISTH-BAT), is used during the diagnostic workup of bleeding disorders. Data on ISTH-BAT scores in women with heavy menstrual bleeding (HMB) undergoing endometrial ablation (EA) could be essential in optimizing HMB counselling. OBJECTIVE: To investigate the postsurgical incidence of amenorrhea, dysmenorrhea, quality of life, re-intervention after EA, and ISTH-BAT score. METHODS: This study included women who have undergone EA because of HMB. During a follow-up of 2 to 5 years, ISTH-BAT, pictorial blood assessment chart (PBAC), and Short Form-36 survey (SF-36) were administered. At 10 years of follow-up surgical re-interventions were evaluated. RESULTS: Seventy-one women were included of whom 77% (n = 55) had an ISTH-BAT score < 6, versus 23% (n = 16) ISTH-BAT score ≥6 (mean age 46.3 versus 42.3, p = 0.004). In the ISTH-BAT ≥6 group versus < 6 group, amenorrhea occurred in 63% (10/16) versus 82% (45/55) (p = 0.111), dysmenorrhea in 38% (6/16) versus 18% (10/55) (p = 0.111), and surgical re-intervention in 19% (3/16) versus 25% (14/55) (p = 0.582). SF-36 item (Bodily) pain was lower in the ISTH-BAT ≥6 group versus < 6 (median score 58.7 vs. 80.0, p = 0.104). CONCLUSIONS: An ISTH-BAT score ≥6 may be related to a lower amenorrhea incidence and higher dysmenorrhea rate after EA.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Trombose , Feminino , Humanos , Pessoa de Meia-Idade , Menorragia/cirurgia , Dismenorreia/cirurgia , Amenorreia , Qualidade de Vida , Hemorragia , Hemostasia
9.
J Minim Invasive Gynecol ; 30(11): 905-911, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37451502

RESUMO

STUDY OBJECTIVE: The purpose of this study was to better elucidate radiofrequency endometrial ablation (REA) durability by assessing the probability of failure as defined by need for postablation hysterectomy. Age at index REA, duration from REA until hysterectomy, and REA failure (REAF) risk factors were analyzed. DESIGN: A retrospective cohort study was conducted using patient data between April 1, 2002, and March 31, 2019. REAF cases were identified using operative procedure codes. Cox proportional hazard regression assessed the effect of age at index REA on time to postablation hysterectomy. Kaplan-Meier survival curve evaluated timing of postablation hysterectomy, stratified by age at index REA. SETTING: This study was conducted at Regina General Hospital in Regina, Saskatchewan, Canada. PATIENTS: Patient population included those who were 21 years of age or older, were premenopausal, and had a history of heavy menstrual bleeding at the time of REA. INTERVENTIONS: The intervention under investigation was REA. MEASUREMENTS AND MAIN RESULTS: The overall probability of postablation hysterectomy was 22.6%. The probabilities of postablation hysterectomy were 36.1% for women younger than 30 years (n = 128), 28% for women 30 to 34.9 years old (n = 528), 29.6% for women 35 to 39.9 years old (n = 1152), and 17.6% for women 40 years and older (n = 2221). Characteristics associated with REAF included tubal occlusion, cesarean section, dysmenorrhea, and chronic pelvic pain (p <.01) among women younger than 40 years. Leiomyomas accounted for higher failure rates in women 40 years and older (p <.01). CONCLUSION: Postablation hysterectomy is more likely to occur in women younger than 40 years. REA can be considered in women aged 30 to 39.9 years old, who have no known REAF risk factors. Women younger than 40 years with REAF risk factors will experience higher rates of hysterectomy. Thus, the decision to proceed with REA should be individualized with careful consideration for the underlying causes of abnormal uterine bleeding, while respecting patient autonomy.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Gravidez , Humanos , Feminino , Adulto Jovem , Adulto , Técnicas de Ablação Endometrial/efeitos adversos , Técnicas de Ablação Endometrial/métodos , Estudos Retrospectivos , Cesárea , Canadá , Menorragia/etiologia , Menorragia/cirurgia , Menorragia/epidemiologia
10.
Obstet Gynecol ; 142(1): 51-60, 2023 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-37290114

RESUMO

OBJECTIVE: To assess the risk of hysterectomy after nonresectoscopic endometrial ablation in patients with heavy menstrual bleeding. DATA SOURCES: The EMBASE, MEDLINE, ClinicalTrials.gov and Cochrane databases were searched for eligible articles from inception until June 13, 2022. We used combinations of search terms for endometrial ablation and hysterectomy. METHODS OF STUDY SELECTION: Articles included in the review described the incidence of hysterectomy at a specific point in time after ablation with a minimum follow-up duration of 12 months. TABULATION, INTEGRATION, AND RESULTS: The literature search yielded a total of 3,022 hits. A total of 53 studies met our inclusion and exclusion criteria, including six retrospective studies, 24 randomized controlled trials, and 23 prospective studies. A total of 48,071 patients underwent endometrial ablation between 1992 and 2017. Follow-up duration varied between 12 and 120 months. Analyses per follow-up moment showed 4.3% hysterectomy rate at 12 months of follow-up (n=29 studies), 11.1% at 18 months (n=1 study), 8.0% at 24 months (n=11 studies), 10.2% at 36 months (n=12 studies), 7.6% at 48 months (n=2 studies), and 12.4% at 60 months (n=6 studies). Two studies reported a mean hysterectomy rate at 10 years after ablation of 21.3%. Minimal clinically relevant differences in hysterectomy rates were observed among the different study designs. Furthermore, we found no significant differences in hysterectomy rate among the different nonresectoscopic endometrial ablation devices. CONCLUSION: The risk of hysterectomy after endometrial ablation seems to increase from 4.3% after 1 year to 12.4% after 5 years. Clinicians can use the results of this review to counsel patients about the 12% risk of hysterectomy 5 years after endometrial ablation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020156281.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Feminino , Humanos , Técnicas de Ablação Endometrial/métodos , Estudos Prospectivos , Estudos Retrospectivos , Histerectomia , Menorragia/cirurgia
11.
Artigo em Inglês | MEDLINE | ID: mdl-37279629

RESUMO

Obesity is a growing public health concern and is associated with a range of menstrual disorders, including heavy menstrual bleeding, oligomenorrhea, dysmenorrhea, and endometrial pathology. Investigations may be more logistically challenging in those in the population with obesity, and because of the heightened risk of endometrial malignancy, there should be a low threshold for biopsy to exclude endometrial hyperplasia. Although treatment modalities for women with obesity are broadly similar to those with a normal BMI, additional consideration must be given to the risks associated with estrogen in obesity. Outpatient management of heavy menstrual bleeding is a developing field and outpatient treatment modalities are preferable in the population with obesity to avoid the morbidity associated with anesthetics.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Feminino , Humanos , Menorragia/etiologia , Menorragia/terapia , Histerectomia , Distúrbios Menstruais/etiologia , Distúrbios Menstruais/terapia , Obesidade/complicações , Obesidade/epidemiologia , Obesidade/terapia
12.
J Minim Invasive Gynecol ; 30(4): 290-299, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36563871

RESUMO

STUDY OBJECTIVE: To evaluate the effectiveness and safety of ultrasound-guided percutaneous microwave ablation (MWA) for a single uterine fibroid greater than 300 cm3. DESIGN: Retrospective observational study. SETTING: China-Japan Union Hospital of Jilin University, China. PATIENTS: Thirty-seven patients each with a single fibroid greater than 300 cm3 diagnosed by ultrasound and core needle biopsy. INTERVENTIONS: Ultrasound-guided percutaneous MWA. MEASUREMENTS AND MAIN RESULTS: All patients were followed up for 12 months postoperatively to assess the postoperative lesion volume reduction rate, degree of symptomatic relief, improvements in quality of life, and occurrence of adverse events. All 37 patients met the criteria for complete ablation, and the lesion volume significantly decreased from 334.28 cm3 (95% confidence interval [CI] 326.75-366.73) preoperatively to 52.01 cm3 (95% CI, 46.95-74.69) at the 12-month follow-up (difference: 280.15 cm3; 95% CI, 267.92-294.65; p <.001). The lesion volume reduction rates at 1, 3, 6, and 12 months postoperatively were 27.30% (95% CI, 24.12-31.45), 52.90% (95% CI, 47.95-55.80), 67.90% (95% CI, 63.03-70.77), and 84.00% (95% CI, 80.22-85.94), respectively. The differences in the preoperative and postoperative Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire scores were significant (p <.01). The hemoglobin levels of the anemic patients were significantly elevated after the procedure (p <.001). Of the 37 patients in this study, 29 patients (78.38%) had a highly significant treatment effect, and 8 patients (21.62%) had a significant treatment effect. Seventeen patients (45.95%) had Society of Interventional Radiology grade A to B adverse effects that required no clinical intervention or only simple clinical intervention. CONCLUSION: Ultrasound-guided percutaneous MWA has good clinical efficacy and high safety in the treatment of a single uterine fibroid greater than 300 cm3.


Assuntos
Técnicas de Ablação Endometrial , Ablação por Ultrassom Focalizado de Alta Intensidade , Leiomioma , Neoplasias Uterinas , Feminino , Humanos , Ablação por Ultrassom Focalizado de Alta Intensidade/métodos , Leiomioma/diagnóstico por imagem , Leiomioma/cirurgia , Leiomioma/patologia , Micro-Ondas/uso terapêutico , Qualidade de Vida , Resultado do Tratamento , Ultrassonografia de Intervenção , Neoplasias Uterinas/diagnóstico por imagem , Neoplasias Uterinas/cirurgia , Neoplasias Uterinas/patologia , Estudos Retrospectivos
13.
Minerva Obstet Gynecol ; 75(3): 279-287, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35912462

RESUMO

Menorrhagia is a frequent gynecological problem that is clinically described as excessive blood loss of 80 mL per menstrual cycle. It has the potential to lower their quality of life and to induce anemia. Medical therapy has typically been the first line of treatment; however, it is frequently ineffectual. Hysterectomy, on the other hand, is clearly 100 percent effective in stopping bleeding, but it is more expensive and can cause serious problems. So, the endometrial ablation is preferred when the endometrial layer is destroyed or removed during the procedure. To "ablate" (remove) the endometrial lining, a variety of procedures has been devised. The gold standard resectoscopic procedures (laser, transcervical endometrial resection, and rollerball) require hysteroscopic visualization of the uterus and while safe, necessitate expert surgeons. Several innovative procedures have lately been developed, the majority of which may be conducted blindly and take less time. Many nonresectoscopic procedures are still in the process of being developed, refined, and investigated. This article discusses the various techniques and procedures used in endometrial ablation, the importance of the physician using endometrial thinning agents because success rates are higher when thinning agents are used, and the importance of women understanding the complications mainly related to pregnancy. Women should be helped to make informed management decisions by discussing the risks and benefits of each treatment with their consultant. Since there are many treatment options available, with no one option being superior in all respects, patient preference and treatment preferences should be considered when deciding on management.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Feminino , Humanos , Técnicas de Ablação Endometrial/métodos , Menorragia/cirurgia , Qualidade de Vida , Endométrio/cirurgia , Histerectomia
14.
Int J Gynecol Cancer ; 32(12): 1555-1560, 2022 12 05.
Artigo em Inglês | MEDLINE | ID: mdl-36375895

RESUMO

OBJECTIVE: To investigate whether a previously performed endometrial ablation is associated with the development and diagnosis of endometrial cancer. METHODS: First, a systematic review was performed of the articles reporting the incidence of endometrial cancer in patients treated with endometrial ablation. Second, a systematic review was performed to identify all individual cases of endometrial cancer after ablation to evaluate presenting symptoms, diagnostic work-up, potential risk factors, and the type and stage of the endometrial cancer. A systematic search was performed, using Medline, EMBASE, and the Cochrane Library databases, from inception through February 24, 2022. RESULTS: Based on 11 included studies, the incidence of endometrial cancer in a population of 29 102 patients with a prior endometrial ablation ranged from 0.0% to 1.6%.A total of 38 cases of endometrial cancer after ablation were identified. In 71% of cases (17 of 24 cases), vaginal bleeding was the first presenting symptom. With transvaginal ultrasound it was possible to identify and measure the endometrial thickness in eight cases. Endometrium sampling was successful in 16 of 18 described cases (89%). In 18 of 20 cases (90%) pathologic examination showed early-stage endometrioid adenocarcinoma (International Federation of Gynecology and Obstetrics stage I). CONCLUSION: Previous endometrial ablation is not associated with the development of endometrial cancer. Diagnostic work-up is not impeded by previous endometrial ablation. In addition, endometrial cancers after endometrial ablation are not detected at an advanced stage.


Assuntos
Técnicas de Ablação Endometrial , Neoplasias do Endométrio , Menorragia , Feminino , Humanos , Técnicas de Ablação Endometrial/efeitos adversos , Menorragia/patologia , Menorragia/cirurgia , Neoplasias do Endométrio/patologia , Endométrio/cirurgia , Endométrio/patologia , Hemorragia Uterina
15.
J Obstet Gynaecol Can ; 44(11): 1190-1192, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35934301

RESUMO

Endometrial ablation can be performed using a variety of techniques, including resectoscopic or non-resectoscopic approaches. In this study, we compared 2 resectoscopic endometrial ablation techniques. The first technique was rollerball coagulation followed by endometrectomy (type A; n = 103), and the second was the reverse (type B; n = 107). Besides excessive bleeding in 4 cases, the procedures were uneventful in both groups of patients. We did not encounter uterine perforation or cervical laceration. Satisfaction rates were 97% and 99% with an overall hysterectomy rate of 2.9%. These results compared favorably with those in the literature. The results of our study show that hysteroscopic endometrectomy is effective with few associated complications.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Feminino , Humanos , Gravidez , Menorragia/cirurgia , Técnicas de Ablação Endometrial/métodos , Histerectomia , Histeroscopia/métodos , Endométrio , Resultado do Tratamento
16.
BMC Womens Health ; 22(1): 257, 2022 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-35761328

RESUMO

BACKGROUND: It is estimated that between 12 to 25% of women who undergo an endometrial ablation for heavy menstrual bleeding (HMB) are dissatisfied after two years because of recurrent menstrual bleeding and/or cyclical pelvic pain, with around 15% of these women ultimately having a hysterectomy. The insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after endometrial ablation may inactivate residual untreated endometrium and/or inhibit the regeneration of endometrial tissue. Furthermore, the LNG-IUS may prevent agglutination of the uterine walls preventing intrauterine adhesion formation associated with endometrial ablation. In these ways, insertion of an LNG-IUS immediately after endometrial ablation might prevent subsequent hysterectomies because of persisting uterine bleeding and cyclical pelvic pain or pain that arises de novo. Hence, we evaluate if the combination of endometrial ablation and an LNG-IUS is superior to endometrial ablation alone in terms of reducing subsequent rates of hysterectomy at two years following the initial ablative procedure. METHODS/DESIGN: We perform a multicentre randomised controlled trial in 35 hospitals in the Netherlands. Women with heavy menstrual bleeding, who opt for treatment with endometrial ablation and without contraindication for an LNG-IUS are eligible. After informed consent, participants are randomly allocated to either endometrial ablation plus LNG-IUS or endometrial ablation alone. The primary outcome is the hysterectomy rate at 24 months following endometrial ablation. Secondary outcomes include women's satisfaction, reinterventions, complications, side effects, menstrual bleeding patterns, quality of life, societal costs. DISCUSSION: The results of this study will help clinicians inform women with HMB who opt for treatment with endometrial ablation about whether concomitant use of the LNG-IUS is beneficial for reducing the need for hysterectomy due to ongoing bleeding and/or pain symptoms. Trial registration Dutch Trial registration: NL7817. Registered 20 June 2019, https://www.trialregister.nl/trial/7817 .


Assuntos
Anticoncepcionais Femininos , Técnicas de Ablação Endometrial , Dispositivos Intrauterinos Medicados , Menorragia , Anticoncepcionais Femininos/uso terapêutico , Técnicas de Ablação Endometrial/métodos , Feminino , Humanos , Levanogestrel/uso terapêutico , Menorragia/cirurgia , Estudos Multicêntricos como Assunto , Dor Pélvica/etiologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Acta Obstet Gynecol Scand ; 101(8): 923-930, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35624547

RESUMO

INTRODUCTION: Minimally invasive methods to reduce menorrhagia were introduced in the 1980s and 1990s. Transcervical endometrial resection (TCRE) and endometrial ablation (EA) are two of the most frequently used methods. As none of them can guarantee a complete removal of the endometrium, there are concerns that the remaining endometrium may develop to endometrial cancer (EC) later in life. The primary aim was to analyze the long-term incidence of EC after TCRE and EA in a nationwide population. The secondary aim was to assess the two treatment modalities separately. MATERIAL AND METHODS: The Swedish National Patient Registry and National Quality Registry for Gynecological Surgery were used for identification of women who had TCRE or EA performed between 1997-2017. The cohort was followed from the first TCRE or EA until hysterectomy, diagnosis of EC, or death. Follow-up data were retrieved from the National Cancer Registry and the National Death Registry. Expected incidence for EC in Swedish women was calculated using Swedish data retrieved from the NORDCAN project after having taken into account differences of age and follow-up time. Cumulative incidence of EC after TCRE and EA, was calculated. A standardized incidence ratio was calculated based on the expected and observed incidence, stratified by age and year of diagnosis. RESULTS: In total, 17 296 women (mean age 45.1 years) underwent TCRE (n = 8626) or EA (n = 8670). Excluded were 3121 who had a hysterectomy for benign causes during follow up. During a median follow-up time of 7.1 years (interquartile range 3.1-13.3 years) the numbers of EC were 25 (0.3%) after TCRE and 2 (0.02%) after EA, respectively. The observed incidence was significantly lower than expected (population-based estimate) after EA but not after TCRE, giving a standardized incidence ratio of 0.13 (95% confidence interval [CI] 0.03-0.53) after EA and 1.27 (95% CI 0.86-1.88) after TCRE. Median times to EC were 3.0 and 8.3 years after TCRE and EA, respectively. CONCLUSIONS: There was a significant reduction of EC after EA, suggesting a protective effect, whereas endometrial resection showed an incidence within the expected rate.


Assuntos
Técnicas de Ablação Endometrial , Neoplasias do Endométrio , Menorragia , Técnicas de Ablação Endometrial/efeitos adversos , Neoplasias do Endométrio/epidemiologia , Neoplasias do Endométrio/cirurgia , Endométrio/cirurgia , Feminino , Humanos , Histerectomia/efeitos adversos , Histerectomia/métodos , Incidência , Menorragia/cirurgia , Pessoa de Meia-Idade , Suécia/epidemiologia
18.
J Obstet Gynaecol ; 42(6): 2164-2169, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35170390

RESUMO

MEA (microwave endometrial ablation) is a treatment that can control hypermenorrhea. With the increase in the number of caesarean sections and myomectomies, an increasing number of patients with MEA have undergone previous incision of the uterine myometrium. Uterine perforation is major complication. Here we compared the incidence of complications and recurrence between groups with or without previous uterine surgery. 35 patients who underwent MEA were enrolled in the study. We assessed the thickness of uterine myometrium by MRI and transvaginal ultrasonography (TV-US). 12 patients (34%) had previous uterine surgery; Among 12 patients with previous uterine surgery, 6 (50%) showed thinning of the myometrium. No patient showed any complications. There was no difference in recurrence rate between two groups (1/12 = 8% and 2/23 = 8%, respectively). MEA can be performed safely and effectively even for patients with previous uterine surgery.IMPACT STATEMENTWhat is already known on this subject? MEA (microwave endometrial ablation) is a treatment that can control hypermenorrhea.A few serious complications have been reported, including uterine perforation and intestinal injury. There have been no collective reports on women with a history of uterine surgery, and the decision to perform MEA and the detailed procedures have not been clarified.What do the results of this study add? No patient who received MEA showed any complication regardless of previous uterine surgery. There was no difference in recurrence rate of hypermenorrhea between groups with and without previous uterine surgery. MEA could be performed safely and effectively in patients with previous uterine surgery preoperative imaging and intraoperative ultrasoundsWhat are the implications of these findings for clinical practice and/or further research? Curently, with the increase in the number of caesarean sections and myomectomies, the increasing number of patients with MEA have undergone previous incision of the uterine myometrium and this causes thinning of the myometrium. MEA can be safely performed without losing any therapeutic effect, even in patients with a history of uterine surgery, by using MRI and TV-US as preoperative evaluations.


Assuntos
Técnicas de Ablação Endometrial , Menorragia , Perfuração Uterina , Técnicas de Ablação Endometrial/efeitos adversos , Técnicas de Ablação Endometrial/métodos , Feminino , Humanos , Menorragia/etiologia , Micro-Ondas/uso terapêutico , Projetos Piloto , Gravidez , Perfuração Uterina/complicações
19.
Surg Technol Int ; 40: 179-189, 2022 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-35158402

RESUMO

In this final section of our three-part series, we will apply the basic and intermediate skills described in the first two parts to advance the gynecologist's skills to accomplish the most demanding of resectoscopic surgical challenges. In Part I of this series, we reviewed the benefits of the continuous flow gynecologic resectoscope (CFGR) and how the motivated gynecologist can assemble an operative team and overcome the impediments to learning the use of this versatile and minimally invasive instrument. In this first section, we outlined and analyzed basic resectoscopic surgery-endometrial ablation, the resection of small submucous myomas and endometrial polyps, as well as the treatment of mild Asherman's syndrome and the removal of retained products of conception. In Part II-intermediate level resectoscopic surgery-we introduced procedures such as endomyometrial resection, the resection of intermediate-size submucous leiomyomas, hysteroscopic metroplasty, and endocervical resection. Though it is not considered an absolute requirement to accomplish procedures at this level, sonographic guidance was introduced in preparation for more challenging cases. In Part III, the author reviews advanced resectoscopic procedures in which sonographic guidance is a requirement for the management of severe intrauterine adhesions and late-onset endometrial ablation failures, the management of FIGO Type 3 and 4 intramural myomas, as well as large submucous myomas.


Assuntos
Técnicas de Ablação Endometrial , Leiomioma , Mioma , Neoplasias Uterinas , Técnicas de Ablação Endometrial/métodos , Feminino , Humanos , Histeroscopia/métodos , Leiomioma/diagnóstico por imagem , Leiomioma/cirurgia , Mioma/cirurgia , Neoplasias Uterinas/cirurgia
20.
J Obstet Gynaecol ; 42(5): 1358-1364, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34689685

RESUMO

This retrospective study assessed the efficacy and long-term satisfaction of radiofrequency endometrial ablation outside the context of clinical trials in 408 women, and compared the outcome between office-setting (211, 52%) and day-case procedures under general anaesthetics (197, 48%). The Kaplan Meir time-to-event analysis showed that the cumulative number of women undergoing surgical re-intervention was 32 with a probability of 9.4% (95% CI: 6.3 - 12.5%) at 2-years, and 45 with a probability of 14.5% (95% CI: 10.3 - 18.2%) at 5-years. There was no statistically significant difference in the re-intervention rate between office and day-case groups (HR = 0.7, 95% CI: 0.68 - 3.1, p = .3). The satisfaction rate, measured by Visual Analogue Scale, was not statistically different (p = .5) between office (109; 80.7%) and day-case (96; 82.8%) groups. This study showed lower surgical re-intervention rate than previously reported in observational studies, and high rates of long-term women satisfaction. The outcomes were similar in office and day-case settings.Impact statementWhat is already known on this subject? Previous studies have shown the safety and effectiveness of radiofrequency endometrial ablation for treating heavy periods. However, studies investigating it, outside clinical trials, either included a small sample size, a short-term follow-up, poor reporting so that it is impossible to judge whether some women underwent re-intervention in another centre, failed to discriminate in analysis between second-generation techniques, or assessed only short-term satisfaction.What do the results of this study add? This is the largest series reported from a single centre and the first study reporting long-term satisfaction in women, outside clinical trials. Surgical re-intervention was used as the primary outcome measure which is an objective measure rather than the change in the monthly flow which is rather subjective. More importantly, the study records the similarity, in the outcome and women's satisfaction rate, between office and day-case procedures under general anaesthetics.What are the implications of these findings for clinical practice and/or further research? Endometrial ablation service is widely implemented in office-setting in the UK. We hope the result of this study encourages implementation on a larger scale in office across centres in the world with its multiple advantages both to women and service alike.


Assuntos
Anestésicos Gerais , Técnicas de Ablação Endometrial , Menorragia , Anestésicos Gerais/uso terapêutico , Técnicas de Ablação Endometrial/métodos , Endométrio/cirurgia , Feminino , Humanos , Menorragia/tratamento farmacológico , Satisfação do Paciente , Estudos Retrospectivos , Resultado do Tratamento
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