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Fertility and Obstetric Outcomes Following Isobaric Gasless Laparoscopic Myomectomy
Abstracts / Journal of Minimally Invasive Gynecology 24 (2017) S1–S201
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standardized force values, an educational simulator can be developed to improve proficiency in Veress needle closed abdominal entry technique for laparoscopic surgery. Design: This was a prospective observational study of patients undergoing elective laparoscopic gynecologic surgery. Setting: The study was performed in the surgical suites of a Connecticut community-based hospital. Patients: Patients scheduled for laparoscopic gynecologic surgery were consented during their pre-operative visits to participate in the study. Twentyeight patients were enrolled and 17 of these patients completed the study. Intervention: An adapter was engineered to connect a digital force gauge to the handle end of a standard Veress needle. This allowed data collection using the Veress needle during closed abdominal entry while continuously measuring the force of penetration in units of gram-Force (gF). All data was obtained using evidence-based laparoscopic techniques by a single boardcertified gynecologic surgeon. Measurements and Main Results: For 17 patients, the peak forces ranged from 332 to 1414 gF with a mean of 752 gF. Patients were divided into two cohorts based on BMI. Mean peak force of entry was 740 ± 60.9 gF for patients with BMI < 26.4 kg/m 2 and 763 ± 49.1 gF for patients with BMI > 26.4 kg/m2 (p = .757, two-tailed student t-test).
Conclusion: There was no significant difference in peak forces between the two cohorts, suggesting entry force is independent of patient BMI. Our study demonstrated standard forces could be quantified using the Veress needle closed abdominal entry technique. With this data, a training simulator for resident education can be developed to mimic similar forces required for Veress needle penetration through the abdominal wall. 128 Proportions in MIGS between both years differed significantly (p ≤ .0001; CI 13.6, 23.8). Conclusion: Implementation of a formal MIGS program in a teaching hospital resulted in a significant increment in the proportion of procedures done with minimally invasive techniques, which are now the most common surgical route for gynecological procedures in our center. Aside from training residents in minimally invasive techniques, this program also provides patients with the proven benefits of MIGS. 127
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:11 PM – GROUP B
Force Required for Veress Needle Entry During Laparoscopy Vu MT, Rodriguez F, Panarelli E, Samuelson R. Obstetrics, Gynecology, and Reproductive Biology, Danbury Hospital, Western Connecticut Health Network, Danbury, Connecticut Study Objective: The purpose of this study was to investigate the amount of force required to enter the abdominal cavity using a Veress needle. We hypothesize the force needed to penetrate the abdominal cavity is consistent among patients regardless of their body mass index (BMI). With
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:18 PM – GROUP B
Fertility and Obstetric Outcomes Following Isobaric Gasless Laparoscopic Myomectomy Cammareri G, Bracco B, Di Simone G, Maggi V, Zavatta A, Ferrazzi EM. Department of the Women, Mother and Neonate, Buzzi Children’s Hospital, Milan, Michigan, Italy Study Objective: To investigate pregnancy rate and obstetric outcomes after isobaric gasless laparoscopic myomectomy. Design: Retrospective study. Setting: Department of the Women, Mother and Neonate, Buzzi Children’s Hospital, University of Milan, Medical School of Clinical Sciences, Milan, Italy. Patients: 104 women aged ≤42 years with 1 or more intramural or subserosal myomas with a mean diameter ≥4 cm, symptomatic, looking for pregnancy. Intervention: Isobaric gasless laparoscopic myomectomy using a subcutaneous lifting system and conventional laparotomic surgical instruments. Measurements and Main Results: The number of myomas removed per patient was 2.16 ± 1.2. The mean diameter of the largest fibroid was 6.78 ± 2.1 cm. Type of myomas was in 99% of cases intramural and in 55% subserosal. The most common symptoms were menorrhagia (71%), metrorrhagia (63%), while bulking symptoms occurred in 34% of cases. During
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Abstracts / Journal of Minimally Invasive Gynecology 24 (2017) S1–S201
surgical performance, uterine cavity was opened in 6%. The median blood loss was 200 mL (I.Q. 100–300 mL). Pregnancy rate was 71% (74/104). We observed 3 (1.3%) early miscarriage and one women required voluntary interruption of pregnancy. The median time to conception after surgery was 62.5 months (I.Q. 50–95 months). In 65 cases (88%) we assisted to term birth (≥37 gestational weeks), while in 3 cases birth was before 37 weeks of gestation (4%). 40 women (58 %) underwent caesarean section (87% elective), 25 (37%) had vaginal delivery and 31 (45%) had operative vaginal delivery. In 25% cases the indication for cesarean section was previous myomectomy and, in 7.5 %, there were placental anomalies. The median blood loss at delivery was 400 mL (I.Q. 262–600 mL), in 15% of cases a severe post-partum hemorrhage occurred (defined as blood loss ≥ 1000 mL). No uterine rupture during pregnancy or delivery occurred. Conclusion: women undergoing isobaric myomectomy have good pregnancy rate and positive obstetric outcomes. 129
Secondary outcomes: Fibroid Center patient had a higher Minimally Invasive Surgery (MIGS) rate 78% vs. 33%. (surgical complexity confirmed by uterine weight distribution) with a shorter inpatient length of stay 2.60 vs 4.29 days: 95%CI: (−0.953, 0.684); estimated effect size: −0.116, p-value = .781.
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:29 PM – GROUP C
The Fibroid Center as Model a of Health Care Delivery That Improves Health Care Utilization and Quality Shah AJ,1 Anderman J,1 Florence AM,2 Goldstein JA1. 1Division of Minimally Invasive Gynecology, Department of Obstetrics and Gynecology, Bronx Lebanon Hospital Center, Bronx, New York; 2School of Medicine, American University of the Caribbean, Coral Gables, Florida Study Objective: To assess the effect of our care model on quality measures and resource utilization. Design: Relational model database derived from the active medical record (EMR) was used to create a cohort of patients from whose digital data could be queried. Novel SQL code was created to “read” the electronic medical record. Each variable assessed by multiple queries types: keywords, codes, clinical and registration information. Setting: An urban health care system comprised of 972 bed teaching hospital and outpatient clinics – utilizing the same EMR. Patients: Women, 18–55, diagnosed with fibroids from 2011–2016. Intervention: The Fibroid Center (August 2014) an integrative outpatient/ inpatient model of care. Measurements and Main Results: 3503 18–55 year old women were treated for fibroids from 2013–2016: 407 at the Fibroid Center, 1997 in the gyn outpatient clinic – chi square and student t test confirmed demographically similarity between the 2 groups (age, zip code, insurance type). Health care utilization data included admission, emergency department, and outpatient clinic visits. R, an open source statistics-computing language was employed to evaluate the data. Negative binomial models demonstrates fibroid center patients have an increase use of outpatient clinics 95%CI: (0.977, 1.524); estimated effect size: 1.251, p-value < .001. With a concomitant reduction in emergency room utilization 95%CI: (−0.989, −0.303); estimated effect size: −0.646, p-value < .001.
Fig. 2. Minimally invasive surgery rate and specimen weight 2013–2016.
Conclusion: Patients treated at the Fibroid Center have decreased emergency room utilization with concurrent higher outpatient clinical utilization, and shorter length of stay for hospital admission, which may be due to the higher MIGS rate. 130
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:36 PM – GROUP C
Quality of Life After Myomectomy Rodriguez-Triana VM, Kelly M, Olson T, Parker WH. Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, California Study Objective: To analyze patients’ quality of life and severity of symptoms before and after undergoing either laparoscopic or abdominal myomectomy for symptomatic fibroids. Design: Prospective cohort study. Setting: Academic university hospital. Patients: Patients undergoing either laparoscopic or abdominal myomectomy for symptomatic fibroid uterus between 2014 and 2016. Intervention: Patients undergoing evaluation for myomectomy filled out a validated Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL), and symptoms were scored to achieve a Symptom Severity Score (SSS) and Highest Raw Quality of Life Score (HRQL). Patients who underwent surgery completed the same questionnaire between 6 and 25 months after surgery. Measurements and Main Results: A total of 256 patients completed their preoperative UFS-QOL questionnaire, of which 125 underwent either laparoscopic or abdominal myomectomy. A total of 108 postoperative responses were received (n = 45 between 6–15 months, n = 63 greater than 16 months). For the laparoscopic myomectomy group, the mean pre-operative SSS was 50; the mean HRQL score was 53. Postoperative mean SSS at 6–15 months decreased to 14 and at 16–25 months was also 14; mean HRQL score increased to 94 at 6–15 months and was 92 at 16–25 months. For the abdominal myomectomy group, the mean pre-operative SSS was 55 and HRQL was 43. Post-operative mean SSS at 6–15 months decreased to 14, and at 16–25 months it was 10; mean HRQL score increased to 87 at 6–15 months and was 93 at 16–25 months. Conclusion: Myomectomy can lead to significant improvements in overall quality of life and a decrease in symptom severity in women with symptomatic fibroids. This effect was durable for the duration of our study.
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standardized force values, an educational simulator can be developed to improve proficiency in Veress needle closed abdominal entry technique for laparoscopic surgery. Design: This was a prospective observational study of patients undergoing elective laparoscopic gynecologic surgery. Setting: The study was performed in the surgical suites of a Connecticut community-based hospital. Patients: Patients scheduled for laparoscopic gynecologic surgery were consented during their pre-operative visits to participate in the study. Twentyeight patients were enrolled and 17 of these patients completed the study. Intervention: An adapter was engineered to connect a digital force gauge to the handle end of a standard Veress needle. This allowed data collection using the Veress needle during closed abdominal entry while continuously measuring the force of penetration in units of gram-Force (gF). All data was obtained using evidence-based laparoscopic techniques by a single boardcertified gynecologic surgeon. Measurements and Main Results: For 17 patients, the peak forces ranged from 332 to 1414 gF with a mean of 752 gF. Patients were divided into two cohorts based on BMI. Mean peak force of entry was 740 ± 60.9 gF for patients with BMI < 26.4 kg/m 2 and 763 ± 49.1 gF for patients with BMI > 26.4 kg/m2 (p = .757, two-tailed student t-test).
Conclusion: There was no significant difference in peak forces between the two cohorts, suggesting entry force is independent of patient BMI. Our study demonstrated standard forces could be quantified using the Veress needle closed abdominal entry technique. With this data, a training simulator for resident education can be developed to mimic similar forces required for Veress needle penetration through the abdominal wall. 128 Proportions in MIGS between both years differed significantly (p ≤ .0001; CI 13.6, 23.8). Conclusion: Implementation of a formal MIGS program in a teaching hospital resulted in a significant increment in the proportion of procedures done with minimally invasive techniques, which are now the most common surgical route for gynecological procedures in our center. Aside from training residents in minimally invasive techniques, this program also provides patients with the proven benefits of MIGS. 127
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:11 PM – GROUP B
Force Required for Veress Needle Entry During Laparoscopy Vu MT, Rodriguez F, Panarelli E, Samuelson R. Obstetrics, Gynecology, and Reproductive Biology, Danbury Hospital, Western Connecticut Health Network, Danbury, Connecticut Study Objective: The purpose of this study was to investigate the amount of force required to enter the abdominal cavity using a Veress needle. We hypothesize the force needed to penetrate the abdominal cavity is consistent among patients regardless of their body mass index (BMI). With
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:18 PM – GROUP B
Fertility and Obstetric Outcomes Following Isobaric Gasless Laparoscopic Myomectomy Cammareri G, Bracco B, Di Simone G, Maggi V, Zavatta A, Ferrazzi EM. Department of the Women, Mother and Neonate, Buzzi Children’s Hospital, Milan, Michigan, Italy Study Objective: To investigate pregnancy rate and obstetric outcomes after isobaric gasless laparoscopic myomectomy. Design: Retrospective study. Setting: Department of the Women, Mother and Neonate, Buzzi Children’s Hospital, University of Milan, Medical School of Clinical Sciences, Milan, Italy. Patients: 104 women aged ≤42 years with 1 or more intramural or subserosal myomas with a mean diameter ≥4 cm, symptomatic, looking for pregnancy. Intervention: Isobaric gasless laparoscopic myomectomy using a subcutaneous lifting system and conventional laparotomic surgical instruments. Measurements and Main Results: The number of myomas removed per patient was 2.16 ± 1.2. The mean diameter of the largest fibroid was 6.78 ± 2.1 cm. Type of myomas was in 99% of cases intramural and in 55% subserosal. The most common symptoms were menorrhagia (71%), metrorrhagia (63%), while bulking symptoms occurred in 34% of cases. During
S54
Abstracts / Journal of Minimally Invasive Gynecology 24 (2017) S1–S201
surgical performance, uterine cavity was opened in 6%. The median blood loss was 200 mL (I.Q. 100–300 mL). Pregnancy rate was 71% (74/104). We observed 3 (1.3%) early miscarriage and one women required voluntary interruption of pregnancy. The median time to conception after surgery was 62.5 months (I.Q. 50–95 months). In 65 cases (88%) we assisted to term birth (≥37 gestational weeks), while in 3 cases birth was before 37 weeks of gestation (4%). 40 women (58 %) underwent caesarean section (87% elective), 25 (37%) had vaginal delivery and 31 (45%) had operative vaginal delivery. In 25% cases the indication for cesarean section was previous myomectomy and, in 7.5 %, there were placental anomalies. The median blood loss at delivery was 400 mL (I.Q. 262–600 mL), in 15% of cases a severe post-partum hemorrhage occurred (defined as blood loss ≥ 1000 mL). No uterine rupture during pregnancy or delivery occurred. Conclusion: women undergoing isobaric myomectomy have good pregnancy rate and positive obstetric outcomes. 129
Secondary outcomes: Fibroid Center patient had a higher Minimally Invasive Surgery (MIGS) rate 78% vs. 33%. (surgical complexity confirmed by uterine weight distribution) with a shorter inpatient length of stay 2.60 vs 4.29 days: 95%CI: (−0.953, 0.684); estimated effect size: −0.116, p-value = .781.
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:29 PM – GROUP C
The Fibroid Center as Model a of Health Care Delivery That Improves Health Care Utilization and Quality Shah AJ,1 Anderman J,1 Florence AM,2 Goldstein JA1. 1Division of Minimally Invasive Gynecology, Department of Obstetrics and Gynecology, Bronx Lebanon Hospital Center, Bronx, New York; 2School of Medicine, American University of the Caribbean, Coral Gables, Florida Study Objective: To assess the effect of our care model on quality measures and resource utilization. Design: Relational model database derived from the active medical record (EMR) was used to create a cohort of patients from whose digital data could be queried. Novel SQL code was created to “read” the electronic medical record. Each variable assessed by multiple queries types: keywords, codes, clinical and registration information. Setting: An urban health care system comprised of 972 bed teaching hospital and outpatient clinics – utilizing the same EMR. Patients: Women, 18–55, diagnosed with fibroids from 2011–2016. Intervention: The Fibroid Center (August 2014) an integrative outpatient/ inpatient model of care. Measurements and Main Results: 3503 18–55 year old women were treated for fibroids from 2013–2016: 407 at the Fibroid Center, 1997 in the gyn outpatient clinic – chi square and student t test confirmed demographically similarity between the 2 groups (age, zip code, insurance type). Health care utilization data included admission, emergency department, and outpatient clinic visits. R, an open source statistics-computing language was employed to evaluate the data. Negative binomial models demonstrates fibroid center patients have an increase use of outpatient clinics 95%CI: (0.977, 1.524); estimated effect size: 1.251, p-value < .001. With a concomitant reduction in emergency room utilization 95%CI: (−0.989, −0.303); estimated effect size: −0.646, p-value < .001.
Fig. 2. Minimally invasive surgery rate and specimen weight 2013–2016.
Conclusion: Patients treated at the Fibroid Center have decreased emergency room utilization with concurrent higher outpatient clinical utilization, and shorter length of stay for hospital admission, which may be due to the higher MIGS rate. 130
Open Communications 9 – Laparoscopy (3:25 PM–5:05 PM) 4:36 PM – GROUP C
Quality of Life After Myomectomy Rodriguez-Triana VM, Kelly M, Olson T, Parker WH. Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, California Study Objective: To analyze patients’ quality of life and severity of symptoms before and after undergoing either laparoscopic or abdominal myomectomy for symptomatic fibroids. Design: Prospective cohort study. Setting: Academic university hospital. Patients: Patients undergoing either laparoscopic or abdominal myomectomy for symptomatic fibroid uterus between 2014 and 2016. Intervention: Patients undergoing evaluation for myomectomy filled out a validated Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL), and symptoms were scored to achieve a Symptom Severity Score (SSS) and Highest Raw Quality of Life Score (HRQL). Patients who underwent surgery completed the same questionnaire between 6 and 25 months after surgery. Measurements and Main Results: A total of 256 patients completed their preoperative UFS-QOL questionnaire, of which 125 underwent either laparoscopic or abdominal myomectomy. A total of 108 postoperative responses were received (n = 45 between 6–15 months, n = 63 greater than 16 months). For the laparoscopic myomectomy group, the mean pre-operative SSS was 50; the mean HRQL score was 53. Postoperative mean SSS at 6–15 months decreased to 14 and at 16–25 months was also 14; mean HRQL score increased to 94 at 6–15 months and was 92 at 16–25 months. For the abdominal myomectomy group, the mean pre-operative SSS was 55 and HRQL was 43. Post-operative mean SSS at 6–15 months decreased to 14, and at 16–25 months it was 10; mean HRQL score increased to 87 at 6–15 months and was 93 at 16–25 months. Conclusion: Myomectomy can lead to significant improvements in overall quality of life and a decrease in symptom severity in women with symptomatic fibroids. This effect was durable for the duration of our study.