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Background: ArtiSential, a class of innovative laparoscopic instrument, has been developed to overcome the limitations of conventional laparoscopic surgery by enabling free, 360°-unrestricted movement of the wrist joint, as in robotic surgery., Objective: The aim of the present study was to describe the initial experiences with these devices in myomectomy and to report the surgical outcomes., Methods: A total of 77 women undergoing laparoscopic or robotic myomectomy between January 2021 and June 2022 were included in this multicenter prospective study. The ArtiSential instruments used by the surgeons were those chosen according to their respective preferences. The baseline characteristics, surgical outcomes, trocar placement options, and operator survey results were scrutinized., Results: The mean age of the patients was 39.9 ± 6.3, and the mean body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) was 22.4 ± 3.4 kg/m 2 ; 46.8% of the patients underwent robotic surgery, while 53.2% underwent laparoscopic surgery. The number of removed myomas was 3.3 ± 3.0, the size of the largest myoma was 7.1 ± 2.3 cm, and the operative time was 130.0 ± 54.0 min. No transfusions or laparotomy conversions were required. Other than one case of ileus, there were no postoperative complications. In most cases, the instruments were inserted through the umbilicus trocar, and the fenestrated forceps, needle holder, and bipolar fenestrated forceps, in that order, were frequently employed. According to a surgeon survey, 29.9% moderately or strongly agreed that the ArtiSential devices utilized were more convenient than conventional laparoscopic instruments, while only 9.7% moderately or strongly agreed that they were more convenient than robotic instruments., Conclusions: Myomectomy as performed with an ArtiSential instrument seems to be feasible and safe. Further studies are necessary in order to comparatively assess the outcomes and potential benefits of ArtiSential, robotic, and conventional laparoscopic myomectomy., (© 2024 International Federation of Gynecology and Obstetrics.)

Raloxifene hydrochloride shows poor bioavailability (only 2%) when orally administered because of its poor aqueous solubility and its extensive first-pass metabolism. A new micronized formulation of raloxifene was developed to improve bioavailability via enhanced gastrointestinal absorption. The primary objective of this study was to evaluate the pharmacokinetic characteristics of a new micronized raloxifene formulation (AD-101) in comparison with the conventional raloxifene formulation. This study was designed as an open-label, randomized, 2-treatment-period, crossover study with a 2-week washout period. Two treatments consisted of micronized raloxifene 45 mg daily; and conventional raloxifene 60 mg daily administered in fasting conditions. Plasma raloxifene concentrations were determined by a validated method using ultra-fast liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters were calculated using a noncompartmental model. In total, 49 subjects completed the study. The geometric mean ratio (micronized/conventional) of the maximum concentration and the area under the plasma concentration-time curve from time zero to the last concentration values were 1.08 (90% CI, 0.95-1.24) and 0.97 (90% CI, 0.89-1.05), respectively. The adverse event profile did not differ between the 2 formulations. The results demonstrate that micronized formulation of raloxifene 45 mg is equivalent to conventional formulation of raloxifene 60 mg when administered at the single dose in the fasted state. After single oral dosing of AD-101, there were no serious or unexpected adverse events., (© 2023 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)

Osteoporosis is a common skeletal disorder, often leading to fragility fracture. Combination therapy with raloxifene, a selective estrogen receptor modulator, and cholecalciferol (vitamin D 3 ) has been proposed to improve the overall efficacy and increase compliance of raloxifene therapy for postmenopausal osteoporosis. To our knowledge, there has been no report of any study on the pharmacokinetic interaction between raloxifene and cholecalciferol. This study aimed to evaluate the possible pharmacokinetic interactions between raloxifene and cholecalciferol in healthy adult male Korean volunteers. Twenty subjects completed this open-label, randomized, single-dose, 3-period, 6-sequence, crossover phase 1 study with a 14-day washout period. Serial blood samples were collected from 20 hours before dosing to 96 hours after dosing. The plasma concentrations of raloxifene and cholecalciferol were determined using a validated method for high-performance liquid chromatography with tandem mass spectrometry. The geometric mean ratios (90%CIs) for area under the plasma concentration-time curve from time 0 to the last quantifiable time point and maximum plasma concentration of raloxifene with or without cholecalciferol were 1.02 (0.87-1.20) and 0.87 (0.70-1.08), respectively. For baseline-corrected cholecalciferol, geometric mean ratios (90%CIs) of area under the plasma concentration-time curve from time 0 to the last quantifiable time point and maximum plasma concentration with or without raloxifene were 1.01 (0.93-1.09) and 0.99 (0.92-1.06), respectively. Concurrent treatment with raloxifene and cholecalciferol was generally well tolerated. These results suggest that raloxifene and cholecalciferol have no clinically relevant pharmacokinetic drug-drug interactions when administered concurrently. All treatments were well tolerated, with no serious adverse events., (© 2022 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)

Background: We hypothesized that the total operative time of robot myomectomy (RM) is shorter than that of laparoscopic myomectomy (LM) in cases where numerous myomas are removed, due to the faster suturing time of the robotic system. To verify this, we compared the surgical outcomes of RM vs LM for the number of myomas removed., Methods: The medical records of 144 women underwent LM and 121 women underwent RM by a single surgeon were reviewed., Results: The operative time did not statistically differ between the groups, even when the number of removed myomas was more than 12 (200.6 ± 48.2 vs 196.0 ± 48.4 minutes, P = .791). Note that in our logistic regression analysis, the operation type was excluded from the independent risk factors prolonging operative time., Conclusion: RM showed a similar operative time relative to LM regardless of the number of myomas removed (numerous or not)., (© 2020 John Wiley & Sons, Ltd.)

Background: To introduce a hybrid robotic single-site myomectomy (H-RSSM) technique that includes laparoscopic single-site myoma excision followed by robotic single-site suture and compare its surgical outcomes with those of conventional robotic single-site myomectomy (RSSM) using the da Vinci Si surgical system., Methods: Medical records of 89 consecutive women who underwent H-RSSM and 131 consecutive women who underwent RSSM were retrospectively reviewed. Patients characteristics and surgical outcomes were evaluated and compared between two groups., Results: The H-RSSM group had a significantly reduced operation time (98.7 ± 31.7 vs 141.4 ± 54.4 min, P < .001) and lower estimated blood loss (131.5 ± 78.1 vs 212.3 ± 189.8 mL, P < .001). Peritoneal adhesions were reported significantly more in the H-RSSM group than in the RSSM group (27.0% vs 9.2%, P < .001)., Conclusion: H-RSSM was found to be associated with reduced operative time and lower estimated blood loss. However, further prospective studies are needed to clarify these advantages., (© 2019 John Wiley & Sons, Ltd.)

Background: To evaluate the feasibility and clinical outcomes of robotic single-site myomectomy (RSSM) for uterine myoma., Methods: Medical records of 101 consecutive women who underwent RSSM were retrospectively reviewed, and patient characteristics and surgical outcomes were evaluated. The surgical outcomes were compared by the phase in learning curve (early phase of <10 cases vs late phase of ≥10 cases) and time flow., Results: A total of 47 (46.5%) women had multiple myomas, and a median two (1-12) myomas were retrieved. The largest myoma was averagely measured as 6.2 ± 1.7 cm, and the mean weight of the total retrieved myomas was 114.0 ± 84.4 g. No patients received a transfusion or had operation-related complications. Cases in the late phase showed shorter port placement time and docking time than those in the early phase., Conclusions: Our data suggest that robotic single-site surgery is a feasible therapeutic option for uterine myoma., (© 2018 John Wiley & Sons, Ltd.)

Background: Previously proposed criteria for preoperatively identifying endometrial cancer patients at low risk for lymph node metastasis remain to be verified. For this purpose, a prospective, multicenter observational study was performed., Methods: Eligible patients with histologically confirmed endometrial cancer underwent magnetic resonance imaging (MRI) and serum cancer antigen 125 (CA 125) testing before surgery. The following criteria were used to identify low-risk patients: 1) endometrioid-type cancer, 2) no evidence of deep myometrial invasion on MRI, 3) no enlarged lymph nodes on MRI, 4) no suspicious metastasis out of the uterine corpus, and 5) serum CA 125 levels less than 35 U/mL. Systematic pelvic and/or para-aortic lymphadenectomy was performed for all patients. The primary endpoint was estimation of the negative predictive value (NPV)., Results: From January 2012 to December 2014, 529 patients from 20 hospitals in 3 Asian countries were consecutively enrolled. According to our criteria, 272 patients (51.4%) were categorized into the low-risk group. Fifty-three of the 529 patients (10.0%) had lymph node metastases; these patients included 8 (2.9%) falsely categorized as low-risk. The sensitivity and specificity of the criteria were 84.9% and 55.5%, respectively. The NPV of 97.1% was higher than the predefined target endpoint of 96%., Conclusions: The low-risk criteria based on preoperative tests were confirmed to be reliable and accurate for identifying patients at low risk for lymph node metastasis. These criteria may facilitate patient counseling and surgical decision making. Cancer 2017;123:263-272. © 2016 American Cancer Society., (© 2016 American Cancer Society.)

Objective: To evaluate the cumulative recurrence rates of ovarian endometrioma among patients using a levonorgestrel-releasing intrauterine system (LNG-IUS) after conservative laparoscopic surgery., Methods: A retrospective review was conducted of premenopausal women who underwent conservative laparoscopic surgery for ovarian endometrioma and subsequent treatment with LNG-IUS at two gynecologic surgery centers in South Korea between January 1, 2007, and September 30, 2014. Eligible patients had no residual ovarian lesions before LNG-IUS insertion, underwent insertion within 12 months of primary surgery, and were followed up for at least 6 months afterwards. Recurrence was defined as a cystic mass (≥2 cm in diameter) detected by transvaginal ultrasonography., Results: Overall, 61 patients were included. The mean duration of follow-up was 42.9 ± 22.0 months (range 8-98). Recurrence of ovarian endometrioma was detected among 7 (11%) of the patients. On Kaplan-Meier analysis, the cumulative recurrence rates were 4.0%, 6.3%, and 25.5% at 24, 36, and 60 months after surgery, respectively. In multivariate analysis, nulliparity at surgery was the only risk factor for recurrence (hazard ratio 5.892, 95% confidence interval 1.139-30.484; P=0.034)., Conclusion: Long-term maintenance therapy with LNG-IUS after conservative surgery might be a treatment option to consider to prevent ovarian endometrioma recurrence among premenopausal women., (Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Population pharmacokinetic (PK) and pharmacodynamic (PD) modeling of clopidogrel was developed from pooled data from healthy volunteers (n = 44) and stroke patients (n = 35). The PK modeling used plasma concentrations of the clopidogrel metabolite (SR26334), and the PD modeling used platelet aggregation. The models were developed using NONMEM and evaluated via visual predictive check (VPC). Data were analyzed by 2-compartment modeling with Erlang's absorption and first-order elimination. There was no statistically significant covariate for each model parameter. The typical point estimates of PK were k(tr) (identical transfer rate constant) = 5.97 h(-1), k(e) (elimination rate constant) = 0.126 h(-1), k(d) (distribution rate constant) = 0.212 h(-1), V(2) (volume of central compartment) = 21.0 L, and V(3) (volume of peripheral compartment) = 38.8 L. The typical point estimates of PD were k(in) (input rate) = 27.9 h(-1), E(max) (maximum effect on input rate) = 0.292 h(-1), EC(5) (0) (median effective concentration) = 0.00629 ng/mL, and BASE (predose aggregation) = 66.7%. The final model was used to estimate individual parameters using patient data and showed good predictions using VPC.