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The ULTRA Registry: Uterine Leiomyoma Treatment with Radiofrequency Ablation
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S136–S190 3
New York; Obstetrics & Gynecology, Atlantic Health Systems, Summit, New Jersey Study Objective: Although ACOG Bulletin #372 as recommends cystoscopy as post pelvic procedure assessment tool, its adoption has been hindered by the complexity and risks associated with the existing approaches. CystoSureÔ 4-Way Catheter
adds a fourth port with a sealed entry to the standard three-way urinary catheter to allow insertion of a cystoscopic telescope and facilitate standardized diagnostic cystoscopy. The system includes a urinary drainage catheter with a 5 cc distal balloon and standard ports for bladder drainage and irrigation each with an independent means for control. This cadaver study was performed as a proof of concept trial to evaluate the ability to visualize the bladder and ureteral ostia using CystoSureÔ and to assess the difference between 30 and 70 degree cystoscopes. Design: Three different surgeons (NK, LD and RR) performed cystoscopies using the CystoSureÔ 4-Way Catheter (Emmy Medical LLC, Holliston, MA) on five fresh, unembalmed female cadavers. The bladders were catheterized with the CystoSureÔ device and distended with normal saline. 2.9 mm 30 degree and 2.7 mm 70 degree rod lens cystoscopes with working lengths of 200 mm (Emmy Medical LLC, Holliston, MA) were introduced into the bladder through the CystoSureÔ device and the bladder and ureteral ostia were assessed. Setting: Cadaver lab. Patients: Fresh, unembalmed cadavers. Intervention: Cystoscopic bladder evaluations. Measurements and Main Results: In all five cadavers, the bladder and ureteral ostia were able to be fully visualized with CystoSureÔ. In all three trials, all three surgeons agreed the scope with the 70 degree viewing angle provided an easier and more comfortable visualization of the bladder and ureteral ostia. Conclusion: This small pilot cadaver study confirms CystoSureÔ 4-Way Catheter’s ability to adequately visualize the bladder and ureteral ostia is a standard fashion. The use of a 70 degree viewing angle provided an easier and more comfortable visualization of the bladder and ureteral ostia. 582 The ULTRA Registry: Uterine Leiomyoma Treatment with Radiofrequency Ablation Jacoby VL,1 Saberi N,2 Parvataneni R,3 Varon S,4 Waetjen E.5 1Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California; 2University of California, Irvine; 3 University of California, Los Angeles; 4University of California, San Diego; 5University of California, Davis Study Objective: To evaluate the safety and efficacy of laparoscopic radiofrequency ablation of uterine fibroids at the outset as this surgery is being adopted into clinical practice. This is the only study of laparoscopic radiofrequency ablation in the United States since the ablation device (AcessaTM) received FDA approval in November 2012. Design: A nationwide post-market prospective registry of women with fibroids undergoing laparoscopic radiofrequency ablation. Setting: Participants are recruited from all gynecologic practices within the United States that perform laparoscopic radiofrequency ablation for fibroids.
S183
Patients: Women age 21 years and older who plan to undergo laparoscopic radiofrequency ablation for fibroids. Intervention: Women enrolled in the ULTRA Registry will undergo laparoscopic radiofrequency ablation by their local gynecologist. Participants will be asked to complete validated questionnaires about their reproductive health and fibroid-related symptoms prior to surgery and every 6 months after surgery for 3 years. Fibroid imaging studies and operative reports will be reviewed. All reported surgical complications will be adjudicated by an independent reviewer. Gynecologists performing radiofrequency ablation will complete a survey on demographics, surgical training, and practice setting. Measurements and Main Results: The ULTRA Registry will open May 15, 2014. Prior to launching the registry, 75% of practices that perform laparoscopic radiofrequency ablation had agreed to enroll patients. In California, the ULTRA Trial, a pilot study that laid the foundation for the ULTRA Registry, had 10 enrolled participants within the University of California Fibroid Network. The registry data will evaluate the effect of laparoscopic radiofrequency ablation on: 1) surgical morbidity, 2) fibroidrelated symptoms, 3) fertility and pregnancy outcomes, and 4) the need for additional fibroid surgery. Based on current clinical volume, we anticipate 50-75 study participants by November 2014 at AAGL. Conclusion: A nationwide registry to evaluate laparoscopic radiofrequency ablation will collect critical outcome data to guide and inform surgical practice. 583 Efficacy of Protocol for Enhanced Recovery after Surgery: The Use of Preoperative Oral Rehydration for Patients Undergoing Gynecologic Laparoscopic Surgery Jinushi M, Kitade M, Kumakiri J, Kuroda K, Takeda S. Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Bunkyou-ku, Tokyo, Japan Study Objective: To evaluate the benefit and efficacy of a protocol for enhanced recovery after surgery (ERAS) that uses preoperative oral rehydration for patients undergoing gynecologic laparoscopic surgery. Design: Retrospective study. Setting: University hospital. Patients: Patients who underwent laparoscopic surgery at our hospital from January 2013 to May 2013. Intervention: Laparoscopic surgery, questionnaire after surgery. Measurements and Main Results: Patients were given 500ml of a 2.5% oral rehydration solution (OS-1) and 250ml of an 18% carbohydrate beverage (Arginaid water) preoperatively, between one day and two hours before surgery. Two-hundred and nine patients who responded to the questionnaire after surgery were assessed with regard to their degree of satisfaction and their rate of postoperative nausea and vomiting. The results were then compared with those for a control group of 355 patients, who were managed with a previous protocol not involving rehydration. More than 70% of patients treated with the ERAS protocol were satisfied, and found that it allayed their stress and anxiety about the surgery. The rate of nausea and vomiting one day post-operation among patients treated with the ERAS protocol was also significantly lower than that for the control group (24% vs. 48%, P\0.05). Conclusion: The ERAS protocol using preoperative oral rehydration is a useful means of managing gynecologic laparoscopic surgery and has promising results with regard to postoperative patient satisfaction. 584 Transatlantic Intraoperative Telementoring Using Standard Videoconference Technology: A Gynecologic Case Report Lombardi TM,1 Stepp KJ,2 Brown S.1 1Ob-Gyn, Carolinas Medical Center, Charlotte, North Carolina; 2Ob-Gyn, Carolinas Medical Center - Mercy, Charlotte, North Carolina
New York; Obstetrics & Gynecology, Atlantic Health Systems, Summit, New Jersey Study Objective: Although ACOG Bulletin #372 as recommends cystoscopy as post pelvic procedure assessment tool, its adoption has been hindered by the complexity and risks associated with the existing approaches. CystoSureÔ 4-Way Catheter
adds a fourth port with a sealed entry to the standard three-way urinary catheter to allow insertion of a cystoscopic telescope and facilitate standardized diagnostic cystoscopy. The system includes a urinary drainage catheter with a 5 cc distal balloon and standard ports for bladder drainage and irrigation each with an independent means for control. This cadaver study was performed as a proof of concept trial to evaluate the ability to visualize the bladder and ureteral ostia using CystoSureÔ and to assess the difference between 30 and 70 degree cystoscopes. Design: Three different surgeons (NK, LD and RR) performed cystoscopies using the CystoSureÔ 4-Way Catheter (Emmy Medical LLC, Holliston, MA) on five fresh, unembalmed female cadavers. The bladders were catheterized with the CystoSureÔ device and distended with normal saline. 2.9 mm 30 degree and 2.7 mm 70 degree rod lens cystoscopes with working lengths of 200 mm (Emmy Medical LLC, Holliston, MA) were introduced into the bladder through the CystoSureÔ device and the bladder and ureteral ostia were assessed. Setting: Cadaver lab. Patients: Fresh, unembalmed cadavers. Intervention: Cystoscopic bladder evaluations. Measurements and Main Results: In all five cadavers, the bladder and ureteral ostia were able to be fully visualized with CystoSureÔ. In all three trials, all three surgeons agreed the scope with the 70 degree viewing angle provided an easier and more comfortable visualization of the bladder and ureteral ostia. Conclusion: This small pilot cadaver study confirms CystoSureÔ 4-Way Catheter’s ability to adequately visualize the bladder and ureteral ostia is a standard fashion. The use of a 70 degree viewing angle provided an easier and more comfortable visualization of the bladder and ureteral ostia. 582 The ULTRA Registry: Uterine Leiomyoma Treatment with Radiofrequency Ablation Jacoby VL,1 Saberi N,2 Parvataneni R,3 Varon S,4 Waetjen E.5 1Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California; 2University of California, Irvine; 3 University of California, Los Angeles; 4University of California, San Diego; 5University of California, Davis Study Objective: To evaluate the safety and efficacy of laparoscopic radiofrequency ablation of uterine fibroids at the outset as this surgery is being adopted into clinical practice. This is the only study of laparoscopic radiofrequency ablation in the United States since the ablation device (AcessaTM) received FDA approval in November 2012. Design: A nationwide post-market prospective registry of women with fibroids undergoing laparoscopic radiofrequency ablation. Setting: Participants are recruited from all gynecologic practices within the United States that perform laparoscopic radiofrequency ablation for fibroids.
S183
Patients: Women age 21 years and older who plan to undergo laparoscopic radiofrequency ablation for fibroids. Intervention: Women enrolled in the ULTRA Registry will undergo laparoscopic radiofrequency ablation by their local gynecologist. Participants will be asked to complete validated questionnaires about their reproductive health and fibroid-related symptoms prior to surgery and every 6 months after surgery for 3 years. Fibroid imaging studies and operative reports will be reviewed. All reported surgical complications will be adjudicated by an independent reviewer. Gynecologists performing radiofrequency ablation will complete a survey on demographics, surgical training, and practice setting. Measurements and Main Results: The ULTRA Registry will open May 15, 2014. Prior to launching the registry, 75% of practices that perform laparoscopic radiofrequency ablation had agreed to enroll patients. In California, the ULTRA Trial, a pilot study that laid the foundation for the ULTRA Registry, had 10 enrolled participants within the University of California Fibroid Network. The registry data will evaluate the effect of laparoscopic radiofrequency ablation on: 1) surgical morbidity, 2) fibroidrelated symptoms, 3) fertility and pregnancy outcomes, and 4) the need for additional fibroid surgery. Based on current clinical volume, we anticipate 50-75 study participants by November 2014 at AAGL. Conclusion: A nationwide registry to evaluate laparoscopic radiofrequency ablation will collect critical outcome data to guide and inform surgical practice. 583 Efficacy of Protocol for Enhanced Recovery after Surgery: The Use of Preoperative Oral Rehydration for Patients Undergoing Gynecologic Laparoscopic Surgery Jinushi M, Kitade M, Kumakiri J, Kuroda K, Takeda S. Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Bunkyou-ku, Tokyo, Japan Study Objective: To evaluate the benefit and efficacy of a protocol for enhanced recovery after surgery (ERAS) that uses preoperative oral rehydration for patients undergoing gynecologic laparoscopic surgery. Design: Retrospective study. Setting: University hospital. Patients: Patients who underwent laparoscopic surgery at our hospital from January 2013 to May 2013. Intervention: Laparoscopic surgery, questionnaire after surgery. Measurements and Main Results: Patients were given 500ml of a 2.5% oral rehydration solution (OS-1) and 250ml of an 18% carbohydrate beverage (Arginaid water) preoperatively, between one day and two hours before surgery. Two-hundred and nine patients who responded to the questionnaire after surgery were assessed with regard to their degree of satisfaction and their rate of postoperative nausea and vomiting. The results were then compared with those for a control group of 355 patients, who were managed with a previous protocol not involving rehydration. More than 70% of patients treated with the ERAS protocol were satisfied, and found that it allayed their stress and anxiety about the surgery. The rate of nausea and vomiting one day post-operation among patients treated with the ERAS protocol was also significantly lower than that for the control group (24% vs. 48%, P\0.05). Conclusion: The ERAS protocol using preoperative oral rehydration is a useful means of managing gynecologic laparoscopic surgery and has promising results with regard to postoperative patient satisfaction. 584 Transatlantic Intraoperative Telementoring Using Standard Videoconference Technology: A Gynecologic Case Report Lombardi TM,1 Stepp KJ,2 Brown S.1 1Ob-Gyn, Carolinas Medical Center, Charlotte, North Carolina; 2Ob-Gyn, Carolinas Medical Center - Mercy, Charlotte, North Carolina