- Email: [email protected]
The Efficacy and Safety of a New Cross-Linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions after Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90 Setting: University of Michigan and St. Joseph Mercy Hospital in Ann Arbor, Michigan. Patients: Patients who underwent a hysterectomy or myomectomy with morcellation and were subsequently found to have a STUMP or ESS. Measurements and Main Results: Eight patients were identified who underwent morcellation and were subsequently found to have a STUMP or ESS. Four patients underwent power morcellation, two patients underwent hand morcellation, one patient underwent vaginal morcellation and one patient underwent laparoscopic morcellation described as ‘‘bivalving and enucleation.’’ Six patients had a secondary surgical assessment within 42-97 days of the initial procedure. Four patients were found to have benign implants comprised of myometrium or endometrium, one patient had widespread malignant implants, and one patient had no evidence of peritoneal implants. Conclusion: Surgical re-exploration procedures following any type of morcellation of a STUMP or ESS tumor have a significant likelihood of detecting peritoneal implants. The rarity and indolent nature of these tumors makes assessment of survival and progression free interval difficult. Morcellation of any kind, without protection from intraperitoneal spill, can disperse uterine tissue with potential for peritoneal implantation. 196
Open Communications 9 - New Instruments (11:24 AM - 11:29 AM)
Comparative Thermal Effects of J-Plasma, Monopolar, Argon and Laser Electrosurgery in a Porcine Tissue Model Pedroso J, Gutierrez M, Volker KW. Las Vegas Minimally Invasive Surgery-Women’s Pelvic Health Center, Las Vegas, Nevada Study Objective: To understand how J-Plasma surgical energy compares to a monopolar, argon beam and CO2 laser device in terms of depth of thermal spread in a porcine tissue model. Design: Prospective study utilizing porcine tissue models comparing the thermal effects of J-Plasma, Bovie monopolar pencil, Argon Beam Coagulator (ABC), and CO2 Laser at clinically equivalent settings. Setting: Laboratory. Patients: Porcine tissue samples. Intervention: Porcine small intestine, bladder and peritoneal tissues were exposed to J-Plasma at 15% power, 4 L/min gas flow, Bovie monopolar pencil at 30W on cut, Argon Beam Coagulator (ABC) at 70W, 4 L/min, and CO2 Laser super pulse at 12W, held 5mm away from tissue for 5 seconds. These tissues were then evaluated histologically to compare the depth and lateral thermal spread in each tissue at the above clinically equivalent settings. Measurements and Main Results: Compared to the Bovie, ABC, and CO2 Laser, J-Plasma has comparable or lower depth of thermal spread in peritoneal, bladder and small intestinal tissues, with a maximum depth of 0.334mm in small intestine. The ABC had highest depth of thermal spread at 1.8mm in small intestine. Lateral thermal spread of each device varied by tissue type. CO2 Laser had the greatest lateral thermal spread on peritoneum at 2.99mm. ABC had the greatest lateral thermal spread in bladder, 3.51mm, and 3.57mm on small intestine. J-Plasma had comparable if not lower lateral thermal spread in peritoneum, bladder and small intestinal tissues, compared to other devices, with a maximum of 2.63mm on peritoneum. Conclusion: J-Plasma is a newly FDA-approved device that has comparable if not lower depth and lateral thermal effect compared to monopolar, argon and laser electrosurgical devices when applied to various tissue types. Additional studies are needed to demonstrate application of the device in various surgical procedures. 197
Open Communications 9 - New Instruments (11:30 AM - 11:35 AM)
The McCarus-Volker ForniSeeÒ System: A Novel Transilluminating Colpotomy Device and Uterine Manipulator for Use in Conventional and RoboticAssisted Laparoscopic Hysterectomy Gutierrez MM,1 Pedroso JD,1 Dhingra C,1 Volker KW,1 McCarus SD.2 1 Gynecology, Las Vegas Institute of Minimally Invasive Surgery and
S59 2
Women’s Pelvic Health Center, Las Vegas, Nevada; Gynecology, Florida Hospital, Celebration, Florida Study Objective: To introduce a novel transilluminating colpotomy and uterine manipulator device, demonstrate its safety and adequate clinical performance in conventional and robotic-assisted laparoscopic hysterectomy, and illustrate its potential widespread future use in minimally invasive gynecologic procedures. Design: Preclinical cadaver trials were conducted for performance and product testing, followed by clinical trials. The study was a prospective, non-randomized, non-blinded observational clinical study. A literature review was performed to compare the ForniSee to predicate devices. Physician surveys were conducted to evaluate its design, functionality, innovation and value. Setting: Surgeries were performed during March through May 2012 at Florida Hospital and Las Vegas Minimally Invasive Surgery and Pelvic Health Center. Patients: 50 female patients, with specific inclusion criteria, undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (LSH) for benign indications. Intervention: TLH or LSH was performed using the ForniSee uterine manipulator. Measurements and Main Results: Average patient age was 45.06 years. 33 patients had undergone previous intra-abdominal surgery. 38 underwent TLH with one conversion to TAH, due to a 1,695-gram uterus. 12 patients underwent successful LSH. There were no reports of adverse events, difficulty with placement of the instrument, or difficulty with uterine manipulation. There was one device-related uterine perforation. Pneumoperitoneum was maintained in all cases during colpotomy. Vaginal tissue left on specimens was less than 5mm. There were no ureteral injuries. There were two incidental cystotomies. Average blood loss was 99.04 ml. Average uterine weight was 269.87 grams, with a range of 45 grams to 1,695 grams. The largest uterus successfully removed laparoscopically weighed 1,096 grams. There were two postoperative complications; possible vaginal cuff abscess, and a 2cm vaginal mucosal cuff separation. Conclusion: The ForniSee is a novel transilluminating colpotomy device and uterine manipulator that is safe, efficient, functional, cost effective, and easy to use. Transillumination enhances identification of critical anatomic planes. It can potentially improve patient outcomes and reduce procedure times.
198
Open Communications 9 - New Instruments (11:36 AM - 11:41 AM)
The Efficacy and Safety of a New Cross-Linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions after Laparoscopic Gynecological Surgery: A Randomized Controlled Trial Liu C, Zhang Z, Lu Q, Zhang Z. Obstetrics and Gynecology, Beijing ChaoYang Hospital, Capital Medical University, Beijing, China Study Objective: To investigate that it is safe and efficacious to use a new cross-linked hyaluronan hydrogel in the reduction of postsurgical adhesions after laparoscopic gynecological surgery.
S60
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90
Design: This prospective, multicenter, third-party blinded randomized controlled trial was conducted between June 2011 and February 2013. Setting: Department of Obstetrics and Gynecology, Beijing Chao-Yang Hospital, Capital Medical University. Patients: 215 patients undergoing laparoscopic surgery for removal of myomas, ovary cysts, endometriotic cysts and/or adhesions were treated with the new cross-linked hyaluronan hydrogel (n=107) and saline placebo (108). Intervention: A web-based program was used for randomization and a total of 216 subjects with laparoscopic gynecological surgery were included and allocated into the new cross-linked hydrogel arm and control arm with 1:1 ratio. Measurements and Main Results: The pre-existing adhesions at baseline and the postsurgical adhesions by second-look laparoscopy at 9 weeks later were video recorded, and blindly evaluated according to modified American Fertility Society (mAFS) scoring system at the 10 anatomic sites of ovaries and tubes and at the expanded 23/24 anatomic sites throughout abdominopelvic cavity. The efficacies in adhesion reduction and adverse events were compared between two treatments. The incidences of postsurgical adhesions under moderate/severe category (10 anatomical sites of ovaries and tubes), defined as the primary endpoint in efficacy, were 37.0% in control arm and 14.0% in the new cross-linked hyaluronan hydrogel arm with a difference of -20.0% and a 95% CI of [-26.8%; -8.9%] (Full Analysis Set), and were 27.7% in control arm and 9.8% in the new cross-linked hyaluronan hydrogel arm with a difference of -14.4% and a 95% CI of [-20.6%; -2.6%] (Per Protocol Set). There were no serious adverse events reported and the safety profile of HyaRegen gel was comparable to that of saline placebo. Conclusion: The present study shows this new cross-linked hyaluronan hydrogel is safe and efficacious in the reduction of postsurgical adhesions throughout abdominopelvic cavity. 199
Open Communications 9 - New Instruments (11:42 AM - 11:47 AM)
Fibroid Symptom Reduction, Health-Related Quality of Life Improvement and Patient Satisfaction after Radiofrequency Ablation of Uterine Fibroids with the VizAblateÒ System Garza-Leal JG,1 Gupta J,2 Bongers M,3 Br€olmann H,4 Quartero R,5 Veersema S,6 Toub DB.7 1Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Le on, Mexico; 2Birmingham Women’s Hospital, Birmingham, United Kingdom; 3Maxima Medisch Centrum, Veldhoven, Netherlands; 4Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands; 5Medisch Spectrum Twente, Enschede, Netherlands; 6Sint Antonius Ziekenhuis, Nieuwegein, Netherlands; 7Gynesonics, Inc., Redwood City, California Study Objective: To determine improvement in fibroid symptoms and health-related quality of life (HRQOL) along with patient satisfaction after treatment of symptomatic fibroids using the VizAblate System. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: Several academic and community hospitals in the United Kingdom, The Netherlands and Mexico. Patients: Up to 100 women with heavy menstrual bleeding secondary to fibroids. A sample of 40 subjects was sufficient to detect a difference of 22% in the probability of success with a power of 82% using a one-group chi-square test with a 0.05 two-sided significance level. Intervention: Transcervical, intrauterine ultrasound-guided radiofrequency ablation performed on up to 5 fibroids per subject ranging from 1-5 cm in diameter. Measurements and Main Results: Data are for the first 50 treated subjects as of April, 2014. Subjects completed the Uterine Fibroid Symptom and Quality of Life questionnaire and satisfaction was reported using a 5point Likert scale. At baseline (n = 50), the median Symptom Severity Score (SSS) was 61.0 (range; 28.0-100.0) and the median HRQOL was 32.0 (range; 1.0-73.0). At 6 months, the median SSS (n = 49) fell to 19 (range; 0.0-78.0), a 66.1% improvement; median HRQOL (n = 48) increased to 85 (range; 1.0-100.0), a 118.9% improvement. At 12 months (n = 43), median SSS decreased further to 16.0 (range; 0.0-75.0), a 75.8%
improvement; median HRQOL rose higher to 93.0 (range; 28.0-100.0), a 158.8% improvement. At 6 months, 43 of 47 (91.5%) subjects were satisfied with the procedure; 36 of 39 subjects (92.3%) expressed satisfaction at 12 months. Conclusion: Radiofrequency ablation using the VizAblate System provides significant improvements in symptom relief and health-related quality of life, with patients reporting very high levels of satisfaction with their outcomes. 200
Open Communications 9 - New Instruments (11:48 AM - 11:53 AM)
OvalasticÒ: 1st Experience with a New Hysteroscopic Sterilization System Thurkow AL. Ob/Gyn Minimal Invasive Surgery, St. Lucas Andreas Hospital, Amsterdam, NH, Netherlands Study Objective: The first clinical experience with a new device for hysteroscopic sterilization will be presented. Hysteroscopic sterilization has become the standard of care in many countries, due to the ease of use, speed and reliability of the only remaining current device (EssureÒ). In Europe recently a new alternative system received a CE mark: OvalasticÒ. It is an improved evolution from a hysteroscopic sterilization system that actually has a very long history: OvablocÒ, studied in the US in the 70’s and received CE marking in 1990. Both systems consist of a formed-in-place liquid siloxane material inserted by a catheter through the working channel of a hysteroscope. Design: In an observational clinical pilot study the first clinical data with this new version from centers in the Netherlands and in Poland will be presented with a follow-up period ranging from 2 to 36 months. Setting: Ambulatory or conscious sedation in daycare setting. Patients: 15 patients were treated, selection was based on patient preference or contra-indications for Essure sterilization. Intervention: Hysteroscopic Sterilization with Ovalastic formed-in-place silicone material. Measurements and Main Results: The study showed the feasibility of ambulatory sterilization with this device. The overall bilateral placement rate was 79%, failures were related to the learning curve and initial technical imperfections. There was one non-relying pregnancy in a patient who did not comply with the advice to use additional contraception until the confirmation test after 3 months. Conclusion: The study showed the feasibility of ambulatory sterilization with this device. Possible advantages of Ovalastic over other systems include: - inert material, therefore no tissue ingrowth (or adhesions in case of inadvertent perforation) - a soft silicone plug - no nickel - lower cost of material More clinical data are needed, which will be provided in a prospective multicenter clinical study, that is expected to start end of 2014. 201
Open Communications 9 - New Instruments (11:54 AM - 11:59 AM)
Real Time Haptic Feedback in Endoscopy; Dreams Become Reality? The State of Art Vleugels MPH,1 Nieboer B.2 Obstetrics and Gynecology, Riverland Hospital, Tiel, Gelderland, Netherlands; 2Obstetrics and Gynecology, University Medical Center Radboud, Nijmegen, Gelderland, Netherlands Study Objective: Laparoscopic Instruments, conventional and robotic, lack real time haptic feedback due to the high friction of the instruments and low accuracy; no tissue information and no control of the gripping forces is delivered. Our current objective is development of laparoscopic instruments with haptic feedback which are affordable and applicable in all endoscopic operations. Ultimately, this will enhance patient safety and ergonomics for surgeons.
Open Communications 9 - New Instruments (11:24 AM - 11:29 AM)
Comparative Thermal Effects of J-Plasma, Monopolar, Argon and Laser Electrosurgery in a Porcine Tissue Model Pedroso J, Gutierrez M, Volker KW. Las Vegas Minimally Invasive Surgery-Women’s Pelvic Health Center, Las Vegas, Nevada Study Objective: To understand how J-Plasma surgical energy compares to a monopolar, argon beam and CO2 laser device in terms of depth of thermal spread in a porcine tissue model. Design: Prospective study utilizing porcine tissue models comparing the thermal effects of J-Plasma, Bovie monopolar pencil, Argon Beam Coagulator (ABC), and CO2 Laser at clinically equivalent settings. Setting: Laboratory. Patients: Porcine tissue samples. Intervention: Porcine small intestine, bladder and peritoneal tissues were exposed to J-Plasma at 15% power, 4 L/min gas flow, Bovie monopolar pencil at 30W on cut, Argon Beam Coagulator (ABC) at 70W, 4 L/min, and CO2 Laser super pulse at 12W, held 5mm away from tissue for 5 seconds. These tissues were then evaluated histologically to compare the depth and lateral thermal spread in each tissue at the above clinically equivalent settings. Measurements and Main Results: Compared to the Bovie, ABC, and CO2 Laser, J-Plasma has comparable or lower depth of thermal spread in peritoneal, bladder and small intestinal tissues, with a maximum depth of 0.334mm in small intestine. The ABC had highest depth of thermal spread at 1.8mm in small intestine. Lateral thermal spread of each device varied by tissue type. CO2 Laser had the greatest lateral thermal spread on peritoneum at 2.99mm. ABC had the greatest lateral thermal spread in bladder, 3.51mm, and 3.57mm on small intestine. J-Plasma had comparable if not lower lateral thermal spread in peritoneum, bladder and small intestinal tissues, compared to other devices, with a maximum of 2.63mm on peritoneum. Conclusion: J-Plasma is a newly FDA-approved device that has comparable if not lower depth and lateral thermal effect compared to monopolar, argon and laser electrosurgical devices when applied to various tissue types. Additional studies are needed to demonstrate application of the device in various surgical procedures. 197
Open Communications 9 - New Instruments (11:30 AM - 11:35 AM)
The McCarus-Volker ForniSeeÒ System: A Novel Transilluminating Colpotomy Device and Uterine Manipulator for Use in Conventional and RoboticAssisted Laparoscopic Hysterectomy Gutierrez MM,1 Pedroso JD,1 Dhingra C,1 Volker KW,1 McCarus SD.2 1 Gynecology, Las Vegas Institute of Minimally Invasive Surgery and
S59 2
Women’s Pelvic Health Center, Las Vegas, Nevada; Gynecology, Florida Hospital, Celebration, Florida Study Objective: To introduce a novel transilluminating colpotomy and uterine manipulator device, demonstrate its safety and adequate clinical performance in conventional and robotic-assisted laparoscopic hysterectomy, and illustrate its potential widespread future use in minimally invasive gynecologic procedures. Design: Preclinical cadaver trials were conducted for performance and product testing, followed by clinical trials. The study was a prospective, non-randomized, non-blinded observational clinical study. A literature review was performed to compare the ForniSee to predicate devices. Physician surveys were conducted to evaluate its design, functionality, innovation and value. Setting: Surgeries were performed during March through May 2012 at Florida Hospital and Las Vegas Minimally Invasive Surgery and Pelvic Health Center. Patients: 50 female patients, with specific inclusion criteria, undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (LSH) for benign indications. Intervention: TLH or LSH was performed using the ForniSee uterine manipulator. Measurements and Main Results: Average patient age was 45.06 years. 33 patients had undergone previous intra-abdominal surgery. 38 underwent TLH with one conversion to TAH, due to a 1,695-gram uterus. 12 patients underwent successful LSH. There were no reports of adverse events, difficulty with placement of the instrument, or difficulty with uterine manipulation. There was one device-related uterine perforation. Pneumoperitoneum was maintained in all cases during colpotomy. Vaginal tissue left on specimens was less than 5mm. There were no ureteral injuries. There were two incidental cystotomies. Average blood loss was 99.04 ml. Average uterine weight was 269.87 grams, with a range of 45 grams to 1,695 grams. The largest uterus successfully removed laparoscopically weighed 1,096 grams. There were two postoperative complications; possible vaginal cuff abscess, and a 2cm vaginal mucosal cuff separation. Conclusion: The ForniSee is a novel transilluminating colpotomy device and uterine manipulator that is safe, efficient, functional, cost effective, and easy to use. Transillumination enhances identification of critical anatomic planes. It can potentially improve patient outcomes and reduce procedure times.
198
Open Communications 9 - New Instruments (11:36 AM - 11:41 AM)
The Efficacy and Safety of a New Cross-Linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions after Laparoscopic Gynecological Surgery: A Randomized Controlled Trial Liu C, Zhang Z, Lu Q, Zhang Z. Obstetrics and Gynecology, Beijing ChaoYang Hospital, Capital Medical University, Beijing, China Study Objective: To investigate that it is safe and efficacious to use a new cross-linked hyaluronan hydrogel in the reduction of postsurgical adhesions after laparoscopic gynecological surgery.
S60
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90
Design: This prospective, multicenter, third-party blinded randomized controlled trial was conducted between June 2011 and February 2013. Setting: Department of Obstetrics and Gynecology, Beijing Chao-Yang Hospital, Capital Medical University. Patients: 215 patients undergoing laparoscopic surgery for removal of myomas, ovary cysts, endometriotic cysts and/or adhesions were treated with the new cross-linked hyaluronan hydrogel (n=107) and saline placebo (108). Intervention: A web-based program was used for randomization and a total of 216 subjects with laparoscopic gynecological surgery were included and allocated into the new cross-linked hydrogel arm and control arm with 1:1 ratio. Measurements and Main Results: The pre-existing adhesions at baseline and the postsurgical adhesions by second-look laparoscopy at 9 weeks later were video recorded, and blindly evaluated according to modified American Fertility Society (mAFS) scoring system at the 10 anatomic sites of ovaries and tubes and at the expanded 23/24 anatomic sites throughout abdominopelvic cavity. The efficacies in adhesion reduction and adverse events were compared between two treatments. The incidences of postsurgical adhesions under moderate/severe category (10 anatomical sites of ovaries and tubes), defined as the primary endpoint in efficacy, were 37.0% in control arm and 14.0% in the new cross-linked hyaluronan hydrogel arm with a difference of -20.0% and a 95% CI of [-26.8%; -8.9%] (Full Analysis Set), and were 27.7% in control arm and 9.8% in the new cross-linked hyaluronan hydrogel arm with a difference of -14.4% and a 95% CI of [-20.6%; -2.6%] (Per Protocol Set). There were no serious adverse events reported and the safety profile of HyaRegen gel was comparable to that of saline placebo. Conclusion: The present study shows this new cross-linked hyaluronan hydrogel is safe and efficacious in the reduction of postsurgical adhesions throughout abdominopelvic cavity. 199
Open Communications 9 - New Instruments (11:42 AM - 11:47 AM)
Fibroid Symptom Reduction, Health-Related Quality of Life Improvement and Patient Satisfaction after Radiofrequency Ablation of Uterine Fibroids with the VizAblateÒ System Garza-Leal JG,1 Gupta J,2 Bongers M,3 Br€olmann H,4 Quartero R,5 Veersema S,6 Toub DB.7 1Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Le on, Mexico; 2Birmingham Women’s Hospital, Birmingham, United Kingdom; 3Maxima Medisch Centrum, Veldhoven, Netherlands; 4Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands; 5Medisch Spectrum Twente, Enschede, Netherlands; 6Sint Antonius Ziekenhuis, Nieuwegein, Netherlands; 7Gynesonics, Inc., Redwood City, California Study Objective: To determine improvement in fibroid symptoms and health-related quality of life (HRQOL) along with patient satisfaction after treatment of symptomatic fibroids using the VizAblate System. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: Several academic and community hospitals in the United Kingdom, The Netherlands and Mexico. Patients: Up to 100 women with heavy menstrual bleeding secondary to fibroids. A sample of 40 subjects was sufficient to detect a difference of 22% in the probability of success with a power of 82% using a one-group chi-square test with a 0.05 two-sided significance level. Intervention: Transcervical, intrauterine ultrasound-guided radiofrequency ablation performed on up to 5 fibroids per subject ranging from 1-5 cm in diameter. Measurements and Main Results: Data are for the first 50 treated subjects as of April, 2014. Subjects completed the Uterine Fibroid Symptom and Quality of Life questionnaire and satisfaction was reported using a 5point Likert scale. At baseline (n = 50), the median Symptom Severity Score (SSS) was 61.0 (range; 28.0-100.0) and the median HRQOL was 32.0 (range; 1.0-73.0). At 6 months, the median SSS (n = 49) fell to 19 (range; 0.0-78.0), a 66.1% improvement; median HRQOL (n = 48) increased to 85 (range; 1.0-100.0), a 118.9% improvement. At 12 months (n = 43), median SSS decreased further to 16.0 (range; 0.0-75.0), a 75.8%
improvement; median HRQOL rose higher to 93.0 (range; 28.0-100.0), a 158.8% improvement. At 6 months, 43 of 47 (91.5%) subjects were satisfied with the procedure; 36 of 39 subjects (92.3%) expressed satisfaction at 12 months. Conclusion: Radiofrequency ablation using the VizAblate System provides significant improvements in symptom relief and health-related quality of life, with patients reporting very high levels of satisfaction with their outcomes. 200
Open Communications 9 - New Instruments (11:48 AM - 11:53 AM)
OvalasticÒ: 1st Experience with a New Hysteroscopic Sterilization System Thurkow AL. Ob/Gyn Minimal Invasive Surgery, St. Lucas Andreas Hospital, Amsterdam, NH, Netherlands Study Objective: The first clinical experience with a new device for hysteroscopic sterilization will be presented. Hysteroscopic sterilization has become the standard of care in many countries, due to the ease of use, speed and reliability of the only remaining current device (EssureÒ). In Europe recently a new alternative system received a CE mark: OvalasticÒ. It is an improved evolution from a hysteroscopic sterilization system that actually has a very long history: OvablocÒ, studied in the US in the 70’s and received CE marking in 1990. Both systems consist of a formed-in-place liquid siloxane material inserted by a catheter through the working channel of a hysteroscope. Design: In an observational clinical pilot study the first clinical data with this new version from centers in the Netherlands and in Poland will be presented with a follow-up period ranging from 2 to 36 months. Setting: Ambulatory or conscious sedation in daycare setting. Patients: 15 patients were treated, selection was based on patient preference or contra-indications for Essure sterilization. Intervention: Hysteroscopic Sterilization with Ovalastic formed-in-place silicone material. Measurements and Main Results: The study showed the feasibility of ambulatory sterilization with this device. The overall bilateral placement rate was 79%, failures were related to the learning curve and initial technical imperfections. There was one non-relying pregnancy in a patient who did not comply with the advice to use additional contraception until the confirmation test after 3 months. Conclusion: The study showed the feasibility of ambulatory sterilization with this device. Possible advantages of Ovalastic over other systems include: - inert material, therefore no tissue ingrowth (or adhesions in case of inadvertent perforation) - a soft silicone plug - no nickel - lower cost of material More clinical data are needed, which will be provided in a prospective multicenter clinical study, that is expected to start end of 2014. 201
Open Communications 9 - New Instruments (11:54 AM - 11:59 AM)
Real Time Haptic Feedback in Endoscopy; Dreams Become Reality? The State of Art Vleugels MPH,1 Nieboer B.2 Obstetrics and Gynecology, Riverland Hospital, Tiel, Gelderland, Netherlands; 2Obstetrics and Gynecology, University Medical Center Radboud, Nijmegen, Gelderland, Netherlands Study Objective: Laparoscopic Instruments, conventional and robotic, lack real time haptic feedback due to the high friction of the instruments and low accuracy; no tissue information and no control of the gripping forces is delivered. Our current objective is development of laparoscopic instruments with haptic feedback which are affordable and applicable in all endoscopic operations. Ultimately, this will enhance patient safety and ergonomics for surgeons.