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14: Procedural Characteristics of the Adiana Transcervical Sterilization System
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Journal of Minimally Invasive Gynecology, Vol 14, No 6, November/December Supplement 2007
modeling, non-human tissue, and extirpated human uterine tissue. Setting: University Medical Center and Corporate Basic Research Facility. Patients: All extirpated human uterine tissue used in this study was obtained and utilized by exemption from the IRB. Intervention: The morcellator connects to the Gyrus ACMI G400 generator. This system was used to morcellate nonhuman (beef heart and tongue) and human (fibroid and non-fibroid uterus) tissue in a pig laparoscopy model as well as in bench studies. Cutting efficiency, thermal characteristics, and tissue effects were evaluated in vivo, and in vitro, using bench modeling. Device and tissue thermal profiles were evaluated using infrared photography and thermocouple measurements. Measurements and Main Results: The PKS Plasma Morcellator is a bladeless device driven by PK Technology. All tissue types cut with equally minimal resistance, including soft, dense, and calcified fibroids. There was no reduction in cutting efficiency with time due to a dulling blade. The dedicated grasper completes the bipolar circuit during the initial phase of tissue morcellation and otherwise manipulates tissue effectively. Electrothermal effect on cut tissue was insignificant when examined histologically. Device tip temperature was measured after multiple activation cycles (8 seconds on / 9 seconds off) continued up to 10 minutes. Tip temperature reached a maximum of 140 C with rapid exponential cooling. Touching the tip to viable tissue (bowel) immediately after morcellation cycles failed to result in thermal injury. Conclusion: The PKS Plasma Morcellator is an ergonomically designed instrument that can be used to remove tissue of a wide range of consistencies during laparoscopy. The absence of a sharp blade should offer a margin of safety during laparoscopic use. 14 Procedural Characteristics of the Adiana Transcervical Sterilization System 1 Anderson TL, 2Presthus J. 1Nashville, Tennessee; 2 Minnesota Gynecology and Surgery, Edina, Minnesota Study Objective: To evaluate the procedural characteristics of the Adiana Transcervical Sterilization System. Design: Multicenter prospective clinical trial involving 15 sites in the US, Mexico, and Australia. Setting: Procedures were conducted at university and private hospitals. Patients: All clinical sites were in full compliance of a local or central IRB. The intent-to-treat population of 645 women ranged in age from 20-45. Intervention: Enrolled patients underwent hysteroscopy using glycine insufflation. Paracervical block and/or varied levels of i.v. sedation was achieved, depending on patient or investigator preference. Delivery catheters were introduced sequentially into each Fallopian tube under direct visualiza-
tion. Bipolar RF energy was delivered and the silicone matrix deposited fully within the tubal lumen. Measurements and Main Results: Catheters were easily threaded into the tubes. Matrix delivery was accomplished by a push-button mechanism. Successful bilateral placement was accomplished in 94.7% of patients. The mean time required to complete the procedure was 11:54 minutes. The mean glycine volume used was 1226 mL, with a mean fluid absorption of 182 mL. Local anesthesia was used in 53.2% of cases with moderate sedation in 46.8% of procedures. Using a visual analog scale, 40.2% of patients reported very little or no discomfort during the procedure; only 9.2% described it as very uncomfortable. Narcotic analgesia use immediately postoperatively was 17.2%, which dropped to 1.2% by postoperative day 1. Most patients (89.5%) resumed normal activities in 1 day or less. Conclusion: The Adiana Transcervical Sterilization System was easily and rapidly deployed by the investigators in this trial. It was well-tolerated and accepted by patients. The absence of metal or device components remaining in the cavity should offer the significant advantage of maximizing potential future diagnostic and therapeutic intrauterine procedures.
15 Recurrent Pain After Surgical Treatment for Endometriosis. A Randomized Controlled Study Comparing Four Medical Approaches Angioni S, Ariu F. University of Cagliari, Cagliari, Italy Study Objective: To evaluate the efficacy, safety and tolerability of four medical approaches in the treatment of recurrent pain after surgery for symptomatic endometriosis. Design: Randomized controlled trial. Setting: Three tertiary referral centers for the treatment of endometriosis. Patients: One hundred forty women with recurrent moderate or severe pelvic pain after conservative treatment for symptomatic endometriosis. Intervention: Twelve month treatment with: a) cyclic estrogen-progestogen combination; b) continuous estrogenprogestogen combination; c) GnRH analogue (GnRHa); d GnRHa plus tibolone. Measurements and Main Results: Degree of satisfaction with therapy and Pain scores questionnaires evaluation. Twenty women in the cyclic estrogen-progestogen combination withdrew because of treatment inefficacy and/or side effects. At 6 and 12 months, dysmenorrhea, deep dyspareunia, nonmenstrual pelvic pain and dyschezia scores were reduced with the best results in the GnRHa and GnRHa plus tibolone arms. Conclusion: Medical therapy could be considered an effective alternative to repeat surgery for treating symptomatic endometriosis in patients who do not seek conception.
Journal of Minimally Invasive Gynecology, Vol 14, No 6, November/December Supplement 2007
modeling, non-human tissue, and extirpated human uterine tissue. Setting: University Medical Center and Corporate Basic Research Facility. Patients: All extirpated human uterine tissue used in this study was obtained and utilized by exemption from the IRB. Intervention: The morcellator connects to the Gyrus ACMI G400 generator. This system was used to morcellate nonhuman (beef heart and tongue) and human (fibroid and non-fibroid uterus) tissue in a pig laparoscopy model as well as in bench studies. Cutting efficiency, thermal characteristics, and tissue effects were evaluated in vivo, and in vitro, using bench modeling. Device and tissue thermal profiles were evaluated using infrared photography and thermocouple measurements. Measurements and Main Results: The PKS Plasma Morcellator is a bladeless device driven by PK Technology. All tissue types cut with equally minimal resistance, including soft, dense, and calcified fibroids. There was no reduction in cutting efficiency with time due to a dulling blade. The dedicated grasper completes the bipolar circuit during the initial phase of tissue morcellation and otherwise manipulates tissue effectively. Electrothermal effect on cut tissue was insignificant when examined histologically. Device tip temperature was measured after multiple activation cycles (8 seconds on / 9 seconds off) continued up to 10 minutes. Tip temperature reached a maximum of 140 C with rapid exponential cooling. Touching the tip to viable tissue (bowel) immediately after morcellation cycles failed to result in thermal injury. Conclusion: The PKS Plasma Morcellator is an ergonomically designed instrument that can be used to remove tissue of a wide range of consistencies during laparoscopy. The absence of a sharp blade should offer a margin of safety during laparoscopic use. 14 Procedural Characteristics of the Adiana Transcervical Sterilization System 1 Anderson TL, 2Presthus J. 1Nashville, Tennessee; 2 Minnesota Gynecology and Surgery, Edina, Minnesota Study Objective: To evaluate the procedural characteristics of the Adiana Transcervical Sterilization System. Design: Multicenter prospective clinical trial involving 15 sites in the US, Mexico, and Australia. Setting: Procedures were conducted at university and private hospitals. Patients: All clinical sites were in full compliance of a local or central IRB. The intent-to-treat population of 645 women ranged in age from 20-45. Intervention: Enrolled patients underwent hysteroscopy using glycine insufflation. Paracervical block and/or varied levels of i.v. sedation was achieved, depending on patient or investigator preference. Delivery catheters were introduced sequentially into each Fallopian tube under direct visualiza-
tion. Bipolar RF energy was delivered and the silicone matrix deposited fully within the tubal lumen. Measurements and Main Results: Catheters were easily threaded into the tubes. Matrix delivery was accomplished by a push-button mechanism. Successful bilateral placement was accomplished in 94.7% of patients. The mean time required to complete the procedure was 11:54 minutes. The mean glycine volume used was 1226 mL, with a mean fluid absorption of 182 mL. Local anesthesia was used in 53.2% of cases with moderate sedation in 46.8% of procedures. Using a visual analog scale, 40.2% of patients reported very little or no discomfort during the procedure; only 9.2% described it as very uncomfortable. Narcotic analgesia use immediately postoperatively was 17.2%, which dropped to 1.2% by postoperative day 1. Most patients (89.5%) resumed normal activities in 1 day or less. Conclusion: The Adiana Transcervical Sterilization System was easily and rapidly deployed by the investigators in this trial. It was well-tolerated and accepted by patients. The absence of metal or device components remaining in the cavity should offer the significant advantage of maximizing potential future diagnostic and therapeutic intrauterine procedures.
15 Recurrent Pain After Surgical Treatment for Endometriosis. A Randomized Controlled Study Comparing Four Medical Approaches Angioni S, Ariu F. University of Cagliari, Cagliari, Italy Study Objective: To evaluate the efficacy, safety and tolerability of four medical approaches in the treatment of recurrent pain after surgery for symptomatic endometriosis. Design: Randomized controlled trial. Setting: Three tertiary referral centers for the treatment of endometriosis. Patients: One hundred forty women with recurrent moderate or severe pelvic pain after conservative treatment for symptomatic endometriosis. Intervention: Twelve month treatment with: a) cyclic estrogen-progestogen combination; b) continuous estrogenprogestogen combination; c) GnRH analogue (GnRHa); d GnRHa plus tibolone. Measurements and Main Results: Degree of satisfaction with therapy and Pain scores questionnaires evaluation. Twenty women in the cyclic estrogen-progestogen combination withdrew because of treatment inefficacy and/or side effects. At 6 and 12 months, dysmenorrhea, deep dyspareunia, nonmenstrual pelvic pain and dyschezia scores were reduced with the best results in the GnRHa and GnRHa plus tibolone arms. Conclusion: Medical therapy could be considered an effective alternative to repeat surgery for treating symptomatic endometriosis in patients who do not seek conception.