- Email: [email protected]
Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Myomas and Laparoscopic Myomectomy (LM): Clinical Outcomes at Three Years from a Randomized Trial of Uterine-Sparing Techniques
S40
Abstracts / Journal of Minimally Invasive Gynecology 23 (2016) S1–S252
Table 1 Enseal (n = 70) Mean +/- Std Dev (%) Baseline Covariates Age BMI (kg/m2) Parity Prior laparoscopies Prior laparotomies Uterine weight (grams) Study Objectives RTLX average T1 (minutes) EBL (mL) Any complications Device failures
Median (IQR)
41.6 +/- 6.9 35.6 +/- 10.1
Ligasure (n = 70) Mean +/- Std Dev (%)
Test for Difference Median (IQR)
41.3 +/- 7.7 34.3 +/- 9.1 2 1 0 165
(1-3) (0-1) (0-1) (11.5-289.8)
51.7 (39.6-59) 35 (25-48) 100 (50-200)
(n=69) 1 (1.4%) 10 (14.3%)
T-test Chi square
0.8356 0.4211 2 1 0 148.7
(1-3) (0-2) (0-1) (84.2-261.5)
0.3445 0.1345 0.2117 0.3445
\0.0001 0.0281 0.5823
32.5 (17.7-48.1) 30 (22-40.8) 100 (50-150)
(n=70)
Mann-Whitney U-test
2 (2.9%) 0 (0%)
1.0000 0.0031
Statistically-significant differences in higher RTLX scores (p=[lt]0.0001) and device failures (p=0.0031) for the articulating device. Noted longer time to ligation of the bilateral uterine arteries (p=0.0281) for the articulating device. Table 2
Intercept Enseal device T1 Device failures Uterine weight BMI
Coefficient
LCI
UCI
p-value
13.13 15.04 0.23 2.18 0.011 0.29
8.83 0.04 -9.87 0.000 -0.02
21.25 0.42 14.23 0.023 0.6
\0.0001 0.0191 0.7215 0.0485 0.0669
RTLX = raw Task Load Index. LCI = lower-end confidence interval. UCI = upper-end confidence interval. T1 = time to ligation of bilateral uterine arteries. BMI = body mass index. No significant differences seen in EBL or additional costs. Multivariate regression analysis of average RTLX score revealed statistically-significant differences in articulating device (p=\0.0001) and T1 (p=0.0162), however complications were not significant due to confounding with T1. Conclusion: The articulating advanced bipolar device was shown to have a statistically-significant increase in surgeon-perceived workload and rate of device failure when used in TLH; however, the devices had equivalent outcomes and additional costs. 96
Open Communications 6 - New Instrumentation or Technology (12:10 PM - 1:10 PM) 12:17 PM – GROUP A
Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Myomas and Laparoscopic Myomectomy (LM): Clinical Outcomes at Three Years from a Randomized Trial of UterineSparing Techniques amer B,2 Taran A,2 Kraemer D,2 Brucker S,2 Hahn M.2 Isaacson KB,1 Kr€ 1 Harvard Medical School, Boston, Massachusetts; 2Department of Obstetrics and Gynecology, University of T€ubingen, T€ubingen, Germany Study Objective: Compare subject-reported outcomes at 36 months post RFVTA and LM. Design: 1:1 Randomized, prospective, single-center, longitudinal analysis of RFVTA to LM at 36 months of follow-up. Setting: University hospital in Germany. Patients: Fifty premenopausal women R18 years old with symptomatic myomas who desired uterine conservation and reproductive function
and who were indicated for surgical intervention for their myoma symptoms. Intervention: RFVTA or laparoscopic myomectomy. Measurements and Main Results: Consented subjects were randomized (1:1) intraoperatively to RFVTA or LM after laparoscopic (contact) ultrasound mapping of their myomas. Thirty-five subjects (RFVTA: n=18; LM: n=17) have 36-month postoperative evaluations based on validated questionnaires. Mean transformed symptom severity scores improved (decreased) for the RFVTA subjects by –52.9% from the mean baseline value to 16.814.8 [95% CI: 9.5, 24.2]. Over the same period, mean transformed symptom severity scores improved for the LM subjects by –52.1% to 19.718.0 [95% CI: 10.1, 29.3]. At 36 months, health-related quality-of-life (HRQL) scores improved (increased) over baseline for RFVTA subjects by 8.2% to 88.27.6 [95% CI: 84.4, 92.0] and, for LM subjects, by 24.5% to 85.622.6 [95% CI: 73.6, 97.7]. Mean EQ-5D scores improved (increased) from baseline for RFVTA subjects by 18.0% to 84.920.4 [95% CI: 76.8–93.0] and for LM subjects by 17.1% to 78.921.2 [95% CI: 67.6, 90.2]. There were 4 pregnancies with 3 deliveries and 1 pending of healthy infants in the RFVTA group and 7 pregnancies with 6 deliveries of healthy infants in the LM Group. RFVTA (64.3%) and LM (78.6%) subjects were moderately to very satisfied with their treatment. None of the differences was statistically significant. Conclusion: Early three-year data suggest the equivalence in the clinical efficacy of RFVTA to laparoscopic myomectomy. Additional study participants will be followed to their 3-year postoperative visit and a final data analysis will be prepared by August 2016. 97
Open Communications 6 - New Instrumentation or Technology (12:10 PM - 1:10 PM) 12:24 PM – GROUP A
Contained Power Morcellation versus Transvaginal Extraction for Myoma Retrieval: A Prospective Comparison of Perioperative Outcomes Boza A,2 Misirlioglu S,1 Aksu S,2 Arslan T,2 Oktem O,1 Ata B,1 Taskiran C,1 Urman B.1 1Department of Obstetrics and Gynecology, VKF Koc University School of Medicine, Topkapi, Istanbul, Turkey; 2Women’s Health Center, VKF American Hospital, Nisantasi, Istanbul, Turkey Study Objective: To compare the perioperative outcomes of transvaginal extraction (TVE) and contained power morcellation within an insufflated isolation bag (CPM) for myoma retrieval after laparoscopic myomectomy.
Abstracts / Journal of Minimally Invasive Gynecology 23 (2016) S1–S252
Table 1 Enseal (n = 70) Mean +/- Std Dev (%) Baseline Covariates Age BMI (kg/m2) Parity Prior laparoscopies Prior laparotomies Uterine weight (grams) Study Objectives RTLX average T1 (minutes) EBL (mL) Any complications Device failures
Median (IQR)
41.6 +/- 6.9 35.6 +/- 10.1
Ligasure (n = 70) Mean +/- Std Dev (%)
Test for Difference Median (IQR)
41.3 +/- 7.7 34.3 +/- 9.1 2 1 0 165
(1-3) (0-1) (0-1) (11.5-289.8)
51.7 (39.6-59) 35 (25-48) 100 (50-200)
(n=69) 1 (1.4%) 10 (14.3%)
T-test Chi square
0.8356 0.4211 2 1 0 148.7
(1-3) (0-2) (0-1) (84.2-261.5)
0.3445 0.1345 0.2117 0.3445
\0.0001 0.0281 0.5823
32.5 (17.7-48.1) 30 (22-40.8) 100 (50-150)
(n=70)
Mann-Whitney U-test
2 (2.9%) 0 (0%)
1.0000 0.0031
Statistically-significant differences in higher RTLX scores (p=[lt]0.0001) and device failures (p=0.0031) for the articulating device. Noted longer time to ligation of the bilateral uterine arteries (p=0.0281) for the articulating device. Table 2
Intercept Enseal device T1 Device failures Uterine weight BMI
Coefficient
LCI
UCI
p-value
13.13 15.04 0.23 2.18 0.011 0.29
8.83 0.04 -9.87 0.000 -0.02
21.25 0.42 14.23 0.023 0.6
\0.0001 0.0191 0.7215 0.0485 0.0669
RTLX = raw Task Load Index. LCI = lower-end confidence interval. UCI = upper-end confidence interval. T1 = time to ligation of bilateral uterine arteries. BMI = body mass index. No significant differences seen in EBL or additional costs. Multivariate regression analysis of average RTLX score revealed statistically-significant differences in articulating device (p=\0.0001) and T1 (p=0.0162), however complications were not significant due to confounding with T1. Conclusion: The articulating advanced bipolar device was shown to have a statistically-significant increase in surgeon-perceived workload and rate of device failure when used in TLH; however, the devices had equivalent outcomes and additional costs. 96
Open Communications 6 - New Instrumentation or Technology (12:10 PM - 1:10 PM) 12:17 PM – GROUP A
Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Myomas and Laparoscopic Myomectomy (LM): Clinical Outcomes at Three Years from a Randomized Trial of UterineSparing Techniques amer B,2 Taran A,2 Kraemer D,2 Brucker S,2 Hahn M.2 Isaacson KB,1 Kr€ 1 Harvard Medical School, Boston, Massachusetts; 2Department of Obstetrics and Gynecology, University of T€ubingen, T€ubingen, Germany Study Objective: Compare subject-reported outcomes at 36 months post RFVTA and LM. Design: 1:1 Randomized, prospective, single-center, longitudinal analysis of RFVTA to LM at 36 months of follow-up. Setting: University hospital in Germany. Patients: Fifty premenopausal women R18 years old with symptomatic myomas who desired uterine conservation and reproductive function
and who were indicated for surgical intervention for their myoma symptoms. Intervention: RFVTA or laparoscopic myomectomy. Measurements and Main Results: Consented subjects were randomized (1:1) intraoperatively to RFVTA or LM after laparoscopic (contact) ultrasound mapping of their myomas. Thirty-five subjects (RFVTA: n=18; LM: n=17) have 36-month postoperative evaluations based on validated questionnaires. Mean transformed symptom severity scores improved (decreased) for the RFVTA subjects by –52.9% from the mean baseline value to 16.814.8 [95% CI: 9.5, 24.2]. Over the same period, mean transformed symptom severity scores improved for the LM subjects by –52.1% to 19.718.0 [95% CI: 10.1, 29.3]. At 36 months, health-related quality-of-life (HRQL) scores improved (increased) over baseline for RFVTA subjects by 8.2% to 88.27.6 [95% CI: 84.4, 92.0] and, for LM subjects, by 24.5% to 85.622.6 [95% CI: 73.6, 97.7]. Mean EQ-5D scores improved (increased) from baseline for RFVTA subjects by 18.0% to 84.920.4 [95% CI: 76.8–93.0] and for LM subjects by 17.1% to 78.921.2 [95% CI: 67.6, 90.2]. There were 4 pregnancies with 3 deliveries and 1 pending of healthy infants in the RFVTA group and 7 pregnancies with 6 deliveries of healthy infants in the LM Group. RFVTA (64.3%) and LM (78.6%) subjects were moderately to very satisfied with their treatment. None of the differences was statistically significant. Conclusion: Early three-year data suggest the equivalence in the clinical efficacy of RFVTA to laparoscopic myomectomy. Additional study participants will be followed to their 3-year postoperative visit and a final data analysis will be prepared by August 2016. 97
Open Communications 6 - New Instrumentation or Technology (12:10 PM - 1:10 PM) 12:24 PM – GROUP A
Contained Power Morcellation versus Transvaginal Extraction for Myoma Retrieval: A Prospective Comparison of Perioperative Outcomes Boza A,2 Misirlioglu S,1 Aksu S,2 Arslan T,2 Oktem O,1 Ata B,1 Taskiran C,1 Urman B.1 1Department of Obstetrics and Gynecology, VKF Koc University School of Medicine, Topkapi, Istanbul, Turkey; 2Women’s Health Center, VKF American Hospital, Nisantasi, Istanbul, Turkey Study Objective: To compare the perioperative outcomes of transvaginal extraction (TVE) and contained power morcellation within an insufflated isolation bag (CPM) for myoma retrieval after laparoscopic myomectomy.