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Low-Dose Mifepristone Versus Placebo to Treat Uterine Myoma: A Double-Blind, Randomized Clinical Trial
Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S253
S91
Surgeon’s heart rate at different phases of the srugery in correlation with the opertive time Patients
HR-RPA- Right para aortic LND
HR-LPA (Left para aortic LND)
Operative time for PA
HR-PL (Pelvic LND)
Operative time for PL
1-10 11-20 21-30 31-41 p value
105 96 85 76 0.001
92 76 71 70 0.02
76 min
73 72 69 67 0.02
59 min
56 min 0.03
There was a statistically significant difference between the first 10 cases and cases 21-30 (p=0.001) and cases 31-42 (p=0.001). Decreasing surgeon’s heart rate correlates with decreasing operative time (76 vs. 56 minutes p=0.03). For the LPA, The HR was 92 bpm for the first 10 cases, 76 bpm for cases 11-20, 71 bpm for cases 21-30, and 70 bpm for cases 31-42 (p=0.02). The mean heart rate for PL for the first 10 cases was 72.9 bpm, 71.5 bpm for cases 11-20, 68.6 bpm for cases 21-30, and 66.6 bpm for cases 31-42.There was a statically significant difference between the first 10 cases and cases 31-42 (p=0.02), this correlated with shortening of the operative time (59 vs. 39 minutes p=0.01). The heart rates were not different in the hysterectomy part of the surgeries. Conclusion: Heart rate measurements may serve as a surrogate marker for surgeon’s mastery of a novel or challenging surgical skill.
232 Low-Dose Mifepristone Versus Placebo to Treat Uterine Myoma: A Double-Blind, Randomized Clinical Trial Liu C. Obstetrics and Gynecology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China Study Objective: To evaluate the efficacy and safety of 10 mg mifepristone per day compared with a placebo in treating uterine fibroids. Design: Randomized, double-blind,placebo-control clinical study. Setting: Department Gyn./Obs.,Beijing Chaoyang Hospital, Affiliated with Capital Medical University. Patients: One hundred thirty-two subjects with symptomatic uterine fibroids Intervention: One daily pill of 10 mg mifepristone or a mifepristone placebo over 3 months. Measurements and Main Results: Three months into treatment, Geometry mean of fibroid volume variable rate and 95% confidence interval were –25.92(d34.95wd15.63)%in the mifepristone group and –1.98(d13.06wd11.63)% in the placebo group (P \0.05).The difference value of geometry mean of the largest fibroid volume variable rate and 95% confidence interval between the groups were –33.64(d60.00wd11.63)%. This meant that fibroid volume was reduced by 33.64% in the mifepristone group than in the placebo group.After treatment, Hb mean value was increased 7.81g/l in the mifepristone group, and no changes in the plcebo group.There were no difference in liver function between groups.FSH level were also no changes. Conclusion: The 10 mg dosage of mifepristone presented significantly superior efficacy com:pared to the placebo and also was safe in treating uterine fibroids.
233 Metabolic Syndrome: Predictive Factor for Endometrial Polyps in Postmenopausal Women Bueloni-Dias FN,1 Spadoto-Dias D,1 Nahas EAP,1 Nahas-Neto J,1 Modotti WP,2 Dias R.1 1Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University - FMB/UNESP, Botucatu SP, Sao
39 min 0.01
HR (Hyst) 68 68 68 66 NS
operative time for Hyst 76 min 62 min NS
Paulo, Brazil; 2Instituto de Atendimento Medico-Hospitalar - IAM, Assis SP, Sao Paulo, Brazil Study Objective: To evaluate the clinical predictive factors of endometrial polyps in postmenopausal women. Design: Cross-sectional study. Setting: Tertiary public hospital, university teaching center. Patients: One hundred thirty-two women with histopathologic diagnosis of endometrial polyp were compared with 264 patients without endometrial alterations (control). In the study were included women with amenorrhea R 12 months and age R 45 years, in a proportion of 1 case to 2 controls. Intervention: Clinical, anthropometric, laboratory and ultrasonographic data were collected from medical records to evaluate the predictive factors of endometrial polyps. For statistical analysis were used the Student-t, chi-square tests and logistic regression method (odds ratioOR). Measurements and Main Results: Patients with endometrial polyps were older and had more time since menopause when compared to control (P \.0001). A higher percentage of women with endometrial polyps were obese (72%) compared to control (39%) (P \.0001). The measurement of waist circumference was higher among patients with polyps (P = 0.0001). We observed a higher incidence of diabetes, hypertension and dyslipidemia in patients with endometrial polyps (P \.0001). According to the NCEP/ATP III, 48.5% of women with polyps and 33.3% in the control group were classified as having metabolic syndrome (P = 0.004). Analysis of risk for endometrial polyp formation was higher in patients with: BMI R 25 kg/m2 (OR 4.66; CI 95% 2.16-10.05); glucose R 100 mg/dl (OR 2.83; CI 95% 1.36-5.90); dyslipidemia (OR 7.02; CI 95% 3.70-13.32); diabetes (OR 2.58; CI 95% 1.05-6.32); and metabolic syndrome (OR 2.76; CI 95% 1.18-6.46). (P = 0.019) compared to control. Conclusion: In postmenopausal women, obesity, dyslipidemia, hyperglycemia and the presence of metabolic syndrome were predictive factors for endometrial polyp.
234
Open Communications 19 - Laparoscopy (2:15 PM - 3:15 PM)
Single Institutional Experience of 410 Cases of Type B & Type C (Querleu Morrow Classification) Laparoscopic Radical Hysterectomy Puntambekar SP, Sugoor D, Joshi G, Puntambekar SP, kumbhare S, Sharma V, Parikh H. Minimally Inasive and Laparoscopic Oncosurgery, Galaxy Care Laparoscopy Institute, Pune, Maharashtra, India Study Objective: To describe our 12 years experience in type B and C laparoscopic radical hysterectomy. Design: Retrospective cohort study. Setting: Galaxy Care Laparoscopy Institute, Pune, India. Patients: 410 cases of cervical and endometrial cancer were operated between September 2002 to December 2014. All cases of cervical cancer of International Federation of Gynecology and Obstetrics (FIGO) stage IA1(n=220), IA2(n=22), IB1(n=28), IB2(n=33), IIA1(n=29), IIA2(n=11) and all cases of carcinoma of endometrium of FIGO Stage II(n=61), III(n=6) were included. All underwent Laparoscopic radical hysterectomy by Pune technique.
S91
Surgeon’s heart rate at different phases of the srugery in correlation with the opertive time Patients
HR-RPA- Right para aortic LND
HR-LPA (Left para aortic LND)
Operative time for PA
HR-PL (Pelvic LND)
Operative time for PL
1-10 11-20 21-30 31-41 p value
105 96 85 76 0.001
92 76 71 70 0.02
76 min
73 72 69 67 0.02
59 min
56 min 0.03
There was a statistically significant difference between the first 10 cases and cases 21-30 (p=0.001) and cases 31-42 (p=0.001). Decreasing surgeon’s heart rate correlates with decreasing operative time (76 vs. 56 minutes p=0.03). For the LPA, The HR was 92 bpm for the first 10 cases, 76 bpm for cases 11-20, 71 bpm for cases 21-30, and 70 bpm for cases 31-42 (p=0.02). The mean heart rate for PL for the first 10 cases was 72.9 bpm, 71.5 bpm for cases 11-20, 68.6 bpm for cases 21-30, and 66.6 bpm for cases 31-42.There was a statically significant difference between the first 10 cases and cases 31-42 (p=0.02), this correlated with shortening of the operative time (59 vs. 39 minutes p=0.01). The heart rates were not different in the hysterectomy part of the surgeries. Conclusion: Heart rate measurements may serve as a surrogate marker for surgeon’s mastery of a novel or challenging surgical skill.
232 Low-Dose Mifepristone Versus Placebo to Treat Uterine Myoma: A Double-Blind, Randomized Clinical Trial Liu C. Obstetrics and Gynecology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China Study Objective: To evaluate the efficacy and safety of 10 mg mifepristone per day compared with a placebo in treating uterine fibroids. Design: Randomized, double-blind,placebo-control clinical study. Setting: Department Gyn./Obs.,Beijing Chaoyang Hospital, Affiliated with Capital Medical University. Patients: One hundred thirty-two subjects with symptomatic uterine fibroids Intervention: One daily pill of 10 mg mifepristone or a mifepristone placebo over 3 months. Measurements and Main Results: Three months into treatment, Geometry mean of fibroid volume variable rate and 95% confidence interval were –25.92(d34.95wd15.63)%in the mifepristone group and –1.98(d13.06wd11.63)% in the placebo group (P \0.05).The difference value of geometry mean of the largest fibroid volume variable rate and 95% confidence interval between the groups were –33.64(d60.00wd11.63)%. This meant that fibroid volume was reduced by 33.64% in the mifepristone group than in the placebo group.After treatment, Hb mean value was increased 7.81g/l in the mifepristone group, and no changes in the plcebo group.There were no difference in liver function between groups.FSH level were also no changes. Conclusion: The 10 mg dosage of mifepristone presented significantly superior efficacy com:pared to the placebo and also was safe in treating uterine fibroids.
233 Metabolic Syndrome: Predictive Factor for Endometrial Polyps in Postmenopausal Women Bueloni-Dias FN,1 Spadoto-Dias D,1 Nahas EAP,1 Nahas-Neto J,1 Modotti WP,2 Dias R.1 1Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University - FMB/UNESP, Botucatu SP, Sao
39 min 0.01
HR (Hyst) 68 68 68 66 NS
operative time for Hyst 76 min 62 min NS
Paulo, Brazil; 2Instituto de Atendimento Medico-Hospitalar - IAM, Assis SP, Sao Paulo, Brazil Study Objective: To evaluate the clinical predictive factors of endometrial polyps in postmenopausal women. Design: Cross-sectional study. Setting: Tertiary public hospital, university teaching center. Patients: One hundred thirty-two women with histopathologic diagnosis of endometrial polyp were compared with 264 patients without endometrial alterations (control). In the study were included women with amenorrhea R 12 months and age R 45 years, in a proportion of 1 case to 2 controls. Intervention: Clinical, anthropometric, laboratory and ultrasonographic data were collected from medical records to evaluate the predictive factors of endometrial polyps. For statistical analysis were used the Student-t, chi-square tests and logistic regression method (odds ratioOR). Measurements and Main Results: Patients with endometrial polyps were older and had more time since menopause when compared to control (P \.0001). A higher percentage of women with endometrial polyps were obese (72%) compared to control (39%) (P \.0001). The measurement of waist circumference was higher among patients with polyps (P = 0.0001). We observed a higher incidence of diabetes, hypertension and dyslipidemia in patients with endometrial polyps (P \.0001). According to the NCEP/ATP III, 48.5% of women with polyps and 33.3% in the control group were classified as having metabolic syndrome (P = 0.004). Analysis of risk for endometrial polyp formation was higher in patients with: BMI R 25 kg/m2 (OR 4.66; CI 95% 2.16-10.05); glucose R 100 mg/dl (OR 2.83; CI 95% 1.36-5.90); dyslipidemia (OR 7.02; CI 95% 3.70-13.32); diabetes (OR 2.58; CI 95% 1.05-6.32); and metabolic syndrome (OR 2.76; CI 95% 1.18-6.46). (P = 0.019) compared to control. Conclusion: In postmenopausal women, obesity, dyslipidemia, hyperglycemia and the presence of metabolic syndrome were predictive factors for endometrial polyp.
234
Open Communications 19 - Laparoscopy (2:15 PM - 3:15 PM)
Single Institutional Experience of 410 Cases of Type B & Type C (Querleu Morrow Classification) Laparoscopic Radical Hysterectomy Puntambekar SP, Sugoor D, Joshi G, Puntambekar SP, kumbhare S, Sharma V, Parikh H. Minimally Inasive and Laparoscopic Oncosurgery, Galaxy Care Laparoscopy Institute, Pune, Maharashtra, India Study Objective: To describe our 12 years experience in type B and C laparoscopic radical hysterectomy. Design: Retrospective cohort study. Setting: Galaxy Care Laparoscopy Institute, Pune, India. Patients: 410 cases of cervical and endometrial cancer were operated between September 2002 to December 2014. All cases of cervical cancer of International Federation of Gynecology and Obstetrics (FIGO) stage IA1(n=220), IA2(n=22), IB1(n=28), IB2(n=33), IIA1(n=29), IIA2(n=11) and all cases of carcinoma of endometrium of FIGO Stage II(n=61), III(n=6) were included. All underwent Laparoscopic radical hysterectomy by Pune technique.