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Ulipristal Acetate and Extracellular Matrix Production in Human Leiomyomas In Vivo: A Laboratory Analysis of a Randomized Placebo Controlled Trial.

Giornale Reproductive sciences (Thousand Oaks, Calif.)
Year 2018
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In a prior randomized controlled study, patients treated with ulipristal acetate (UPA) or placebo for 3 months had a decrease in leiomyoma size. A total of 10 patients' tissue samples (5 placebo and 5 treated with 10 mg/d UPA) that underwent hysterectomy and tissue preservation were identified from this study. Quantitative real-time reverse transcriptase polymerase chain reaction and Western blotting were used to assess fold gene and protein expression of extracellular membrane (ECM) proteins: collagen 1A (COL1A), fibronectin (FN1), and versican (VCAN) of the samples. Confirmatory immunohistochemical analysis was performed. Changes in total matrix collagen were examined using Masson trichrome staining. Multiplex measurement of the matrix metalloproteinases (MMPs) and tissue inhibitor of metalloproteinases was performed. Compared to placebo-treated surgical specimens, 80% of the treated specimens showed decrease in VCAN protein, 60% showed decrease in FN1, but no consistent alteration in COL1A. This effect was also supported by immunohistochemistry where leiomyoma surgical specimens demonstrated decreased amount of FN1 and VCAN on UPA treatment. Increased MMP2 and decreased MMP9 in treated patient leiomyomas indicate both degradation of the matrix and inhibition of the pathway involved in matrix production. Treatment with UPA decreased fibroid volume in placebo-controlled, randomized trials. Treatment with UPA decreased gene expression and protein production in leiomyoma tissue, suggesting both an impact on water content and ECM protein concentration as a mechanism of ulipristal-mediated decrease in leiomyoma size.

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Size, Type, and Location of Myoma as Predictors for Successful Laparoscopic Myomectomy: A Tertiary Government Hospital Experience.

Giornale Gynecology and minimally invasive therapy
Year 2018
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BACKGROUND: Laparoscopic myomectomy (LM) is a preferred alternative to abdominal myomectomy due to shorter hospitalization, faster recovery, and decreased intraoperative adhesions. The criteria, however, which constitute proper selection of patients for LM, are still a matter of debate. Since conversion to either laparoscopic-assisted myomectomy (LAM) or laparotomy (EL) entails longer time and increased costs compared to performing an open procedure from the outset, this research aims to evaluate size, location, and type of myoma as predictors for LM. METHODOLOGY: Inpatient medical records of all women who underwent LM from January 2014 to August 2016 were retrieved and reviewed. Demographic data, intraoperative records, and postoperative course were obtained. The association of size, type, and location of myomas to the procedure performed was analyzed. RESULTS: There was no significant association between the size of the myoma or its location to the procedure performed. However, intramural and subserous myomas were associated with successful LM, while submucous myomas were associated with conversion to either LAM or EL (P = 0.010). CONCLUSION: LM is a difficult procedure that challenges even the most skilled laparoscopic surgeon. Proper patient selection lessens complications and decreases the risk of conversion. In this study, type of myoma may be a good predictor for successful LM; however, this conclusion may be limited by the small sample size. A large-scale multicentric prospective study is necessary to validate the role of the proposed predictors to prevent unplanned conversion to an open procedure and reduce cost and increase safety of LM.

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Comparison of Long-Term Fertility Outcomes after Myomectomy: Relationship with Number of Myomas Removed.

Autori Shue S , Radeva M , Falcone T
Giornale Journal of minimally invasive gynecology
Year 2018
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STUDY OBJECTIVE: To determine if the number of myomas removed during myomectomy for symptomatic relief affects long-term fertility outcomes in reproductive-aged women. DESIGN: Retrospective cohort survey study (Canadian Task Force classification II-2). SETTING: University hospital. PATIENTS: One hundred forty-four patients who underwent myomectomy for symptomatic myomas and attempted to conceive afterward. INTERVENTION: Questionnaire mailed to reproductive-aged women who received robotic, laparoscopic, or abdominal myomectomy. MEASUREMENTS AND MAIN RESULTS: Patients with >6 myomas removed were less likely to achieve pregnancy after myomectomy than patients with ≤6 myomas removed (22.9% vs 70.8%, respectively; p < .001). To achieve pregnancy, 45% of those with >6 myomas removed (vs 17.6% of those with ≤6 myomas removed) relied on fertility treatment (clomiphene citrate, letrozole, intrauterine insemination, or in vitro fertilization). Of those with >6 myomas removed who became pregnant, 45.5% had a term birth, 45.5% miscarried, and 9.1% had an ectopic pregnancy. Of those with ≤6 myomas removed who became pregnant, 61.8% had a term birth, 23.5% had a preterm birth, and 13.2% miscarried. CONCLUSION: The number of myomas removed during myomectomy significantly affects fertility. Women with >6 myomas removed were less likely to become pregnant, more likely to require fertility treatment, and less likely to have a term birth when compared with women with ≤6 myomas removed.

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Complications in modern hysteroscopic myomectomy.

Giornale Ginekologia polska
Year 2018
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Uterine fibroids (UFs) are common benign tumors of the female genital tract, diagnosed in almost one-quarter of women of reproductive age. UFs may cause numerous clinical symptoms, including prolonged or heavy menstrual bleeding, pelvic pressure symptoms, pain, infertility and others. Submucous fibroids arise from the muscular part of the uterus and pen-etrate into the uterine cavity. They are mostly managed with the use of hysteroscopic myomectomy (HM), which provides direct visualization from the transcervical approach. The sheer number of HM standards and techniques is reason enough to review the available literature about HM-related complications. HM is a safe and effective treatment in patients with the normal size of the uterus and with no more than a few UFs. The procedure should not be initiated without adequate preparation and diagnosis, using the best methods available.

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Robot-assisted myomectomy.

Autori Lonnerfors C
Giornale Best practice & research. Clinical obstetrics & gynaecology
Year 2018
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Uterine fibroids are the most common tumors of the uterus and the female pelvis and are associated with substantial morbidity for several women. In women with a wish to preserve fertility, a myomectomy is the surgical procedure of choice when medical therapy is inadequate. Despite evidence that minimally invasive surgery is preferable to laparotomy, most myomectomies are still performed by laparotomy. Robotic surgery was introduced to overcome some of the difficulties associated with laparoscopic surgery. A myomectomy is a suture-intensive surgery where the properties of a surgical robot have been suggested to be of particular value. Robotic myomectomy is feasible and safe, with similar outcome to laparoscopic surgery, although a robotic procedure is associated with a higher cost. The introduction of robotic surgery has expanded the indications for minimally invasive myomectomy to more complex cases previously performed by laparotomy. Randomized trials comparing different approaches to myomectomy are yet to be published. More studies are needed to determine the patients in whom a robotic approach is most beneficial, both in terms of patient outcomes and cost efficiency.

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Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial.

Giornale Obstetrics and gynecology
Year 2018
Links Pubmed DOI PubMed Central

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OBJECTIVE: To assess efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas. METHODS: This phase 3, double-blind, placebo-controlled study enrolled premenopausal women (aged 18-50 years) with abnormal uterine bleeding, one or more discrete leiomyomas, and uterine size 20 weeks of gestation or less. Patients were randomized 1:1:1 to 5 mg ulipristal, 10 mg ulipristal, or placebo once daily for 12 weeks followed by 12-week drug-free follow-up. Coprimary endpoints were rate of and time to amenorrhea, defined as no bleeding for the last 35 consecutive days of treatment. Secondary endpoints included rates of amenorrhea from day 11 and change from baseline to endpoint in the Revised Activities subscale of the Uterine Fibroid Symptom and Quality of Life questionnaire, which includes questions pertaining to physical and social activities. Safety assessments included adverse event monitoring and endometrial biopsies. A sample size of 150 was planned to compare separately each dose of ulipristal with placebo. RESULTS: From March 2014 to March 2016, 157 patients were randomized. Demographics were similar across treatment groups. Amenorrhea was achieved by 25 of 53 (47.2% [97.5% CI 31.6-63.2]) and 28 of 48 (58.3% [97.5% CI 41.2-74.1]) patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 1 of 56 (1.8% [97.5% CI 0.0-10.9]) placebo-treated patients (both P<.001). Time to amenorrhea was shorter for both ulipristal doses compared with placebo (P<.001), and both doses of ulipristal resulted in improved quality of life compared with placebo (P<.001). Common adverse events (5% or greater in either ulipristal group during treatment) were hypertension, elevated blood creatinine phosphokinase, and hot flushes. Serious adverse events occurred in four patients, but none was considered related to treatment. Endometrial biopsies were benign. CONCLUSION: Ulipristal at 5 mg and 10 mg were well tolerated and superior to placebo in rate of and time to amenorrhea in women with symptomatic uterine leiomyomas. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov number, NCT02147197.

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Five-Year Lapsed: Review of Laparoscopic Myomectomy versus Open Myomectomy in Putrajaya Hospital.

Giornale Gynecology and minimally invasive therapy
Year 2018
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STUDY OBJECTIVE: This study aimed to investigate the morbidity of laparoscopic myomectomy (LM) versus open myomectomy (OM), including intraoperative blood loss, duration of surgery, hospital stay, and complications and to evaluate the criteria for selection of cases suitable for LM. DESIGN: This was a retrospective study. SETTING: This study was conducted at tertiary hospital. PARTICIPANTS: The records of 67 women who underwent LM, 22 women who underwent OM, and 14 women who had laparo-conversion from January 2010 to November 2014 were reviewed. MEASUREMENT AND MAIN RESULTS: Fibroids up to 10 cm were removed by LM, while most fibroids more than 10 cm were managed through OM. The number and weight of myomas are significantly associated with laparo-conversion, with a rate of 17%. Mean blood loss was significantly reduced in LM group than the OM and laparo-conversion groups. Duration of hospital stay was also significantly less in LM (2 ± 1 days) compared to both OM and laparo-conversion groups (3 ± 1 days). Most women underwent LM (88%) had no postoperative complications compared to OM (50%) and laparo-conversion (57.1%). The number of fibroids removed and duration of surgery was positively correlated with blood loss in the women who underwent myomectomy. CONCLUSION: LM is an ideal surgical approach for removal of fibroids which are up to 10 cm diameter and <5 in number, while OM is useful for cases with multiple (5 or more), larger fibroids (>10 cm), and deeply located fibroids. Preoperative evaluation of the size and number of myomas is necessary to avoid laparo-conversion and to reduce intraoperative and postoperative complications.

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Vaginal delivery outcomes of pregnancies following ultrasound-guided high-intensity focused ultrasound ablation treatment for uterine fibroids.

Autori Liu X , Xue L , Wang Y , Wang W , Tang J
Giornale International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group
Year 2018
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OBJECTIVE: To evaluate the feasibility and safety of vaginal delivery after ultrasound-guided high-intensity focused ultrasound (HIFU) ablation treatment for women with uterine fibroids of child-bearing ages. METHODS: A prospective study was conducted on women who underwent ultrasound-guided HIFU therapy for uterine fibroids at the Chinese PLA General Hospital from January 2008 to December 2014. Patients were interviewed yearly to assess their fertility outcomes, including conception method, delivery mode, neonatal outcomes and complications during pregnancy, labor, and delivery. RESULTS: A total of 174 patients with plans for future pregnancy were included, and 88 pregnancies in 81 women occurred. The pregnancy rate was 46.6% (81/174), and the median follow-up time was 76 months. The rate of pregnancies that ended in miscarriages was 10% (9/88), the rate of elective pregnancy termination was 6% (5/88), and 84% (74/88) of the pregnancies resulted in deliveries, with 3 of the 71 women having two deliveries. A cesarean section was requested by 50% (37/74) of the women, and 50% (37/74) opted for a vaginal delivery. Eleven of the 37 pregnancies were scheduled for elective cesarean sections, owing to pregnancy complications; the remaining 26 pregnancies were scheduled for vaginal delivery, and 21 (80.8%) were successful. None of the patients with a vaginal delivery experienced any complications during pregnancy and labor. CONCLUSIONS: Ultrasound-guided HIFU ablation could be considered a promising clinical treatment for women with uterine fibroids and plans for future pregnancy, and vaginal delivery after ultrasound-guided HIFU ablation treatment appear to be feasible and safe.

Primary study

Unclassified

Ulipristal acetate for treatment of uterine leiomyomas: A randomized controlled trial

Giornale Obstetrics and gynecology
Year 2018
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OBJECTIVE:To assess the efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas.METHODS:This phase 3, double-blind, double-dummy, placebo-controlled trial randomized premenopausal women (18-50 years) with uterine leiomyomas and abnormal uterine bleeding to once-daily 5 mg ulipristal, 10 mg ulipristal, or placebo in two 12-week treatment courses separated by a drug-free interval of two menses. Coprimary end points were rates of and time to amenorrhea during course 1. Change from baseline to end of course 1 in the Revised Activities subscale of the Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire was a secondary end point. A sample size of 400 was planned to compare separately each ulipristal dose with placebo.RESULTS:From January 2014 through November 2016, 432 women were randomized. Demographic characteristics were similar across treatment groups. In course 1, 68 of 162 (42.0% [97.5% CI 33.3-51.1]) and 86 of 157 (54.8% [97.5% CI 45.5-63.8]) patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 0 of 113 (0.0% [97.5% CI 0.0-3.8]) patients treated with placebo achieved amenorrhea (P<.001 for each dose); most women who achieved amenorrhea did so within 10 days (time to amenorrhea, P<.001 for each dose). Significantly greater improvements in Uterine Fibroid Symptom and Health-Related Quality of Life Revised Activities subscale scores were reported with 5 mg and 10 mg ulipristal compared with placebo (least squares mean change from baseline: 48.3, 56.7, and 13.0, respectively; P<.001 for each dose). Both ulipristal doses were well tolerated; in course 1, hot flush occurred in 7.5%, 11.6%, and 1.7% of patients treated with 5 mg ulipristal, 10 mg ulipristal, and placebo, respectively.CONCLUSION:Treatment with 5 mg or 10 mg ulipristal was superior to placebo in achieving amenorrhea and generally well tolerated for the medical management of symptomatic uterine leiomyomas.

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The Changes of Surgical Treatment for Symptomatic Uterine Myomas in the Past 15 Years.

Autori Yang W , Luo N , Ma L , Dai H , Cheng Z
Giornale Gynecology and minimally invasive therapy
Year 2018
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STUDY OBJECTIVE: The aim of this study is to elaborate the changes of the surgical approach of treatment for uterine myomas in Yangpu Hospital in the past 15 years. DESIGN: This was retrospective cohort study. SETTING: Yangpu Hospital, Tongji University School of Medicine, Shanghai, China. MATERIALS AND METHODS: A total of 4113 patients with symptomatic uterine myomas underwent surgical treatments. Interventions: Eight kinds of different surgeries were involved in the study, including abdominal or laparoscopic surgery, hysterectomy, or uterus-sparing myomectomy. MEASUREMENTS: The study collected patients' clinical data and reviewed surgical access and approach, complications, and the results of following up. RESULTS: A total of 1559 cases (37.9%) underwent uterus-sparing myomectomy, 3005 cases (73.1%) performed laparoscopic surgeries. The percentage of laparoscopic surgery was significantly higher than homochronous data of laparotomy after 2003 (P < 0.001). The per year total of uterus-reserved surgery was proved to be negatively correlated with patient's age (R2 = 0.930; P < 0.001). The rate of myomas recurrence was significantly lower in the combined myomectomy and uterine artery occlusion group (4%, 34/910) than in the single myomectomy group (10.5%, 44/420) (P < 0.001). CONCLUSIONS: Retaining uterus and minimally invasive surgery were the important trends of surgical treatment for symptomatic uterine myomas. Laparoscopic uterus-sparing myomectomy may be an alternative to hysterectomy to manage to appropriate patients with uterine myomas.