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129: A Curriculum Module for Teaching Residents Thermachoice Endometrial Ablation Using an Objective Structured Assessment of Technical Skills (OSATS)
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Journal of Minimally Invasive Gynecology, Vol 14, No 6, November/December Supplement 2007
Setting: Urogynecology and reconstructive pelvic surgery practice in community based, university affiliated teaching hospital. Patients: Five underwent a robotic, laparoscopic, supracervical hysterectomy and colpopexy using the da Vinci robot. Intervention: An anterior and posterior arm of soft prolene mesh were utilized in all cases. The mesh pieces were sutured to the sacrum and the cervix using permanent suture. The mesh was reperitonealized. Other needed sitespecific prolapse procedures were also performed concomitantly. Measurements and Main Results: All cases were uncomplicated and successfully completed. Average age was 64, operating time ranged from 4 to 6 hours, and the length of stay ranged from 24 to 36 hours. Minimum follow– up was 12 months. No recurrence of prolapse has been noted to date. Conclusion: The cervix serves as the attachment point for the ligaments and fascia supporting the pelvic floor. Using the cervix as the mesh attachment point may be a better choice in this group of patients. In properly selected women, the future risk of cervical cancer is less than 1/1000. Further investigation into this option is needed. 127 Hysteroscopic Tubal Sterilization: A Cost-effective Procedure on an Outpatient Basis Franchini M, Lippi G. Gynecology Freestanding Unit, Firenze, Italy Study Objective: To compare the institutional cost of permanent female sterilization by Essure hysteroscopic procedure in a day surgery setting or on an outpatient basis. Design: Cost-minimisation analysis. Setting: Department of Gynecology at a Freestanding Unit. Patients: Fifty-six women of reproductive age seeking permanent birth control. Intervention: Hyseroscopic placement of Essure device, in an operating theatre, with either general anaesthesia or intravenous sedation for the first 25 procedures and in an office setting without either intravenous sedation or local anaesthesia for the second 31 cases. The various costs associated with the procedure in a day surgery setting or on an outpatient basis were compiled, and activity-based costing, an advanced cost calculation technique that allocates resource costs to products based on activity consumption, was perfomed. Essure procedure had high costs for disposable equipment. A significantly decrease in costs was detected in perfoming hysteroscopic sterilization on an outpatient basis. The decrease per patient in institutional cost from a day surgery setting to an outpatient basis was 380 euro, because in a day surgery setting the majority of the cost was related to hospital costs (operating room, recovery room, pharmacy). In our insitution, the Essure hysteroscopic sterilization on an outpatient basis had significant cost savings to public health care system.
128 Total Laparoscopic Radical Hysterectomy in an Academic vs Community Setting Frumovitz M, Ramirez P. MD Anderson Cancer Center, Houston, Texas Study Objective: To compare outcomes of total laparoscopic (TLRH) and pelvic lymph node dissection for women with early stage cervical cancer performed at a major academic center (AC) vs a community practice (CP). Design: We retrospectively reviewed all patients who underwent TLRH and pelvic lymphadenectomy. Surgeries were performed either at MD Anderson Cancer Center or in the surrounding community. Patient demographics, preoperative, intraoperative, and postoperative variables were compared using the appropriate statistical tests. Measurements and Main Results: Forty-two women underwent TLRH (23 AC vs. 19 CP). Mean age was 40.5 and mean BMI 28.8. There was no statistically significant difference in age, race, weight, BMI, medical comorbidities, tumor size, stage, grade, or histology between the 2 groups. Median estimated blood loss was 258 ml at the AC vs. 336 in the CP (p ⫽ .56) and 13% of AC patients required blood transfusion compared with 1% for the CP patients (p ⫽ .59). Median operative time was 323 min at the AC vs. 325 min in the CP (p⫽.49). There was no difference in occurrence of intraoperative bowel, vascular, or ureteral injury. On final pathologic examination, there was no significant difference in the amount of parametrial tissue, vaginal cuff, or negative margins obtained. A median of 13 pelvic nodes was obtained in the AC vs 11 for the CP setting (p⫽.19). Hospital length of stay was significantly shorter for the AC setting (1.0 vs 2.0 days, p⫽.003). There were no differences in postoperative infectious or noninfectious morbidities. Likewise, return of voiding function was equivalent in each setting (p ⫽ .3). Conclusion: Although many community gynecologic oncologists may be hesitant to perform TLRH for their patients with cervical cancer, this study shows that it is certainly feasible with outcomes similar to that of a major academic center. 129 A Curriculum Module for Teaching Residents Thermachoice Endometrial Ablation Using an Objective Structured Assessment of Technical Skills (OSATS) Gaba ND, Robinson J. The George Washington University, Washington, DC Study Objective: The purpose of this study was to develop a curriculum module for teaching Thermachoice Endometrial Ablation to Obstetrics and Gynecology residents at The George Washington University. The curriculum was designed to assess the effectiveness of an objective structured assessment of technical skills (OSATS) that was specifically designed for this purpose.
Oral Presentations Design: All residents in the obstetrics and gynecology residency program were eligible to participate in this IRB approved study. Residents attended a 3-hour curriculum session. Each session included a 20-item written pre-test, a hands-on pre-test (OSATS), a didactic lecture, a hands-on practice session with experienced faculty and an industry representative, a 20-item written post-test and a hands-on post-test (OSATS). Experienced faculty served as the scorers for the OSATS. Ethicon Women’s Health and Urology provided plastic uterine models and Thermachoice balloons. Measurements and Main Results: Thirty-six of 40 residents completed the entire curriculum. The mean score on the written pre-test was 51.6% correct. The mean score on the written post-test was 71.2% correct. The OSATS was scored out of 20 possible points. The mean scores for the OSATS were 4.7 and 18.6 on the pre- and post-test respectively. Residents had minimal experience using the device prior to the training module. They rated all aspects of the curriculum very highly. Conclusion: The curriculum model that was developed was effective for teaching residents the principles and techniques of Thermachoice Endometrial Ablation. The project will be continued with a follow-up post-test six-months following the initial intervention to assess retention of the material. These data will be available for presentation at the time of the AAGL meeting. The residents and faculty involved were satisfied with the model used in implementing this curriculum and intend to apply it to the teaching of other surgical procedures and techniques. 130 Using the Essure Micro-insert for the Treatment of Hydrosalpinx Prior to In Vitro Fertilization Galen DI. Reproductive Science Center of the San Francisco Bay Area, San Ramon, California Study Objective: To evaluate the success rate of proximal tubal occlusion with placement of Essure® micro-inserts in women with hydrosalpinx (HS) prior to undergoing in vitro fertilization (IVF), and to observe pregnancy rates post-IVF. Design: Prospective, non-randomized, off-label, observational study of Essure micro-insert placement in women with HS and subsequent pregnancy rates following IVF using fresh or frozen embryos. Setting: Tertiary infertility and IVF private-practice referral center. Patients: Seven women, ages 32-44 presenting with infertility, normal FSH levels (⬍10), normal antral follicle count (10 or more total both ovaries), unilateral or bilateral HS as determined by laparoscopy or hysterosalpingogram (HSG), planning to undergo IVF following tubal occlusion. Intervention: Placement of Essure micro-inserts, followed by an HSG 3 months post-procedure, and IVF. Measurements and Main Results: Bilateral Essure placement was performed in 5 women, unilateral in 1 woman (with a unilateral HS), and 1 unsuccessful placement at-
S49 tempt. The devices were intentionally placed with an average of 2-3 trailing coils visible post-procedure. Follow-up HSG has been completed in 4 patients, with all demonstrating tubal occlusion. One woman elected to not have an HSG, and 1 patient is awaiting her HSG. IVF treatment was initiated in all patients an average of 3.5 months postconfirmation of tubal occlusion. Three women became pregnant on their first IVF cycle with term deliveries, one is currently 3 months pregnant from a frozen embryo cycle, one did not achieve pregnancy and one is awaiting her follow-up HSG prior to beginning IVF. There have been no complications from Essure placement or from the devices remaining in place during pregnancy. Conclusion: Preliminary results demonstrate an excellent pregnancy rate with IVF following Essure placement for HS. The incisional surgical complication rates, as well as costs, are predicted to be reduced using this non-incisional method of tubal occlusion utilizing local anesthesia. 131 Concomitant Essure Tubal Sterilization and Microwave Endometrial Ablation (MEA): A Peri-Hysterectomy Safety Study 1 Garza-Leal JG, 2Coad JE. 1Hospital Universitario, Monterrey, Mexico; 2West Virginia University, Morgantown, West Virginia Study Objective: To evaluate the safety of microwave endometrial ablation in women following transcervical sterilization with an intratubal insert. Design: Open-label safety study involving Essure (Conceptus) placement followed by MEA (Microsulis) in women previously scheduled for abdominal hysterectomy that meet study eligibility criteria and signed informed consent. Setting: University Hospital in Monterey, Mexico. Patients: Ten women, all requiring hysterectomy for benign uterine bleeding. Intervention: The patients in the treatment group sequentially underwent unilateral Essure placement, with the contralateral fallopian tube serving as the patient’s own control. Following laparotomy thermocouples for temperature measurements were placed in the serosa of the fundus, uterine tubal junction and isthmic portion of the fallopian tube. Subsequently MEA was performed followed by, abdominal hysterectomy. Bilateral Essure placement without MEA was performed in one patient as a histology control. Following hysterectomy, the extirpated uteri were pathologically examined for Essure device placement and for ablated tissue around the uterine cornua. Measurements and Main Results: All MEA treatments were successfully completed on nine subjects in the treatment group and Essure placement was successful in all subjects. No visual damage or movement of the Essure device was identified. Mean serosal temperatures ranged from 35°C to 36°C during MEA. All Essure devices were carefully dissected from the cornu and proximal fallopian
Journal of Minimally Invasive Gynecology, Vol 14, No 6, November/December Supplement 2007
Setting: Urogynecology and reconstructive pelvic surgery practice in community based, university affiliated teaching hospital. Patients: Five underwent a robotic, laparoscopic, supracervical hysterectomy and colpopexy using the da Vinci robot. Intervention: An anterior and posterior arm of soft prolene mesh were utilized in all cases. The mesh pieces were sutured to the sacrum and the cervix using permanent suture. The mesh was reperitonealized. Other needed sitespecific prolapse procedures were also performed concomitantly. Measurements and Main Results: All cases were uncomplicated and successfully completed. Average age was 64, operating time ranged from 4 to 6 hours, and the length of stay ranged from 24 to 36 hours. Minimum follow– up was 12 months. No recurrence of prolapse has been noted to date. Conclusion: The cervix serves as the attachment point for the ligaments and fascia supporting the pelvic floor. Using the cervix as the mesh attachment point may be a better choice in this group of patients. In properly selected women, the future risk of cervical cancer is less than 1/1000. Further investigation into this option is needed. 127 Hysteroscopic Tubal Sterilization: A Cost-effective Procedure on an Outpatient Basis Franchini M, Lippi G. Gynecology Freestanding Unit, Firenze, Italy Study Objective: To compare the institutional cost of permanent female sterilization by Essure hysteroscopic procedure in a day surgery setting or on an outpatient basis. Design: Cost-minimisation analysis. Setting: Department of Gynecology at a Freestanding Unit. Patients: Fifty-six women of reproductive age seeking permanent birth control. Intervention: Hyseroscopic placement of Essure device, in an operating theatre, with either general anaesthesia or intravenous sedation for the first 25 procedures and in an office setting without either intravenous sedation or local anaesthesia for the second 31 cases. The various costs associated with the procedure in a day surgery setting or on an outpatient basis were compiled, and activity-based costing, an advanced cost calculation technique that allocates resource costs to products based on activity consumption, was perfomed. Essure procedure had high costs for disposable equipment. A significantly decrease in costs was detected in perfoming hysteroscopic sterilization on an outpatient basis. The decrease per patient in institutional cost from a day surgery setting to an outpatient basis was 380 euro, because in a day surgery setting the majority of the cost was related to hospital costs (operating room, recovery room, pharmacy). In our insitution, the Essure hysteroscopic sterilization on an outpatient basis had significant cost savings to public health care system.
128 Total Laparoscopic Radical Hysterectomy in an Academic vs Community Setting Frumovitz M, Ramirez P. MD Anderson Cancer Center, Houston, Texas Study Objective: To compare outcomes of total laparoscopic (TLRH) and pelvic lymph node dissection for women with early stage cervical cancer performed at a major academic center (AC) vs a community practice (CP). Design: We retrospectively reviewed all patients who underwent TLRH and pelvic lymphadenectomy. Surgeries were performed either at MD Anderson Cancer Center or in the surrounding community. Patient demographics, preoperative, intraoperative, and postoperative variables were compared using the appropriate statistical tests. Measurements and Main Results: Forty-two women underwent TLRH (23 AC vs. 19 CP). Mean age was 40.5 and mean BMI 28.8. There was no statistically significant difference in age, race, weight, BMI, medical comorbidities, tumor size, stage, grade, or histology between the 2 groups. Median estimated blood loss was 258 ml at the AC vs. 336 in the CP (p ⫽ .56) and 13% of AC patients required blood transfusion compared with 1% for the CP patients (p ⫽ .59). Median operative time was 323 min at the AC vs. 325 min in the CP (p⫽.49). There was no difference in occurrence of intraoperative bowel, vascular, or ureteral injury. On final pathologic examination, there was no significant difference in the amount of parametrial tissue, vaginal cuff, or negative margins obtained. A median of 13 pelvic nodes was obtained in the AC vs 11 for the CP setting (p⫽.19). Hospital length of stay was significantly shorter for the AC setting (1.0 vs 2.0 days, p⫽.003). There were no differences in postoperative infectious or noninfectious morbidities. Likewise, return of voiding function was equivalent in each setting (p ⫽ .3). Conclusion: Although many community gynecologic oncologists may be hesitant to perform TLRH for their patients with cervical cancer, this study shows that it is certainly feasible with outcomes similar to that of a major academic center. 129 A Curriculum Module for Teaching Residents Thermachoice Endometrial Ablation Using an Objective Structured Assessment of Technical Skills (OSATS) Gaba ND, Robinson J. The George Washington University, Washington, DC Study Objective: The purpose of this study was to develop a curriculum module for teaching Thermachoice Endometrial Ablation to Obstetrics and Gynecology residents at The George Washington University. The curriculum was designed to assess the effectiveness of an objective structured assessment of technical skills (OSATS) that was specifically designed for this purpose.
Oral Presentations Design: All residents in the obstetrics and gynecology residency program were eligible to participate in this IRB approved study. Residents attended a 3-hour curriculum session. Each session included a 20-item written pre-test, a hands-on pre-test (OSATS), a didactic lecture, a hands-on practice session with experienced faculty and an industry representative, a 20-item written post-test and a hands-on post-test (OSATS). Experienced faculty served as the scorers for the OSATS. Ethicon Women’s Health and Urology provided plastic uterine models and Thermachoice balloons. Measurements and Main Results: Thirty-six of 40 residents completed the entire curriculum. The mean score on the written pre-test was 51.6% correct. The mean score on the written post-test was 71.2% correct. The OSATS was scored out of 20 possible points. The mean scores for the OSATS were 4.7 and 18.6 on the pre- and post-test respectively. Residents had minimal experience using the device prior to the training module. They rated all aspects of the curriculum very highly. Conclusion: The curriculum model that was developed was effective for teaching residents the principles and techniques of Thermachoice Endometrial Ablation. The project will be continued with a follow-up post-test six-months following the initial intervention to assess retention of the material. These data will be available for presentation at the time of the AAGL meeting. The residents and faculty involved were satisfied with the model used in implementing this curriculum and intend to apply it to the teaching of other surgical procedures and techniques. 130 Using the Essure Micro-insert for the Treatment of Hydrosalpinx Prior to In Vitro Fertilization Galen DI. Reproductive Science Center of the San Francisco Bay Area, San Ramon, California Study Objective: To evaluate the success rate of proximal tubal occlusion with placement of Essure® micro-inserts in women with hydrosalpinx (HS) prior to undergoing in vitro fertilization (IVF), and to observe pregnancy rates post-IVF. Design: Prospective, non-randomized, off-label, observational study of Essure micro-insert placement in women with HS and subsequent pregnancy rates following IVF using fresh or frozen embryos. Setting: Tertiary infertility and IVF private-practice referral center. Patients: Seven women, ages 32-44 presenting with infertility, normal FSH levels (⬍10), normal antral follicle count (10 or more total both ovaries), unilateral or bilateral HS as determined by laparoscopy or hysterosalpingogram (HSG), planning to undergo IVF following tubal occlusion. Intervention: Placement of Essure micro-inserts, followed by an HSG 3 months post-procedure, and IVF. Measurements and Main Results: Bilateral Essure placement was performed in 5 women, unilateral in 1 woman (with a unilateral HS), and 1 unsuccessful placement at-
S49 tempt. The devices were intentionally placed with an average of 2-3 trailing coils visible post-procedure. Follow-up HSG has been completed in 4 patients, with all demonstrating tubal occlusion. One woman elected to not have an HSG, and 1 patient is awaiting her HSG. IVF treatment was initiated in all patients an average of 3.5 months postconfirmation of tubal occlusion. Three women became pregnant on their first IVF cycle with term deliveries, one is currently 3 months pregnant from a frozen embryo cycle, one did not achieve pregnancy and one is awaiting her follow-up HSG prior to beginning IVF. There have been no complications from Essure placement or from the devices remaining in place during pregnancy. Conclusion: Preliminary results demonstrate an excellent pregnancy rate with IVF following Essure placement for HS. The incisional surgical complication rates, as well as costs, are predicted to be reduced using this non-incisional method of tubal occlusion utilizing local anesthesia. 131 Concomitant Essure Tubal Sterilization and Microwave Endometrial Ablation (MEA): A Peri-Hysterectomy Safety Study 1 Garza-Leal JG, 2Coad JE. 1Hospital Universitario, Monterrey, Mexico; 2West Virginia University, Morgantown, West Virginia Study Objective: To evaluate the safety of microwave endometrial ablation in women following transcervical sterilization with an intratubal insert. Design: Open-label safety study involving Essure (Conceptus) placement followed by MEA (Microsulis) in women previously scheduled for abdominal hysterectomy that meet study eligibility criteria and signed informed consent. Setting: University Hospital in Monterey, Mexico. Patients: Ten women, all requiring hysterectomy for benign uterine bleeding. Intervention: The patients in the treatment group sequentially underwent unilateral Essure placement, with the contralateral fallopian tube serving as the patient’s own control. Following laparotomy thermocouples for temperature measurements were placed in the serosa of the fundus, uterine tubal junction and isthmic portion of the fallopian tube. Subsequently MEA was performed followed by, abdominal hysterectomy. Bilateral Essure placement without MEA was performed in one patient as a histology control. Following hysterectomy, the extirpated uteri were pathologically examined for Essure device placement and for ablated tissue around the uterine cornua. Measurements and Main Results: All MEA treatments were successfully completed on nine subjects in the treatment group and Essure placement was successful in all subjects. No visual damage or movement of the Essure device was identified. Mean serosal temperatures ranged from 35°C to 36°C during MEA. All Essure devices were carefully dissected from the cornu and proximal fallopian