1.Preoperative Risk Factors for Pneumoperitoneal Conversion in Transumbilical Laparoscopic-Assisted Appendectomy With a Lifting Retractor for Acute Appendicitis
Atsushi SUGA ; Atsushi SEYAMA ; Takato NAKAJIMA ; Masaki OKAMOTO ; Koshiro UEDA ; Masanori HAYASHI ; Takashi INOUE ; Nobuki MATSUNAMI ; Tomoaki MORITA
Journal of the Japanese Association of Rural Medicine 2024;73(1):21-26
		                        		
		                        			
		                        			We use transumbilical laparoscopic-assisted appendectomy (TULAA) with a lifting retractor as the surgical technique of first choice for acute appendicitis. Although this technique provides excellent cosmetic results and contributes to reducing medical costs, it is less advantageous in difficult-to-complete cases that require conversion to pneumoperitoneum or additional ports. We retrospectively reviewed the records of 76 patients who underwent laparoscopic appendectomy between June 2020 and March 2023 (43 in a TULAA group and 33 in a pneumoperitoneal conversion group) to identify preoperative factors associated with pneumoperitoneal conversion. Univariate analysis showed significant differences for preoperative C-reactive protein (CRP) level, age, and body mass index. Logistic regression analysis identified preoperative CRP level and age as significant risk factors for pneumoperitoneal conversion. The pneumoperitoneal conversion rate was 12.5%, 48.2%, and 68% for patients with 0, 1, and 2 preoperative risk factors, respectively, indicating patients with 2 risk factors were more likely to undergo pneumoperitoneal conversion. These data may inform the selection of the surgical technique and the decision to convert to pneumoperitoneum.
		                        		
		                        		
		                        		
		                        	
2.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
		                        		
		                        			 Background:
		                        			Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy. 
		                        		
		                        			Methods
		                        			This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years. 
		                        		
		                        		
		                        		
		                        	
3.Cost-effectiveness analysis of hospital treatment volume and survival outcomes in endometrial cancer in Japan
Hiroko MACHIDA ; Koji MATSUO ; Takahiro HIGASHI ; Daisuke AOKI ; Takayuki ENOMOTO ; Aikou OKAMOTO ; Hidetaka KATABUCHI ; Satoru NAGASE ; Masaki MANDAI ; Nobuo YAEGASHI ; Wataru YAMAGAMI ; Mikio MIKAMI
Journal of Gynecologic Oncology 2024;35(5):e61-
		                        		
		                        			 Objective:
		                        			Hospital treatment volume affects survival in patients with endometrial cancer;notably, initial treatment at high-volume centers improves survival outcomes. Our study assessed the effect of hospital treatment volume on cost-effectiveness and survival outcomes in patients with endometrial cancer in Japan. 
		                        		
		                        			Methods:
		                        			A decision-analytic model was evaluated using the following variables and their impact on cost-effectiveness: 1) hospital treatment volume (low-, intermediate-, and highvolume centers) and 2) postoperative recurrent risk factors based on pathological findings (high- and intermediate-risk or low-risk). Data were obtained from the Japan Society of Obstetrics and Gynecology database, systematic literature searches, and the Japanese Diagnosis Procedure Combination database. Quality-adjusted life years (QALY) was used as a measure of effectiveness. The model was built from a public healthcare perspective and the impact of uncertainty was assessed using sensitivity analyses. 
		                        		
		                        			Results:
		                        			A base-case analysis showed that the incremental cost-effectiveness ratio at high-volume centers was below a willingness-to-pay (WTP) threshold of ¥5,000,000with a maximum of ¥3,777,830/4.28 QALY for the high- and intermediate-risk group, and ¥2,316,695/4.57 QALY for the low-risk group. Treatment at the high-volume centers showed better efficiency and cost-effectiveness in both strategies compared to intermediate- or lowvolume centers. Sensitivity analyses showed that the model outcome was robust to changes in input values. With the WTP threshold, treatment at high-volume centers remained cost-effective in at least 73.6% and 78.2% of iterations for high- and intermediate-risk, and lowrisk groups, respectively. 
		                        		
		                        			Conclusion
		                        			Treatment at high-volume centers is the most cost-effective strategy for guiding treatment centralization in patients with endometrial cancer. 
		                        		
		                        		
		                        		
		                        	
4.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
		                        		
		                        			 Background:
		                        			Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy. 
		                        		
		                        			Methods
		                        			This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years. 
		                        		
		                        		
		                        		
		                        	
5.Cost-effectiveness analysis of hospital treatment volume and survival outcomes in endometrial cancer in Japan
Hiroko MACHIDA ; Koji MATSUO ; Takahiro HIGASHI ; Daisuke AOKI ; Takayuki ENOMOTO ; Aikou OKAMOTO ; Hidetaka KATABUCHI ; Satoru NAGASE ; Masaki MANDAI ; Nobuo YAEGASHI ; Wataru YAMAGAMI ; Mikio MIKAMI
Journal of Gynecologic Oncology 2024;35(5):e61-
		                        		
		                        			 Objective:
		                        			Hospital treatment volume affects survival in patients with endometrial cancer;notably, initial treatment at high-volume centers improves survival outcomes. Our study assessed the effect of hospital treatment volume on cost-effectiveness and survival outcomes in patients with endometrial cancer in Japan. 
		                        		
		                        			Methods:
		                        			A decision-analytic model was evaluated using the following variables and their impact on cost-effectiveness: 1) hospital treatment volume (low-, intermediate-, and highvolume centers) and 2) postoperative recurrent risk factors based on pathological findings (high- and intermediate-risk or low-risk). Data were obtained from the Japan Society of Obstetrics and Gynecology database, systematic literature searches, and the Japanese Diagnosis Procedure Combination database. Quality-adjusted life years (QALY) was used as a measure of effectiveness. The model was built from a public healthcare perspective and the impact of uncertainty was assessed using sensitivity analyses. 
		                        		
		                        			Results:
		                        			A base-case analysis showed that the incremental cost-effectiveness ratio at high-volume centers was below a willingness-to-pay (WTP) threshold of ¥5,000,000with a maximum of ¥3,777,830/4.28 QALY for the high- and intermediate-risk group, and ¥2,316,695/4.57 QALY for the low-risk group. Treatment at the high-volume centers showed better efficiency and cost-effectiveness in both strategies compared to intermediate- or lowvolume centers. Sensitivity analyses showed that the model outcome was robust to changes in input values. With the WTP threshold, treatment at high-volume centers remained cost-effective in at least 73.6% and 78.2% of iterations for high- and intermediate-risk, and lowrisk groups, respectively. 
		                        		
		                        			Conclusion
		                        			Treatment at high-volume centers is the most cost-effective strategy for guiding treatment centralization in patients with endometrial cancer. 
		                        		
		                        		
		                        		
		                        	
6.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
		                        		
		                        			 Background:
		                        			Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy. 
		                        		
		                        			Methods
		                        			This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years. 
		                        		
		                        		
		                        		
		                        	
7.Cost-effectiveness analysis of hospital treatment volume and survival outcomes in endometrial cancer in Japan
Hiroko MACHIDA ; Koji MATSUO ; Takahiro HIGASHI ; Daisuke AOKI ; Takayuki ENOMOTO ; Aikou OKAMOTO ; Hidetaka KATABUCHI ; Satoru NAGASE ; Masaki MANDAI ; Nobuo YAEGASHI ; Wataru YAMAGAMI ; Mikio MIKAMI
Journal of Gynecologic Oncology 2024;35(5):e61-
		                        		
		                        			 Objective:
		                        			Hospital treatment volume affects survival in patients with endometrial cancer;notably, initial treatment at high-volume centers improves survival outcomes. Our study assessed the effect of hospital treatment volume on cost-effectiveness and survival outcomes in patients with endometrial cancer in Japan. 
		                        		
		                        			Methods:
		                        			A decision-analytic model was evaluated using the following variables and their impact on cost-effectiveness: 1) hospital treatment volume (low-, intermediate-, and highvolume centers) and 2) postoperative recurrent risk factors based on pathological findings (high- and intermediate-risk or low-risk). Data were obtained from the Japan Society of Obstetrics and Gynecology database, systematic literature searches, and the Japanese Diagnosis Procedure Combination database. Quality-adjusted life years (QALY) was used as a measure of effectiveness. The model was built from a public healthcare perspective and the impact of uncertainty was assessed using sensitivity analyses. 
		                        		
		                        			Results:
		                        			A base-case analysis showed that the incremental cost-effectiveness ratio at high-volume centers was below a willingness-to-pay (WTP) threshold of ¥5,000,000with a maximum of ¥3,777,830/4.28 QALY for the high- and intermediate-risk group, and ¥2,316,695/4.57 QALY for the low-risk group. Treatment at the high-volume centers showed better efficiency and cost-effectiveness in both strategies compared to intermediate- or lowvolume centers. Sensitivity analyses showed that the model outcome was robust to changes in input values. With the WTP threshold, treatment at high-volume centers remained cost-effective in at least 73.6% and 78.2% of iterations for high- and intermediate-risk, and lowrisk groups, respectively. 
		                        		
		                        			Conclusion
		                        			Treatment at high-volume centers is the most cost-effective strategy for guiding treatment centralization in patients with endometrial cancer. 
		                        		
		                        		
		                        		
		                        	
8.Association between Aortic Calcification Burden and the Severity of Erectile Dysfunction in Men Undergoing Dialysis: A Cross-Sectional Study
Naoki FUJITA ; Shingo HATAKEYAMA ; Masaki MOMOTA ; Yuki TOBISAWA ; Tohru YONEYAMA ; Teppei OKAMOTO ; Hayato YAMAMOTO ; Takahiro YONEYAMA ; Yasuhiro HASHIMOTO ; Kazuaki YOSHIKAWA ; Chikara OHYAMA
The World Journal of Men's Health 2023;41(2):373-381
		                        		
		                        			 Purpose:
		                        			Accelerated atherosclerosis is a major complication in patients with end-stage renal disease and it plays an important role in the pathogenesis of erectile dysfunction (ED). However, the association between aortic calcification burden and the severity of ED remains unclear. The aim of the present study was to investigate this association in men undergoing dialysis. 
		                        		
		                        			Materials and Methods:
		                        			This cross-sectional study included 71 men undergoing peritoneal dialysis and/or hemodialysis between July 2016 and May 2018 at Mutsu General Hospital. ED was assessed with the Sexual Health Inventory for Men (SHIM). Patients were divided into the mild/moderate (SHIM score ≥8) and severe ED groups (SHIM score ≤7). Aortic calcification index (ACI) was examined as a clinical indicator of abdominal aortic calcification. Multivariable logistic regression analysis was performed to identify the significant factors associated with severe ED. 
		                        		
		                        			Results:
		                        			The median age of the study participants was 64 years; all had ED, with 64.8% having severe ED. In the multivariable analyses, a slight association was observed between ankle-brachial index and severe ED (odds ratio [OR], 0.058; p=0.072), whereas ACI was significantly associated with severe ED (OR, 1.022; p=0.022). 
		                        		
		                        			Conclusions
		                        			Aortic calcification burden was independently associated with severe ED. 
		                        		
		                        		
		                        		
		                        	
9.Can Erectile Dysfunction Severity Predict Major Adverse Cardiovascular Events in Men Undergoing Dialysis? A Prospective Cohort Study
Naoki FUJITA ; Masaki MOMOTA ; Yusuke OZAKI ; Yuki TOBISAWA ; Tohru YONEYAMA ; Teppei OKAMOTO ; Hayato YAMAMOTO ; Shingo HATAKEYAMA ; Takahiro YONEYAMA ; Yasuhiro HASHIMOTO ; Kazuaki YOSHIKAWA ; Chikara OHYAMA
The World Journal of Men's Health 2023;41(4):900-908
		                        		
		                        			 Purpose:
		                        			To evaluate the impact of severe erectile dysfunction (ED) on future major adverse cardiovascular events (MACE) in men on dialysis. 
		                        		
		                        			Materials and Methods:
		                        			This prospective cohort study included 71 men on dialysis. ED was assessed using the Sexual Health Inventory for Men (SHIM). Men were divided into the mild/moderate ED (SHIM score ≥8) and severe ED (SHIM score ≤7) groups. The primary endpoint was MACE-free survival. MACE was a composite of myocardial infarction, cardiovascular death, and stroke. The secondary endpoints were cardiac event-free survival and overall survival (OS). Moreover, the predictive abilities of severe ED for 5-year MACE, 5-year cardiac events, and 5-year overall mortality were evaluated. 
		                        		
		                        			Results:
		                        			The median age and follow-up period of the included men were 64 years and 58 months, respectively. The median SHIM score was 4.0; all had a degree of ED, and 64.7% had severe ED. In the background-adjusted multivariable analyses, severe ED was not significantly associated with shorter MACE-free survival (hazard ratio [HR], 1.890; 95% confidence interval [CI], 0.533–6.706; p=0.324), cardiac event-free survival (HR, 2.081; 95% CI, 0.687–6.304; p=0.195), and OS (HR, 0.817; 95% CI, 0.358–1.863; p=0.630). Severe ED did not significantly improve the predictive abilities for 5-year MACE, 5-year cardiac events, and 5-year overall mortality (p=0.110, p=0.101, and p=0.740, respectively). 
		                        		
		                        			Conclusions
		                        			ED severity was not associated with shorter MACE-free survival, cardiac event-free survival, or OS, and ED severity could not improve the predictive abilities for these outcomes in men undergoing dialysis. 
		                        		
		                        		
		                        		
		                        	
10.An attempt to establish real-world databases of poly(ADP-ribose) polymerase inhibitors for advanced or recurrent epithelial ovarian cancer: the Japanese Gynecologic Oncology Group
Muneaki SHIMADA ; Kosuke YOSHIHARA ; Terumi TANIGAWA ; Hiroyuki NOMURA ; Junzo HAMANISHI ; Satoe FUJIWARA ; Hiroshi TANABE ; Hiroaki KAJIYAMA ; Masaki MANDAI ; Daisuke AOKI ; Takayuki ENOMOTO ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2023;34(3):e62-
		                        		
		                        			
		                        			 The development of new treatments for gynecological malignancies has been conducted mainly through collaborative international phase III trials led by the United States and Europe. The survival outcomes of many gynecological malignancies have greatly improved as a result. Recent large-scale genome-wide association studies have revealed that drug efficacy and adverse event profiles are not always uniform. Thus, it is important to validate new treatment options in each country to safely and efficiently provide newly developed treatment options to patients with gynecological malignancies. The Japanese Gynecologic Oncology Group (JGOG) is conducting 5 cohort studies (JGOG 3026, 3027, 3028, 3030, and 3031) to establish real-world data (RWD) of poly(ADP-ribose) polymerase (PARP) inhibitor use in patients with advanced or recurrent epithelial ovarian cancer. The RWD constructed will be used to provide newly developed PARP inhibitors for women with advanced or recurrent ovarian cancer in a safer and more efficient manner as well as to develop further treatment options. In 2022, The JGOG, Korean Gynecologic Oncology Group, Chinese Gynecologic Cancer Society, and Taiwanese Gynecologic Oncology Group established the East Asian Gynecologic Oncology Trial Group to collaborate with East Asian countries in clinical research on gynecologic malignancies and disseminate new knowledge on gynecologic malignancies from Asia. The JGOG will conduct a collaborative integrated analysis of the RWD generated from Asian countries and disseminate real-world clinical knowledge regarding new treatment options that have been clinically implemented. 
		                        		
		                        		
		                        		
		                        	
            

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