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Giornale Journal of minimally invasive gynecology
Year 2017
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STUDY OBJECTIVE: To compare surgical experience of laparoscopic/robotic myomectomy in premenopausal patients pretreated with ulipristal acetate (UPA) with women not hormonally pretreated. DESIGN: A retrospective, multicenter cohort study of laparoscopic/robotic myomectomy procedure videos (Canadian Task Force Classification III). SETTING: Multiple university-affiliated tertiary care hospitals. PATIENTS: Fifty-five premenopausal women who underwent laparoscopic/robotic myomectomy for intramural myomas and were either pretreated with 3 months of UPA or had no hormonal pretreatment. INTERVENTIONS: Laparoscopic/robotic myomectomy surgical videos were independently reviewed by 2 gynecologists blinded to whether or not patients received pretreatment with UPA. Each procedure was scored using a novel 22-point surgical global rating tool containing 6 subscales: depth of myometrial incision, ease of myoma-myometrium cleavage plane identification, ease of myoma detachment, blood loss during myoma detachment, myometrial blood loss after myoma detachment, and myoma consistency. MEASUREMENTS AND MAIN RESULTS: Participating surgeons submitted 55 videos of laparoscopic/robotic myomectomy procedures recorded over a 3-year period (2012-2015). Fifty met the inclusion criteria (25 UPA-treated patients and 25 patients without hormonal pretreatment). Patients treated with UPA were more likely to be older than patients with no medical pretreatment (mean age = 33.5 vs 38.3 years, p = .002). There were no statistically significant differences regarding other baseline characteristics such as the largest diameter of myoma removed, the number of myomas removed, or the estimated blood loss. There was no difference in the physician assessors' mean global rating score for patients with UPA pretreatment versus no pretreatment (12.4 vs 13.4, p = .23). Within the 6 subscales, no differences were observed between the 2 groups. Each video was graded independently by 2 assessors, and there was high inter-rater agreement for the total score and each subscale. CONCLUSION: There was no difference in surgical experience for myomectomies of patients pretreated with UPA versus those without medical pretreatment.

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Giornale Journal of robotic surgery
Year 2016
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Gonadotropin-releasing hormone (GnRH) agonist therapy is used before myomectomy to decrease the size of the fibroids, but its association with fibroid recurrence postoperatively remains unsettled. We undertook a retrospective study of robotic-assisted myomectomy (RM) patients at our academic medical center to determine symptomatic recurrence and reoperation rates in those who did versus did not receive preoperative GnRH therapy. Only patients, who had their index myomectomy at least 2 years prior to the chart review, were included in this study. Of 118 RM patients identified between January 2005 and December 2009, 17 patients (14.4 %) had symptomatic recurrence as early as 5 months to as late as 30 months postoperatively. The symptomatic recurrence group had significantly higher preoperative GnRH use (35 vs 9 % non-recurrence; p = 0.009). A total of 7.6 % of all patients underwent reoperation. GnRH agonist use was significantly higher in the reoperation group (56 vs 9 % no reoperation; p = 0.002). Cavity entry during the initial surgery was also more frequent in the reoperation group (56 vs 20 %; p = 0.030), whereas the presence of multiple fibroids, size of the largest leiomyoma, and uterine volume were not statistically different between groups. Our study is among the earliest to report RM reoperation rates in patients receiving preoperative GnRH therapy, showing that the role of GnRH agonist therapy to shrink myomas may not be beneficial when measured against risk of disease recurrence.

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Giornale European journal of obstetrics, gynecology, and reproductive biology
Year 2016
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OBJECTIVE: To assess the usefulness of 3-month treatment with ulipristal acetate (UPA) before laparoscopic myomectomy of large uterine myomas. STUDY DESIGN: This retrospective analysis of a prospectively collected database included women of reproductive age requiring laparoscopic myomectomy with the following characteristics: FIGO type 3, 4 or 5 myomas; largest diameter of the main myoma ≥10cm; number of myomas ≤3; largest diameters of the other myomas ≤5cm (second myoma) and ≤3cm (third myoma). Patients either underwent direct surgery (group S) or were treated before surgery with UPA for 3 months (group UPA). RESULTS: The mean (±SD) intraoperative blood loss was lower in group UPA (507.1±214.9ml) than in group S (684.2±316.8; p=0.012). The total operative time was lower in group UPA (137.6±26.8min) than in group S (159.7±26.8min; p<0.001); there was no significant difference in the suturing time between the two study groups (p=0.076). Hemoglobin drop was lower in group UPA (1.1±0.5g/dl) than in group S (1.3±0.7g/dl; p=0.034). Six patients in group S and no patient in group UPA required postoperative blood transfusions (p=0.031). Complications were not different between the two groups (p=0.726). Moreover, preoperative treatment with UPA caused a significant increase in hemoglobin levels (11.9±1.6g/dl) compared with baseline (9.1±1.1g/dl; p<0.001). CONCLUSION: A 3-month treatment with UPA before laparoscopy for large uterine myomas decreases intraoperative blood loss, hemoglobin drop, postoperative blood transfusion and length of surgery.

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Giornale Journal of minimally invasive gynecology
Year 2015
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STUDY OBJECTIVE: To evaluate the efficacy of gonadotropin-releasing hormone analogue (GnRHa) use before laparoscopic myomectomy (LM) in large myomas. DESIGN: Prospective study (Canadian Task Force classification II-1). SETTING: University-affiliated hospital. PATIENTS: Ninety-one women with large myomas (≥10 cm) or more than 2 myomas ≥ 5 cm underwent LM between July 2011 and March 2014. INTERVENTIONS: Forty patients underwent LM after GnRHa use (group A) and 51 underwent LM only (group B). GnRHa was used for 3 doses every 4 weeks before LM in group A. MEASUREMENTS AND MAIN RESULTS: Group A had a significantly smaller maximum diameter of the largest myoma than group B (8.5 ± 2.1 vs 10.7 ± 2.4, p < .001) and fewer patients with myomas larger than 10 cm after GnRHa administration (33% vs 67%, p = .001). In group A, there was a decrease in 2 or more myomas ≥ 5 cm (20% vs 50%) after GnRHa use. Group A also had significantly smaller mean myoma weight (448 vs 567 g, p = .045) and significantly shorter mean operative time (129 ± 30 vs 152 ± 34 minutes, p = .001). Most patients in group A (40%) had an operative time < 119 minutes, whereas most patients in group B (37%) had an operative time between 150 and 179 minutes. Group A also had less intraoperative blood loss (84 ± 53 vs 137 ± 166 mL, p < .001), drop in hemoglobin (1.5 ± 0.8 vs 3.0 ± 1.7 g/dl, p < .001), excessive bleeding (5% vs 33%, p = .001), postoperative hematoma (2.5% vs 9.8%, p = .168), and blood transfusion (7.5% vs 35%, p = .001). CONCLUSION: GnRHa before LM in large myomas may be an effective adjuvant treatment for women with large and multiple myomas. This method is beneficial in decreasing operative time, intraoperative bleeding, postoperative hemorrhage, and need of blood transfusion.

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Giornale Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology
Year 2014
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The aim of this randomised prospective study was to investigate the impact of preoperative gonadotrophin-releasing hormone agonist (GnRHa) compared with a control group with myomectomy. A total of 36 women (n = 36, group 1) with fibroids were randomised to receive either two monthly doses (n = 18/36, group 1a) or three monthly doses of goserelin (n = 18/36, group 1b) prior to myomectomy. The 32 women who received no treatment (group 2) comprised the controls. All patients had similar demographic features. There were no significant differences among the three groups with respect to: (1) mean intraoperative blood loss; (2) preoperative and postoperative blood transfusion or (3) length of hospital stay. The only advantage of administering GnRHa prior to myomectomy for symptomatic fibroids in our population was a higher haemoglobin level prior to surgery among the women who received three doses of the drug.

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Giornale Fertility and Sterility
Year 2013
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Giornale International journal of women's health
Year 2013
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Objective: To evaluate the efficacy, safety, and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids. Design: Randomized, double-blind clinical study. Location: Eusebio Hernández Gynecology and Obstetrics Teaching Hospital, Havana, Cuba. Subjects: One hundred twenty-four subjects with symptomatic uterine fibroids. Treatment: One daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months. Variables in evaluating safety: Changes in fibroid and uterine volumes, changes in symptom prevalence and intensity, and changes in quality of life. Results: Three months into treatment, fibroid volume was reduced by 28.5% in the mifepristone group with an increase of 1.8% in the placebo group (P= 0.031). There were significant differences between the groups with respect to pelvic pain prevalence (P=0.006), pelvic pressure (P=0.027), rectal pain (P=0.013), hypermenorrhea (P<0.001), and metrorrhagia (P=0.002) at the end of treatment. Amenorrhea was 93.1% and 4.3% in the mifepristone and placebo groups, respectively (P<0.001). Treatment side effects were significantly greater in the mifepristone group. Estradiol levels did not differ significantly between the placebo and mifepristone groups at the end of treatment. Improvement in quality of life was significantly greater in the categories of "symptoms" (P=0.004) and "activity" (P=0.045) in the mifepristone group. Conclusion: The 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo. © 2013 Carbonell Esteve et al, publisher and licensee Dove Medical Press Ltd.

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Autori Prasad S , Varun N , Kumar A
Giornale Fertility and Sterility
Year 2013
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Giornale International journal of women's health
Year 2013
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Background: Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF. Objectives: To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial. Methods: A total of 39 reproductive-age women (age 18-50 years, day 3 serum follicle-stimulating hormone,<10 mIU/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm3 or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student's t-test was used to evaluate statistical significance of treatment effect between the two groups. Results: Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss significantly decreased from 71 mL/month to 45 mL/month (P = 0.001). No adverse effects, endometrial hyperplasia, or other endometrial pathology were observed in either group. Conclusion: EGCG shows promise as a safe and effective therapeutic agent for women with symptomatic UFs. Such a simple, inexpensive, and orally administered therapy can improve women's health globally. © 2013 Roshdy et al, publisher and licensee Dove Medical Press Ltd.

Primary study

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Giornale Ceska gynekologie
Year 2012
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OBJECTIVE: To evaluate the role of three-monthly pre-treatment with gonadothropin releasing hormone (GnRH) analogues prior to myomectomy for women in comparison with control group of patients with no application. Analysis is focused on peroperative and postoperative results of surgery treatment for women with clinically symptomatic uterine fibroids in reproductive age with interest in getting pregnant. DESIGN: Prospective clinical study. SETTING: Gynecological and Obstetric Clinic of Medical Faculty of Masaryk University and the University Hospital Brno. MAIN MEASURES: The group of 212 patients with symptomatic uterine fibroids detected by ultrasound. 90 patients (42.5%) underwent laparoscopic myomectomy (LM) and 122 patients (57.5%) underwent open laparotomic myomectomy (OM). In the selected group we were observing the common number of exstirpated uterine fibroids, their size, anatomical localisation, depth of invasion of dominant exstirpated uterine fibroid in relation to uterine wall. METHODS: Both groups of patients were randomised into two parts. The group LM with GnRH pretreatment contained 42 patients (19,8 %) and control group with no pre-treatment 48 patients (22.7%). Laparotomic part of study was divided into two groups with preoperative application of GnRH analogues 44 patients (36,7 %) and control group OM with no application 44 patients (20.8%). The main outcome measures were peroperative blood loss, duration of surgery, the length of hospital stay, evidence of per- and postoperative complications and the final results by second look laparoscopy (SLL). RESULTS: In the observed group LM with pre-treatment of GnRh analogues there was significantly higher volume of blood loss (p = 0.0003), significantly longer duration of surgery (p = 0.0063) and significantly higher lenght of hospital stay (p = 0.0025) compared with control group. We have not found a significant difference in the incidence of peroperational converse to laparotomy, final result of neoformation of uterus wall and occurrence of postoperative adhesions by SLL in observed LM group compared with control group. In the observed OM group with pre-treatment of GnRH analogues there was no significant difference in: peroperative blood loss (p = 0.5324), duration of surgery (p = 0.3927) neither average length of hospital stay compared with control group. In the OM group, there was significantly lower incidence of recidives of uterine fibroids observed by SLL (p = 0.0025) and no significant difference of occurrence of postoperative adhesions compared with control group. We have not found significant difference in the incidence of peroperative complications, early and late postoperative complications in group of LM and OM in comparison with control groups. CONCLUSION: Application of GnRH analogues in observed group of patients before LM and OM have not lead to improvement of peroperative results in comparison with control group. Pre-treatment of GnRh analogues before OM have lead to significant drop in recidives of uterine fibroids observed by SLL (p = 0.0025) compared with control group.