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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.

Primary study

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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 Wideochirurgia i inne techniki mało inwazyjne = Videosurgery and other miniinvasive techniques / kwartalnik pod patronatem Sekcji Wideochirurgii TChP oraz Sekcji Chirurgii Bariatrycznej TChP
Year 2013
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INTRODUZIONE: aderenze peritoneali, le bande fibrotiche che si formano tra le superfici in cavità peritoneale dopo l'intervento, rappresentano ancora una sfida clinica difficile. Obiettivo: valutare la SprayShield ™ Adhesion Barrier System (PEG soluzione estere ammina e una soluzione tampone) nel ridurre la formazione di aderenze post-operatoria. MATERIALI E METODI: Questo è stato uno studio prospettico, multicentrico, randomizzato, in singolo cieco. Un totale di 11 soggetti con diagnosi di colite ulcerosa (UC) o poliposi adenomatosa familiare (FAP) sono stati randomizzati: 8 al braccio SprayShield ™ e 3 per il braccio di controllo. SprayShield ™ è stato applicato sul visceri direttamente sotto l'incisione peritoneale linea mediana e nel sito di ileostomia. Durante l'intervento di follow-up, l'incidenza, estensione e gravità di formazione di aderenze post-operatoria sono stati valutati, nonché il tempo necessario per mobilizzare il ileale. RISULTATI: Nei pazienti che hanno ricevuto SprayShield ™ il tempo necessario per mobilitare l'ansa ileale alla chiusura ileostomia era leggermente più corto e l'incidenza e la gravità delle adesioni erano un po 'più basso rispetto al gruppo di controllo (NS). In conclusione, SprayShield ™ è stato trovato per essere facile da usare, sicuro e veloce da applicare, e buoni risultati in aderenza e conformità. L'incidenza e la gravità delle adesioni sono state inferiori per i soggetti SprayShield ™ contro soggetti di controllo, ma a causa del numero limitato di pazienti, non ci sono dati sufficienti per confermare l'efficacia del ™ Adhesion Barrier System SprayShield nella prevenzione delle adesioni.

Primary study

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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.

Primary study

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Giornale Annals of surgery
Year 2013
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OBIETTIVO: Valutare da prospettico studio randomizzato controllato la fattibilità e l'efficacia di utilizzo di un acido ialuronico / membrana carbossimetilcellulosa bioresorbable (membrana HA) per prevenire addominale e aderenze periepatico nei pazienti con carcinoma colorettale metastatico che necessitano di 2 stadi epatectomia. BACKGROUND: due stadi epatectomia offre la possibilità di sopravvivenza a lungo termine di pazienti selezionati le cui metastasi epatiche non possono essere rimossi in un unico procedimento. Tuttavia, la seconda operazione è resa più difficile da aderenze derivanti dalla prima. Membrana HA riduce aderenze in ginecologica e chirurgia addominale, ma questo è il primo studio a epatectomia. METODI: Cinquantaquattro candidati per 2 stadi epatectomia stati randomizzati al termine della prima procedura di impianto di membrana HA (n = 41) o gestione standard (n = 13). Trenta pazienti del braccio di membrana e 11 controlli ben abbinati sottoposti al secondo epatectomia previsto. RISULTATI: Posizionamento delle membrane HA era fattibile soltanto in uno paziente e non aumenta complicazioni associate con la prima epatectomia. In seconda epatectomia, i pazienti nel braccio della membrana HA richiesto 33% in meno tempo rispetto ai controlli per raggiungere una completa mobilitazione fegato (mediana: 50 vs 75 minuti; endpoint primario). Il rischio di estese aderenze è stata ridotta nel gruppo membrana HA (31% aveva grado 3-4 adesioni vs 55% nei controlli), così come lo era severity adesione (spessore 17% e adesioni ipervascolari vs 46%). La percentuale di pazienti con complicanze in seconda epatectomia era più alta nel gruppo di controllo (55% vs 23% nel gruppo membrana HA, p = 0,07). In conclusione, l'uso di 4 membrane HA alla fine della prima epatectomia ridotto la portata e la gravità delle aderenze e facilitato la seconda epatectomia nei pazienti con metastasi epatiche che hanno richiesto un epatectomia 2 stadi. Uno studio più ampio per confermare questi risultati è giustificata. (NCT01262417).

Primary study

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Autori Prasad S , Varun N , Kumar A
Giornale Fertility and Sterility
Year 2013
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