STUDY OBJECTIVE: To compare surgical experience at myomectomy between patients with myomas pretreated with ulipristal acetate versus no pretreatment.
DESIGN: A prospective, observational, multicenter study of myomectomy procedures by any route (hysteroscopic, laparoscopic, or laparotomy) (Canadian Task Force classification II-2).
SETTING: Five university-affiliated hospitals including tertiary care and community sites.
PATIENTS: Any patient who underwent hysteroscopic, laparotomic, or laparoscopic myomectomy regardless of medical pretreatment.
INTERVENTIONS: Surgeons completed a Web-based questionnaire after each myomectomy procedure. Surgeons evaluated visualization, the myoma-myometrium relationship, extrusion, fluid deficit, blood loss, and overall ease of hysteroscopic myomectomies. For laparotomic/laparoscopic myomectomies, plane delineation, myoma separation, blood loss, and overall ease were assessed. The total surgical experience score was calculated by summing the values for each subscale.
MEASUREMENTS AND MAIN RESULTS: A total of 309 myomectomies were evaluated by 52 surgeons (response rate = 83%) at 5 institutions. Of 140 hysteroscopic myomectomies, 84 (60%) were performed without pretreatment, 29 (21%) after ulipristal acetate pretreatment, and 27 (19%) after pretreatment with gonadotropin-releasing hormone agonist/other. Of 169 laparotomic/laparoscopic myomectomies, 104 (62%) were performed without pretreatment, 46 (27%) after ulipristal acetate, and 19 (11%) after gonadotropin-releasing hormone agonist/other. The mean surgical experience score (±standard deviation) was comparable between the no pretreatment and ulipristal acetate groups for hysteroscopic myomectomies (13.8 ± 2.2 vs 13.3 ± 2.2, p = .35) and laparotomic/laparoscopic myomectomies (12.9 ± 4.1 vs 12.1 ± 4.2, p = .30). Compared with no pretreatment, more laparotomic/laparoscopic myomectomies after ulipristal acetate pretreatment were associated with difficult delineation of surgical planes (22 [47.8%] vs 23 [22.1%], p = .002) and difficult myoma separation (20 [43.5%] vs 21 [20.2%], p = .003). More myomas were described as soft with ulipristal acetate pretreatment (14 [30.4%] vs 17 [16.4%], p = .049). The rates of profuse/abundant endometrium during hysteroscopy were similar between the no pretreatment (21 [25.0%]) and ulipristal acetate (7 [24.1%], p = .93) groups.
CONCLUSION: Despite differences in surgical nuances, the overall myomectomy experience was not negatively affected by ulipristal acetate pretreatment.
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.
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.
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.
STUDY OBJECTIVE: To evaluate the efficacy of preoperative treatment with ulipristal acetate (UPA) in patients undergoing high complexity hysteroscopic myomectomy.
DESIGN: Retrospective analysis of a prospectively collected database (Canadian Task Force classification II-2).
SETTING: University teaching hospital.
PATIENTS: Patients of reproductive age requiring hysteroscopic myomectomy with STEPW (size, topography, extension, penetration, and wall) score 5 or 6.
INTERVENTIONS: Patients included in the study either underwent direct surgery (group S) or received a 3-month preoperative treatment with UPA (group UPA). Based on a power calculation, 25 patients were required in each study group.
MEASUREMENTS AND MAIN RESULTS: Myoma characteristics were similar in the 2 study groups. The 3-month UPA treatment caused a 21.9% (±10.3%) mean (±SD) percentage decrease in myoma volume. The number of complete resections (primary outcome of the study) was higher in group UPA (92.0%) than in group S (68.0%; p = .034). The operative time was lower in group UPA than in group S (p = .048), whereas there was no significant difference in fluid balance between the 2 study groups (p = .256). The incidence of complications was similar in the 2 groups (p = .609). Patient satisfaction at 3 months from surgery was higher in group UPA than in group S (p = .041).
CONCLUSION: A 3-month preoperative treatment with UPA increases the possibility of complete resection in high complexity hysteroscopic myomectomy. It decreases the operative time and improves patient satisfaction at 3 months from surgery.
Ulipristal Acetate (UPA) modifies the endometrium, as well as fibroids, and therefore it might make hysteroscopic surgery more difficult. To confirm that pre-treatment with UPA is as safe and effective an option as pre-treatment with GnRH analogues, considered the gold standard. We present the first series of 26 hysteroscopic myomectomies after 3 months treatment with UPA and we compare the results with a series of 24 cases pretreated with GnRH analogues. This was a retrospective cohort study between July 2013 and May 2015. We analyszed patients with submucous myomas >2.5 in diameter. Hysteroscopic myomectomy was performed after 3 months of treatment with either UPA (5mg daily) or the GnRH agonist (3.75mg/month). Both groups were similar in age, myoma initial size and classification. There were no significant differences between UPA and GnRHa treated groups in terms of percentage of myomas resected (93% vs 98%), duration of surgery (38 vs 37min), fluid deficit (200 vs 350ml) and complications. In the surgeon's subjective opinion, UPA treatment was associated with an easier resection. Based on our experience, previous treatment with UPA does not difficult Hhysteroscopic myomectomy. Endometrial changes have no impact on surgery. Safety and feasibility are comparable to hysteroscopic myomectomies with previous treatment with GnRH analogues. This allows us to take advantage of the reduction in size of fibroids before surgery with less side effects.
OBJECTIVE: To compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas.
STUDY DESIGN: Single center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35 mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75 mg every 28 days; group T; n=20), letrozole (2.5 mg/day; group L; n=11) or ulipristal acetate (5 mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas.
RESULTS: All medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005).
CONCLUSIONS: Preoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas.
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.
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.
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.
To compare surgical experience at myomectomy between patients with myomas pretreated with ulipristal acetate versus no pretreatment.
DESIGN:
A prospective, observational, multicenter study of myomectomy procedures by any route (hysteroscopic, laparoscopic, or laparotomy) (Canadian Task Force classification II-2).
SETTING:
Five university-affiliated hospitals including tertiary care and community sites.
PATIENTS:
Any patient who underwent hysteroscopic, laparotomic, or laparoscopic myomectomy regardless of medical pretreatment.
INTERVENTIONS:
Surgeons completed a Web-based questionnaire after each myomectomy procedure. Surgeons evaluated visualization, the myoma-myometrium relationship, extrusion, fluid deficit, blood loss, and overall ease of hysteroscopic myomectomies. For laparotomic/laparoscopic myomectomies, plane delineation, myoma separation, blood loss, and overall ease were assessed. The total surgical experience score was calculated by summing the values for each subscale.
MEASUREMENTS AND MAIN RESULTS:
A total of 309 myomectomies were evaluated by 52 surgeons (response rate = 83%) at 5 institutions. Of 140 hysteroscopic myomectomies, 84 (60%) were performed without pretreatment, 29 (21%) after ulipristal acetate pretreatment, and 27 (19%) after pretreatment with gonadotropin-releasing hormone agonist/other. Of 169 laparotomic/laparoscopic myomectomies, 104 (62%) were performed without pretreatment, 46 (27%) after ulipristal acetate, and 19 (11%) after gonadotropin-releasing hormone agonist/other. The mean surgical experience score (±standard deviation) was comparable between the no pretreatment and ulipristal acetate groups for hysteroscopic myomectomies (13.8 ± 2.2 vs 13.3 ± 2.2, p = .35) and laparotomic/laparoscopic myomectomies (12.9 ± 4.1 vs 12.1 ± 4.2, p = .30). Compared with no pretreatment, more laparotomic/laparoscopic myomectomies after ulipristal acetate pretreatment were associated with difficult delineation of surgical planes (22 [47.8%] vs 23 [22.1%], p = .002) and difficult myoma separation (20 [43.5%] vs 21 [20.2%], p = .003). More myomas were described as soft with ulipristal acetate pretreatment (14 [30.4%] vs 17 [16.4%], p = .049). The rates of profuse/abundant endometrium during hysteroscopy were similar between the no pretreatment (21 [25.0%]) and ulipristal acetate (7 [24.1%], p = .93) groups.
CONCLUSION:
Despite differences in surgical nuances, the overall myomectomy experience was not negatively affected by ulipristal acetate pretreatment.
