Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids.

INTRODUCTION: Uterine fibroids affect 30%-77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG's efficacy in treating women with fibroids and unexplained infertility. METHODS AND ANALYSIS: This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores. ETHICS AND DISSEMINATION: The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial. TRIAL REGISTRATION NUMBER: NCT05364008.

Hysteroscopic diode laser myolysis: from a case series to literature review of incisionless myolysis techniques for managing heavy menstrual bleeding in premenopausal women.

PURPOSE: This case series examined the safety and effectiveness of hysteroscopic myolysis using laser-induced interstitial thermo-therapy (LITT) for treating heavy menstrual bleeding (HMB) in premenopausal women with FIGO type 1 or 2 uterine fibroids, not planning for future fertility. Additionally, a comprehensive review of innovative, minimally invasive, incisionless myolysis techniques was conducted. METHODS: Women with HMB, sonographically diagnosed with a single FIGO type 1 or 2 fibroid, underwent hysteroscopic myolysis using the Leonardo® diode laser. Effectiveness was assessed via transvaginal ultrasound measurement of myoma size, volume and vascularization pre and post-procedure. Moreover, we also evaluated any improvements in symptoms using the Pictorial Blood Loss Assessment Chart (PBAC score) scores. RESULTS: The procedure resulted in significant HMB reductions and noticeable fibroid size, volume, and vascularization decrease in all three patients, with no reported complications. The literature review revealed both advantages and limitations of the minimally invasive, incisionless myolysis techniques. CONCLUSIONS: Hysteroscopic laser myolysis is a safe and effective therapeutic intervention for patients experiencing HMB, diagnosed with FIGO type 1 or 2 fibroids, and not planning for future fertility. The procedure resulted in significant reductions in menstrual blood loss and fibroid size. Despite the promising results, it is essential to note the limitations of this report, including its case series design, a small number of patients, and a short follow-up period. Further research is necessary to confirm these results.

Surgical management of uterine fibroids.

PURPOSE OF REVIEW: Fibroids are benign pelvic masses and constitute the most common gynaecological condition. They create a significant health and social burden to many women because of heavy menstrual bleeding and fibroid pressure symptoms. Many women will be faced with the dilemma of surgical management to improve their symptoms at some point of their reproductive age. The aim of this article is to identify current surgical management of fibroids describing the technical steps, advantages, disadvantages and risks of each method. RECENT FINDINGS: The surgical management of fibroids remains challenging, as the overall prevalence, the clinical experience and the patient awareness is increasing because of an upgrade in our sonographic and magnetic resonance diagnostic tools. Unfortunately not every patient is able to benefit from tailor-made surgery that holistically evaluates individual needs including fertility aspirations. SUMMARY: This article provides the most current synopsis of every available surgical modality for fibroid management. Large prospective multicentre cohort studies are needed to definitely determine the most suitable operation for any individual suffering with fibroids; and perhaps artificial intelligence may offer a valuable tool in the future data analysis.

A Systematic Review of Minimally Invasive Approaches to Uterine Fibroid Treatment for Improving Quality of Life and Fibroid-Associated Symptoms.

Improvement in symptom severity and quality of life (QoL) are critical concerns for women with fibroids as they evaluate treatment options. This systematic review analyzed available evidence regarding minimally invasive approaches to fibroid treatment and compared validated QoL and fibroid-associated symptom scores before and after treatment. A comprehensive search was conducted using PubMed, Embase, Cochrane Library, and Scopus from January 1990 to July 2020. English-language publications were included if they evaluated associations between minimally invasive approaches to fibroid treatment and QoL or fibroid-associated symptoms, and they used validated questionnaires before and after treatment. QoL or fibroid-associated symptom scores were compared and summarized for each minimally invasive approach. Thirty-seven studies were ultimately included in this review: 26 evaluating individual approaches and 11 which were comparative studies of minimally invasive approaches and surgical interventions. Radiofrequency ablation (RFA) and ultrasound-guided sclerotherapy (USGS) significantly improved overall QoL. Uterine artery embolization (UAE) and ultrasound-guided high-intensity frequency ultrasound (US-HIFU) improved overall QoL to a similar extent as surgical interventions. Twenty-eight studies assessed fibroid-associated symptoms with the Uterine Fibroid Symptoms Quality of Life Questionnaire (UFS-QoL). UAE, magnetic resonance imaging-guided high-intensity frequency ultrasound (MR-HIFU), US-HIFU, RFA, and percutaneous microwave ablation (PMWA) significantly decreased Symptom Severity Score by a range of 21 to 39 points (out of 100) at 6 months. Minimally invasive approaches to treat fibroids were effective alternatives to surgical interventions for improving quality of life, fibroid-associated symptoms, and pain. Outcomes among minimally invasive approaches were similar, presenting patients with numerous options for fibroid treatment.

A measure for perioperative anxiety symptoms in patients with FUAS - treated uterine fibroids: development and validation.

OBJECTIVE: To develop a scale that measured the perioperative anxiety symptoms of uterine fibroids (PASM-UF) treated with focused ultrasound ablation surgery (FUAS). METHODS: A panel of gynecologists, nurses, and patient-reported outcome (PRO) experts created a draft of the PASM-UF scale. Women who underwent FUAS for uterine fibroids were recruited for its psychometric validation. Assessments were conducted during admission, before surgery, and at discharge. The Symptom Checklist-90 (SCL-90) was administered to assess criterion validity. We assessed the relationship between the developed PASM-UF and the SCL-90 via a correlation analysis. Cronbach's alpha was used to assess internal consistency for reliability. RESULTS: We included five items, pain, lack of appetite, fatigue (tiredness), disturbed sleep, and anxiety, in the final version of the PASM-UF. Data were collected from 228 patients. Cronbach's alpha was 0.745, whereas the correlation coefficient between SCL-90 and PASM-UF was 0.345 (p < 0.001). The total PASM-UF scores were significantly higher in patients whose SCL-90 scores were ≥160 compared to those with <160 (9.85 ± 9.07 vs. 4.01 ± 5.15, p = .002). Those who did not complete the SCL-90 reported lower PASM-UF scores than those who did (2.33 ± 3.27 vs. 4.67 ± 5.99, p = .006). Patients reported significantly lower PASM-UF scores postoperatively than preoperatively (2.95 ± 4.18 vs. 3.92 ± 4.90, p = .002). CONCLUSIONS: The PASM-UF is a valid, reliable, and sensitive scale for assessing perioperative anxiety levels among women with uterine fibroids. Statistical analysis suggests that it is also an effective instrument for scientific research.Key MessageWe developed a brief scale to assess anxiety in perioperative patients with uterine fibroids. In addition, the scale monitored the anxiety levels at multiple frequencies and did not increase burden on the patients. The scale has been proven to be effective, reliable, and highly sensitive.

Minimally invasive myomectomy: practice trends and differences between Black and non-Black women within a large integrated healthcare system.

BACKGROUND: Although multiple professional organizations encourage minimally invasive surgical approaches whenever feasible, nationally, fewer than half of myomectomies are performed via minimally invasive routes. Black women are less likely than their non-Black counterparts to have minimally invasive surgery. OBJECTIVE: This study aimed to assess the trends in surgical approach among women who underwent minimally invasive myomectomies for uterine leiomyomas within a large integrated healthcare system as initiatives were implemented to encourage minimally invasive surgery, particularly evaluating differences in the proportion of minimally invasive surgery performed in Black vs non-Black women. STUDY DESIGN: We conducted a retrospective cohort study of women, aged ≥18 years, who underwent a myomectomy for a uterine leiomyoma within Kaiser Permanente Northern California between 2009 and 2019. Generalized estimating equations and Cochran-Armitage testing were used to assess myomectomy incidence and linear trend in the proportions of myomectomy by surgical route-abdominal myomectomy and minimally invasive myomectomy. Multivariable logistic regression analyses were used to assess the associations between surgical route and (1) race and ethnicity and (2) complications, controlling for patient demographic, clinical, and surgical characteristics. RESULTS: A total of 4033 adult women underwent a myomectomy during the study period. Myomectomy incidence doubled from 0.12 (95% confidence interval, 0.12-0.13) per 1000 women in 2009 to 0.25 (95% confidence interval, 0.24-0.25) per 1000 women in 2019 (P<.001). During the 11-year study period, the proportion of minimally invasive myomectomy increased from 6.0% to 89.5% (a 15-fold increase). The proportion of minimally invasive myomectomy in Black women remained lower than in non-Black women (54.5% vs 64.7%; P<.001). Black women undergoing myomectomy were younger (36.4±5.6 vs 37.4±5.8 years; P<.001), had a higher mean fibroid weight (436.0±505.0 vs 324.7±346.1 g; P<.001), and had a higher mean body mass index (30.8±7.3 vs 26.6±5.9 kg/m2; P<.001) than their non-Black counterparts. In addition to patient race, surgery performed between 2016 and 2019 compared with surgery performed between 2009 and 2012 and higher surgeon volume compared with low surgeon volume were associated with an increased proportion of minimally invasive myomectomy (adjusted relative risks, 12.58 [95% confidence interval, 9.96-15.90] and 6.63 [95% confidence interval, 5.35-8.21], respectively). Black race and fibroid weight of >500 g each independently conferred lower rates of minimally invasive myomectomy. In addition, there was an interaction between race and fibroid weight such that Black women with a fibroid weight of ≤500 g or >500 g were both less likely to have minimally invasive myomectomy than non-Black women with a fibroid weight of ≤500 g (adjusted relative risks, 0.74 [95% confidence interval, 0.58-0.95] and 0.26 [95% confidence interval, 0.18-0.36], respectively). Operative, perioperative, and medical complications were low during the 11-year study period. In regression analyses, after controlling for race, age, fibroid weight, parity, low-income residence, body mass index, surgeon volume, and year of myomectomy, the risk of complications was not markedly different comparing abdominal myomectomy with minimally invasive myomectomy. Similar results were found comparing laparoscopic minimally invasive myomectomy with robotic-assisted minimally invasive myomectomy except for women who underwent laparoscopic minimally invasive myomectomy had a lower risk of experiencing any medical complications than those who underwent robotic-assisted minimally invasive myomectomy (adjusted relative risk, 0.27; 95% confidence interval, 0.09-0.83; P=.02). CONCLUSION: Within an integrated healthcare delivery system, although initiatives to encourage minimally invasive surgery were associated with a marked increase in the proportion of minimally invasive myomectomy, Black women continued to be less likely to undergo minimally invasive myomectomy than their non-Black counterparts. Race and fibroid weight alone did not explain the disparities in minimally invasive myomectomy.

Uterine Fibroids in Black Women: A Race-Stratified Subgroup Analysis of Treatment Outcomes After Laparoscopic Radiofrequency Ablation.

Background: The disease and treatment burden of uterine fibroids (UF) in Black women is substantially greater compared with other racial groups, with higher rates of complications and poorer outcomes with both hysterectomy and myomectomy. The inequities in the access Black women have to minimally invasive routes of surgery contribute to their burden of illness. Laparoscopic radiofrequency ablation (LAP-RFA) is a minimally invasive, safe, and effective uterine-sparing treatment option. Methods: This subgroup analysis of the LAP-RFA Pivotal Trial stratified outcomes by race comparing White women (n = 28, 21%) versus Black women (n = 46, 34%). Results: At baseline, Black women had more fibroids on average (7.3 vs. 3.7; P ≤ 0.001), a greater symptom severity score (SSS) (P ≤ 0.001), and a lower health-related quality of life (HRQoL) score (P = 0.005) than White women. At 36 months post-treatment with LAP-RFA, the statistical differences that existed with baseline SSS and HRQoL score were eliminated between Black and White women. Menstrual blood loss (140.1 mL vs. 127.02 mL; P = 0.44) and mean fibroid volume reduction (47.5 cm3 vs. 36.0 cm3; P = 0.17) were similar between Black and White women at 12 months. Although not statistically significant, the intraoperative total blood loss and uterine blood loss was lower in Black women than White women, despite greater operative time (160 minutes vs. 137 minutes; P = 0.09). Conclusions: These results are promising in providing an alternative uterine-sparing option for Black women and may help to provide a minimally invasive option that can address some of the racial inequities in care for Black women with UF.

Comparison between radiofrequency ablation combined with mifepristone and radiofrequency ablation for large uterine fibroids.

OBJECTIVE: To evaluate the clinical outcomes of transvaginal ultrasound-guided (US-guided) radiofrequency ablation (RFA) combined with mifepristone for the treatment of large uterine fibroids. METHODS: Between June 2016 and December 2018, a total of 30 patients with symptomatic uterine fibroids (≥5cm) who underwent transvaginal US-guided RFA combined with mifepristone were included in this retrospective study. A matching cohort of 30 patients underwent transvaginal US-guided RFA without mifepristone as controls. The technical efficacy, complications and mid-term treatment effectiveness were assessed and compared with the controls. RESULTS: The mean volume of uterine fibroid was 168.3 ± 40.1 cm3. The mean ablation time was 23.5 ± 11.3 min in the combined treatment group, which was demonstrably less than that of the RFA group, which was 45.7 ± 6.8 min. The mean number of punctures was 2.2 ± 0.6 in the combined treatment group, which was significantly less than that of the RFA group. No major complications occurred. The mean percentages of regression of fibroid at 3 and 12 months after the course of the combined treatment were 73.3% and 90.1%, respectively, which were significantly more than those of the RFA group. Quality of life and symptom scores improved in both groups but to a greater extent in the combined treatment group. CONCLUSIONS: US-guided RFA combined with mifepristone might be a simple, safe and effective alternative for the treatment of large uterine fibroids.

[Safety and feasibility of laparoscopic double-flap technique in digestive tract reconstruction after proximal gastrectomy for esophagogastric junction tumors larger than 5 cm].

Objective: To investigate the safety and feasibility of laparoscopic double-flap technique (Kamikawa) in digestive tract reconstruction after proximal gastrectomy for esophagogastric junction (EGJ) leiomyoma and gastrointestinal stromal tumor (GIST) with the maximum diameter >5 cm. Methods: A descriptive case-series study was used to retrospectively analyze the data of patients with EGJ leiomyoma and GIST undergoing laparoscopic-assisted proximal gastrectomy and double-flap technique (Kamikawa) at the Department of Gastrointestinal Surgery, Guangdong Hospital of Traditional Chinese Medicine from September 2017 to March 2019. All the tumors invaded the cardia dentate line, and the maximum diameter was >5 cm. After the exclusion of patients requiring emergency surgery and complicating with severe cardiopulmonary diseases, a total of 4 patients, including 3 males and 1 female with age of 29-49 years, were included in this study. After laparoscopic-assisted proximal gastrectomy, the residual stomach was pulled out of the abdominal cavity and marked with methylene blue at the proximal end 3~4 cm from the anterior wall of the residual stomach in the shape of "H". The gastric wall plasma muscular layer was cut along the "H" shape, and the space between the submucosa and the muscular layer was separated to both sides along the longitudinal incision line to make the seromuscular flap. The residual stomach was put back into the abdominal cavity. Under laparoscopy, 4 stitches were intermittently sutured at the upside of "H" shape and 4-5 cm from the posterior wall of the esophageal stump. The stump of the esophagus was cut open, and the submucosa and mucosa were cut under the "H" shape to enter the gastric cavity. The posterior wall of the esophageal stump was sutured continuously with the gastric stump mucosa and submucosa under laparoscopy. The anterior wall of the esophageal stump was sutured continuously with the whole layer of the residual stomach. The anterior wall of the stomach was sutured to cover the esophagus. The anterior gastric muscle flap was sutured and embedded in the esophagus to complete the reconstruction of digestive tract. The morbidity of intraoperative complications and postoperative reflux esophagitis and anastomosis-related complications were observed. Results: All the 4 patients completed the operation successfully, and there was no conversion to laparotomy. The median operative time was 239 (192-261) minutes, the median Kamikawa anastomosis time was 149 (102-163) minutes, and the median intraoperative blood loss was 35 (20-200) ml. The abdominal drainage tube and gastric tube were removed, and the fluid diet was resumed on the first day after surgery in all the 4 patients. The median postoperative hospitalization time was 6 (6-8) days. Postoperative pathology revealed 3 leiomyomas and 1 GIST. There were no postoperative complications such as anastomotic leakage or stenosis, and no reflux symptoms were observed. The median follow-up time was 22 (11-29) months after the operation, and no reflux esophagitis occurred in any of the 4 patients by gastroscopy. Conclusion: For >5 cm EGJ leiomyoma or GIST, double-flap technique (Kamikawa) used for digestive tract reconstruction after proximal gastrectomy is safe and feasible.

Safety and feasibility of laparoscopic double-flap technique in digestive tract reconstruction after proximal gastrectomy for esophagogastric junction tumors larger than 5 cm / 中华胃肠外科杂志

Objective: To investigate the safety and feasibility of laparoscopic double-flap technique (Kamikawa) in digestive tract reconstruction after proximal gastrectomy for esophagogastric junction (EGJ) leiomyoma and gastrointestinal stromal tumor (GIST) with the maximum diameter >5 cm. Methods: A descriptive case-series study was used to retrospectively analyze the data of patients with EGJ leiomyoma and GIST undergoing laparoscopic-assisted proximal gastrectomy and double-flap technique (Kamikawa) at the Department of Gastrointestinal Surgery, Guangdong Hospital of Traditional Chinese Medicine from September 2017 to March 2019. All the tumors invaded the cardia dentate line, and the maximum diameter was >5 cm. After the exclusion of patients requiring emergency surgery and complicating with severe cardiopulmonary diseases, a total of 4 patients, including 3 males and 1 female with age of 29-49 years, were included in this study. After laparoscopic-assisted proximal gastrectomy, the residual stomach was pulled out of the abdominal cavity and marked with methylene blue at the proximal end 3~4 cm from the anterior wall of the residual stomach in the shape of "H". The gastric wall plasma muscular layer was cut along the "H" shape, and the space between the submucosa and the muscular layer was separated to both sides along the longitudinal incision line to make the seromuscular flap. The residual stomach was put back into the abdominal cavity. Under laparoscopy, 4 stitches were intermittently sutured at the upside of "H" shape and 4-5 cm from the posterior wall of the esophageal stump. The stump of the esophagus was cut open, and the submucosa and mucosa were cut under the "H" shape to enter the gastric cavity. The posterior wall of the esophageal stump was sutured continuously with the gastric stump mucosa and submucosa under laparoscopy. The anterior wall of the esophageal stump was sutured continuously with the whole layer of the residual stomach. The anterior wall of the stomach was sutured to cover the esophagus. The anterior gastric muscle flap was sutured and embedded in the esophagus to complete the reconstruction of digestive tract. The morbidity of intraoperative complications and postoperative reflux esophagitis and anastomosis-related complications were observed. Results: All the 4 patients completed the operation successfully, and there was no conversion to laparotomy. The median operative time was 239 (192-261) minutes, the median Kamikawa anastomosis time was 149 (102-163) minutes, and the median intraoperative blood loss was 35 (20-200) ml. The abdominal drainage tube and gastric tube were removed, and the fluid diet was resumed on the first day after surgery in all the 4 patients. The median postoperative hospitalization time was 6 (6-8) days. Postoperative pathology revealed 3 leiomyomas and 1 GIST. There were no postoperative complications such as anastomotic leakage or stenosis, and no reflux symptoms were observed. The median follow-up time was 22 (11-29) months after the operation, and no reflux esophagitis occurred in any of the 4 patients by gastroscopy. Conclusion: For >5 cm EGJ leiomyoma or GIST, double-flap technique (Kamikawa) used for digestive tract reconstruction after proximal gastrectomy is safe and feasible.

500 Cases of High-intensity Focused Ultrasound (HIFU) Ablated Uterine Fibroids and Adenomyosis.

OBJECTIVE: Clinical outcomes of 500 high-intensity focused ultrasound (HIFU)-treated uterine fibroids and adenomyosis are analyzed and presented. MATERIALS AND METHODS: This is a retrospective cross-sectional analysis from a single tertiary medical center. From April 2015 to October 2018, 546 cases were enrolled for the study. After excluding 46 patients with less than 3 months of follow-up period, there were 404 fibroids, 149 adenomyosis and 53 mixed conditions entered for analysis. The patients' uterine fibroids and adenomyosis were treated by HIFU according to Chongqing Haifu protocol, with 12 cm diameter transducer of focal length 10-16  cm at 0.8 or 1.6 MHz T2-weight MRI imaging was rendered prior to and 3 month post treatment to assess lesion volume change using non-perfusion volume, which was the primary outcome. Secondary outcomes including quality of life, subjective satisfaction, adverse events and pregnancy rate were determined using self-reported questionnaires. The mean follow up period ranged from 3 to 38 months with an average of 21 months. RESULTS: Three months after HIFU-treated uterine fibroids and adenomyosis, the lesion size reduced 40.2% and 46.3%, respectively. Symptoms all improved with better quality of life for the fibroid group, while those with adenomyosis or combined diseases benefit the most from pain control. Serum CA125 decreased significantly for all studied groups, and LDH only showed improvement for fibroids group. Number of adverse events is comparable to Chongqing data (approximately 10.2%), with mostly mild and self-resolving conditions. No permanent sequelae or death was documented. Twelve pregnancies are reported in this cohort. CONCLUSION: HIFU is safe and effective in treating uterine fibroids and adenomyosis. The results are reproducible if standardized treatment schedules are followed. It is a promising treatment alternative with the advantages of precision, non-invasiveness, rapid recovery and readiness for pregnancy.

Dietary fat intake, erythrocyte fatty acids, and risk of uterine fibroids.

OBJECTIVE: To prospectively evaluate the association between dietary fat intake and risk of uterine fibroids; and to evaluate the association between erythrocyte membrane fatty acid (FA) levels and fibroid risk. DESIGN: Prospective cohort study. Cox proportional hazard models were used to calculate hazard ratios and 95% confidence interval (CI). In a subset of participants 34 individual FAs were measured and logistic regression analysis was used to estimate odds ratios (ORs) and 95% CI for the association between FA tertiles and fibroids. SETTING: Not applicable. PATIENT(S): Premenopausal US women (81,590) in the Nurses' Health Study II, aged 25-42 years at enrollment in 1989 for whom diet was assessed by a food frequency questionnaire. A total of 553 participants with erythrocyte FA measurements. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Cases of fibroids were defined on the basis of self-reported ultrasound or hysterectomy confirmation. RESULT(S): A total of 8,142 cases of ultrasound-confirmed or hysterectomy-confirmed were diagnosed during an 18-year period (1991-2009). No associations were observed between intake of any dietary fats and fibroids in the multivariable models. However, when erythrocyte FAs were examined, an inverse association was observed between total n-3 polyunsaturated FAs and likelihood of fibroids (OR for third versus first tertile, 0.41; 95% CI 0.19-0.89). In addition, total trans FAs were associated with more odds of fibroids (OR for third tertile, 3.33; 95% CI 1.50-7.38). CONCLUSION(S): Our findings provide preliminary suggestions that n-3 polyunsaturated FAs and trans FAs may play a role in fibroid etiology; however, these results should be confirmed in future studies.

Prediction of Occult Uterine Sarcoma before Hysterectomy for Women with Leiomyoma or Abnormal Bleeding.

STUDY OBJECTIVE: To develop a risk prediction model for occult uterine sarcoma using preoperative clinical characteristics in women undergoing hysterectomy for presumed uterine leiomyomata. DESIGN: Cases of uterine sarcoma were identified from the electronic medical records. Age/race-matched controls were selected at a 2:1 ratio (controls:cases) from a cohort of 45 188 women who underwent hysterectomy for uterine leiomyomata or abnormal bleeding during the same time interval. Unadjusted conditional logistic regression was performed to identify risk factors for occult uterine sarcomas, defined as no preoperative suspicion for malignancy. A risk prediction model was developed using a weighted logistic regression model, and the performance of the model was assessed using the receiver operator characteristic curve and corresponding area under the curve. SETTING: A large integrated health care system in California PATIENTS: Women 18 years of age and older who underwent a hysterectomy and were diagnosed with a uterine sarcoma and matched controls from 2006 to 2013. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 117 cases of occult uterine sarcomas that met inclusion criteria during the study period. The final risk prediction model included age, race/ethnicity, number of myomas, uterine weight, uterine size increase, degree of pelvic pain, and recent history of blood transfusion. The risk prediction model showed high accuracy based on the receiver operating characteristic curve method (area under the curve = 0.83; 95% confidence interval, 0.77-0.90); however, the positive predictive values were low (0.048 or less) at all risk thresholds. CONCLUSION: Multiple clinical features are associated with the presence of a uterine sarcoma, but when incorporated into a prediction model, they fail to provide significantly more information about women who may have an unrecognized sarcoma and only marginally improve the certainty about women who are not likely to have sarcoma.

Review of magnetic resonance-guided focused ultrasound in the treatment of uterine fibroids.

Uterine leiomyoma is the most frequently occurring solid pelvic tumor in women during the reproductive period. Magnetic resonance-guided high-intensity focused ultrasound is a promising technique for decreasing menorrhagia and dysmenorrhea in symptomatic women. The aim of this study is to review the role of Magnetic resonance-guided high-intensity focused ultrasound in the treatment of uterine fibroids in symptomatic patients. We performed a review of the MEDLINE and Cochrane databases up to April 2016. The analysis and data collection were performed using the following keywords: Leiomyoma, High-Intensity Focused Ultrasound Ablation, Ultrasonography, Magnetic Resonance Imaging, Menorrhagia. Two reviewers independently performed a quality assessment; when there was a disagreement, a third reviewer was consulted. Nineteen studies of Magnetic resonance-guided high-intensity focused ultrasound-treated fibroid patients were selected. The data indicated that tumor size was reduced and that symptoms were improved after treatment. There were few adverse effects, and they were not severe. Some studies have reported that in some cases, additional sessions of Magnetic resonance-guided high-intensity focused ultrasound or other interventions, such as myomectomy, uterine artery embolization or even hysterectomy, were necessary. This review suggests that Magnetic resonance-guided high-intensity focused ultrasound is a safe and effective technique. However, additional evidence from future studies will be required before the technique can be recommended as an alternative treatment for fibroids.

Review of magnetic resonance-guided focused ultrasound in the treatment of uterine fibroids

Uterine leiomyoma is the most frequently occurring solid pelvic tumor in women during the reproductive period. Magnetic resonance-guided high-intensity focused ultrasound is a promising technique for decreasing menorrhagia and dysmenorrhea in symptomatic women. The aim of this study is to review the role of Magnetic resonance-guided high-intensity focused ultrasound in the treatment of uterine fibroids in symptomatic patients. We performed a review of the MEDLINE and Cochrane databases up to April 2016. The analysis and data collection were performed using the following keywords: Leiomyoma, High-Intensity Focused Ultrasound Ablation, Ultrasonography, Magnetic Resonance Imaging, Menorrhagia. Two reviewers independently performed a quality assessment; when there was a disagreement, a third reviewer was consulted. Nineteen studies of Magnetic resonance-guided high-intensity focused ultrasound-treated fibroid patients were selected. The data indicated that tumor size was reduced and that symptoms were improved after treatment. There were few adverse effects, and they were not severe. Some studies have reported that in some cases, additional sessions of Magnetic resonance-guided high-intensity focused ultrasound or other interventions, such as myomectomy, uterine artery embolization or even hysterectomy, were necessary. This review suggests that Magnetic resonance-guided high-intensity focused ultrasound is a safe and effective technique. However, additional evidence from future studies will be required before the technique can be recommended as an alternative treatment for fibroids.

High-intensity focused ultrasound and laparoscopic myomectomy in the treatment of uterine fibroids: a comparative study.

OBJECTIVE: To compare the clinical efficacies of high-intensity focused ultrasound (HIFU) and laparoscopic myomectomy (LM) in the treatment of uterine fibroids and their effects on patients' quality of life. DESIGN: A non-randomised control study. SETTING: Gynaecological department in a university teaching hospital. POPULATION: Patients with uterine fibroids. METHODS: From November 2014 to November 2015, 166 patients with uterine fibroids were enrolled and underwent HIFU (n = 99) and LM (n = 67) surgeries, respectively. Clinical efficacy, postoperative complications and quality of life after treatment were evaluated using the SF-36 Scale to compare the differences in each variable at the 1-year follow up. MAIN OUTCOMES MEASURES: Differences in efficacy, safety and quality of life between the patients treated with HIFU and LM. RESULTS: The 12-month follow-up results showed that the HIFU group had a total effective rate of 99%; only one patient underwent alternative treatment due to non-apparent tumour shrinkage. All patients in the LM group showed complete tumour disappearance. Of these patients, 52 showed significant clinical improvement, 15 with partial clinical improvement, a total effective rate of 98%. There was no significant difference in effectivity rate between the two groups (P > 0.05). Both treatments effectively improved patients' quality of life. Compared with the LM group, patients in the HIFU group experienced no blood loss, a shorter hospital stay and fewer adverse effects and complications, the difference being statistically significant (P < 0.05). CONCLUSIONS: High-intensity focused ultrasound can be as efficacious as LM therapy and effectively improve patients' quality of life in the treatment of uterine fibroids, with fewer adverse effects and complications, shorter hospital stays, and quicker postoperative recovery compared with LM therapy. TWEETABLE ABSTRACT: Patients with uterine fibroids can be effectively treated with both HIFU and myomectomy.

Radiofrequency Thermal Ablation for Uterine Myomas: Long-term Clinical Outcomes and Reinterventions.

STUDY OBJECTIVE: To assess the long-term efficacy and rate of reintervention after ultrasound-guided radiofrequency thermal ablation (RFA) for uterine myomas. DESIGN: A retrospective follow-up, cohort study (Canadian Task Force classification II-2). SETTING: University hospitals and private clinics. PATIENTS: Between November 1, 2007, and February 26, 2010, 66 consecutive women underwent ultrasound-guided RFA. INTERVENTIONS: Patients underwent abdominal or vaginal ultrasound-guided RFA and were contacted for a long-term follow-up to complete the Uterine Fibroid Symptom and Quality of Life Score (UFS-QOL) questionnaire and optional ultrasound and examination. MEASUREMENTS AND MAIN RESULTS: Sixty-six consecutive patients (mean age 45 ± 7 years) with type 2 to 5 symptomatic myomas per the International Federation of Gynecology and Obstetrics (median size = 122.5 cm3 [range, 24-675]) were included. Forty of 62 patients recruited for follow-up underwent no/minor hysteroscopic reinterventions; 35 patients from this group completed the UFS-QOL questionnaire and showed sustained and improved symptom severity scores (100-point scale) from baseline (57.2 ± 16.6) to long-term follow-up (23.8 ± 20.8, p < .001). Twenty-two patients (35%) had major reinterventions (15 hysterectomies and 7 myomectomies). Six of the 22 patients underwent major reinterventions for reasons other than myoma-related complaints. The estimated major reintervention rate because of myoma-related symptoms determined by the Kaplan-Meier method was 13.5% (95% confidence interval [CI], 7%-25%) after 2 years and 29.1% (95% CI, 19%-43%) after 5 years. Women ≥45 years of age had a major reintervention rate of 12% (95% CI, 5%-26%) after 2 years and 19% (95% CI, 10%-35%) after 5 years, and women <45 years had a major reintervention rate of 35.0% (95% CI, 19%-60%) and 73.8% (95% CI, 52%-92%) after 2 and 5 years, respectively. Fewer major reinterventions occurred in women with only 1 RFA-treated myoma (volume ≤180 cm3, diameter <7 cm) than women with more than 1 RFA-treated myoma (>180 cm3, p < .01). The Kaplan-Meier estimates for reintervention in women with only 1 RFA-treated myoma with a volume ≤180 cm3 were 13% (95% CI, 6-28%) and 26% (95% CI, 14%-45%) after 2 and 5 years, respectively. No patients with morphologic myoma characteristics underwent reinterventions. CONCLUSION: Ultrasound-guided RFA for uterine myomas is an alternative treatment option especially for women ≥45 years of age with only 1 myoma (volume ≤180 cm3) and warrants further evaluation.

Minilaparotomy Versus Laparoscopic Myomectomy After Cessation of Power Morcellation: Rate of Wound Complications.

STUDY OBJECTIVE: After the US Food and Drug Administration statement warning against electronic morcellation devices, gynecologic surgeons are performing laparoscopic and robotic myomectomies with minilaparotomy incisions for tissue morcellation and removal. No data exist that focus on the superficial wound complications as a result of these larger incisions. The objective of this study is to compare the rate of wound complications for myomectomy via minilaparotomy versus laparoscopic or robotic myomectomy. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Kaiser Permanente Northern California, a large integrated healthcare delivery system. PATIENTS: Women > 18 years of age who underwent a myomectomy from either complete laparoscopic or robotic approach (LR) were compared with minilaparotomy myomectomy (MM), comprising complete minilaparotomy (ML) and laparoscopic or robotic assisted by a minilaparotomy for morcellation purposes only (LRM) from January 2011 through December 2014. INTERVENTION: Myomectomy via LR, complete ML, and LRM. MEASUREMENTS AND MAIN RESULTS: Medical records were reviewed for outcomes of interest, including superficial wound complications and surgical and demographic data. After exclusion criteria were met, 405 cases were included in the study; 270 cases were classified as MM, which included ML (n = 224), or LRM (n = 46). One hundred thirty-five cases were classified as LR. Parametric and nonparametric analyses were used to compare the 2 groups. There was no significant difference between the groups insofar as patient morbidity, including the primary outcome of wound complications and other postoperative complications; emergency visits; or readmissions. There were 2 (1.5%) wound complications in the LR group and 7 (2.6%) in the MM group (p = .72). Similarly, there were no significant differences in the subcategories of wound complications, including cellulitis, seroma, hematoma, skin separation, wound infection, or postprocedure wound complication. The distribution of estimated blood loss was significantly different between LR and MM groups with an interquartile range of 50 to 150 mL in the LR group versus 50 to 300 mL in the MM group (p < .01). The MM group experienced a shorter procedure time with a median procedure time of 125 minutes compared with 169.5 minutes in LR surgeries (p < .01). The LR group demonstrated a significantly shorter median length of hospital stay (LR 5.0 hours vs MM 23 hours; p < .01). CONCLUSION: Compared with MM, LR is associated with a shorter length of hospital stay and longer operating time but no reduction in wound complication or other patient morbidity.

Occult Uterine Sarcoma and Leiomyosarcoma: Incidence of and Survival Associated With Morcellation.

OBJECTIVE: To estimate the incidence of occult uterine sarcoma and leiomyosarcoma in hysterectomies for leiomyomas and the risk associated with their morcellation. METHODS: We conducted a population-based cohort study. All uterine sarcomas from 2006-2013 in an integrated health care system were identified. Age- and race-specific incidences of occult uterine sarcoma were calculated. Kaplan-Meier survival analysis was performed. Crude and adjusted risk ratios of recurrence and death associated with morcellation at 1, 2, and 3 years were estimated using Poisson regression with inverse probability weighting. RESULTS: There were 125 hysterectomies with occult uterine sarcomas identified among 34,728 hysterectomies performed for leiomyomas. The incidence of occult uterine sarcoma and leiomyosarcoma was 1 of 278 or 3.60 (95% confidence interval [CI] 2.97-4.23) and 1 of 429 or 2.33 (95% CI 1.83-2.84) per 1,000 hysterectomies. For stage I leiomyosarcoma (n=111), eight (7.2%) were power and 27 (24.3%) nonpower-morcellated. The unadjusted 3-year probability of disease-free survival for no morcellation, power and nonpower morcellation was 0.54, 0.19, and 0.51, respectively (P=.15); overall survival was 0.64, 0.75, and 0.68, respectively (P=.97). None of the adjusted risk ratios for recurrence or death were significant except for death at 1 year for power and nonpower morcellation groups combined (6/33) compared with no morcellation (4/76) (5.12, 95% CI 1.33-19.76, P=.02). We had inadequate power to infer differences for all other comparisons including 3-year survival and power morcellation. CONCLUSION: Morcellation is associated with decreased early survival of women with occult leiomyosarcomas. We could not accurately assess associations between power morcellation and 3-year survival as a result of small numbers.

Hysteroscopic Myomectomy of FIGO Type 2 Leiomyomas Under Local Anesthesia: Bipolar Radiofrequency Needle-Based Release Followed By Electromechanical Morcellation.

OBJECTIVE: To demonstrate a technique designed to expand the capabilities of hysteroscopic intrauterine morcellators to deep type 1 and type 2 lesions. The technique comprises "release" of the tumor using a bipolar radiofrequency needle, followed by dissection and extraction with an electromechanical morcellator, all under local anesthesia. DESIGN: Description of technique using images and video (Canadian Task Force classification Class III). SETTING: Office uterine procedure and imaging center; academic medical center. INTERVENTION: Following the administration of local anesthesia and access to the endometrial cavity with a 5.5-mm-o.d. hysteroscopic sheath with a 5 Fr operative channel, a 5 Fr bipolar needle electrode system is used to circumscribe the leiomyoma and enter the pseudocapsule, thereby "releasing" the lesion. Blunt dissection is performed as appropriate and then the system is switched to a hysteroscopic morcellating system (MyoSure; Hologic, Bedford, MA), which is then used to further dissect and remove the target lesion with electromechanical morcellation. CONCLUSION: The development of intrauterine morcellators has facilitated the performance of hysteroscopic myomectomy, especially under local anesthesia, but the side aperture-based design of the systems limits their use in International Federation of Gynecology and Obstetrics (FIGO) type 1 and 2 tumors, particularly those located at the uterine fundus. This technique, based in part on a previously published technique of leiomyoma release, improves access of the electromechanical morcellator to leiomyomas that previously were inaccessible, and minimizes myometrial trauma by dissecting the tumor via the relatively avascular pseudocapsule.