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Variation of Antimullerian Hormone Level after Endometrioma Ablation Using Plasma Energy
S88 292
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90 Open Communications 16 - New Instruments (2:15 PM - 2:20 PM)
ALEEP (Abdominal Loop Electrical Excision Procedure) – A Newly Developed Instrument to Reduce Post-Operative Cervical Bleeding in LASH Procedure Patients Deckardt R,1 Roth A.2 1Gynecology, DESA Clinic, Munich, Bavaria, Germany; 2Gynecology, DESA Clinic, Munich, Bavaria, Germany Study Objective: Laparoscopically assisted supracervical hysterectomy (LASH) has gained in incidence with benign diseases of the uterus undergoing hysterectomy. Besides the multiple clinical benefits of this procedure to the patient, the remaining cervical stump my cause problems, which may reduce patient satisfaction and in some even necessitates further surgical intervention. One problem of LASH is postoperative bleeding from the cervical stump. The cause of this complication is not completely understood but likely due to remaining endometrial tissue in the preserved cervix. The incidence ranges from \1% to 25%. To prevent post-op bleeding following LASH, different measures have been suggested.Bipolar coagulation of the endocervical canal is being performed routinely in most centers, excision of the endocervix in some.To minimize the incidence of post-operative bleeding, we developed a newly designed resection electrode. This electrode is being inserted through one of the 5 mm trocar sites and connected to monopolar current. The tip of the electrode is inserted into the abdominal part of the endocervical canal where the depth of insertion is marked on the instrument. The loop shape of the abdominal resection tool (ALEEP) is designed to secure sufficient tissue gain in either vertical and horizontal direction. The harvested tissue cylinder is sent separately to histology. It is our understanding that use of this newly developed resection tool offers some distinct advantages as compared to other procedures in order to reduce post-operative bleeding. The resection is performed under direct vision as compared to blind bipolar coagulation, histology of the endocervix is being gained, there is little thermal damage to the cervix. The resection is quick and requires no further equipment besides the electrode. 293
Open Communications 16 - New Instruments (2:21 PM - 2:26 PM)
comparative analysis would have increased satisfaction clinically and economically. Design: Testing and analysis was done comparing various commercially available trocar/cannulas and smoke evacuation devices with the LEXION Medical VeryClear Port. Evaluations were done for smoke evacuation efficiency, room smoke contamination and spatial removal characteristics. Setting: Research laboratory. Intervention: Laboratory analysis. Measurements and Main Results: Statistically significantly findings (p\0.01) were higher evacuation flow rates (up to 78% improvement), lower pressure drop (up to 70% improvement), radial smoke removal compared to distal only and lower room contamination concentration through the Synergy Port compared to the others. Conclusion: Cannula design architecture significantly improves gas removal characteristics related to increased smoke evacuation rate, radial capture, maintenance of pneumoperitoneum and cost effectiveness. This is accomplished only with the VeryClear Port. 294
Open Communications 16 - New Instruments (2:27 PM - 2:32 PM)
Variation of Antimullerian Hormone Level after Endometrioma Ablation Using Plasma Energy Roman H, Auber M. Gynecology and Obstetrics, Rouen University Hospital, Rouen, Seine Maritime, France Study Objective: To investigate the impact of ovarian endometrioma vaporization using plasma energy on antimullerian hormone (AMH) level. Design: We report a prospective, non comparative series (NCT01596985) of patients enrolled during the period of November 2010 to November 2012. The mean length of postoperative follow-up was 18.2 8 months. AMH levels were assessed before surgery, 3 months postoperatively and at the end of follow-up. Setting: Rouen University Hospital. Patients: Twenty two patients with unilateral ovarian endometriomas >=30 mm, with no surgical antecedent and no ongoing pregnancy were enrolled in the study. Intervention: Vaporization of ovarian endometriomas using PlasmaJetÒ.
Laparoscopic Smoke Evacuation: A Comparative Analysis Ott DE,1 Michal B.2 1Biomedical Engineering, Mercer University, Macon, Georgia; 2Engineering, LEXION Medical, St. Paul, Minnesota Study Objective: Surgical smoke removal during laparoscopic procedures is paramount for vision and reduction of toxic exposure from combustion by-products for patients, surgeons and staff health and safety. Regulations, mandates, scientific studies and recommendations are in place but products claim to be effective have flaws or drawbacks causing continued risk and exposure to smoke. Designing a useful device meeting patients, science and cost conscious health professional requirements incorporating efficient smoke removal capability and port access functionality at the same time is a long standing need. The physical structure and design attributes of a cannula for laparoscopic access with continuous smoke evacuation capability is the focus of this analysis. All laparoscopic cannulas except Synergy are hollow tubes top to bottom. A gas evacuation access port with multiple distal perforations for continuous gas suctioning combining instrument access answers the surgical and cost need simultaneously. It was hypothesized that this configuration in a
Measurements and Main Results: We assessed AMH levels before surgery, 3 months postoperatively and at the end of follow-up.
AMH values before and after surgery.
Number of patients with AMH assessment Median AMH value (ng/mL) 25th and 75th percentiles of median AMH value (ng/mL) 95% CI of median AMH value (ng/mL)
Preoperative
3 months after surgery
Third assessment
P
22 3.2 2.2;5.2 2.2; 5.2
22 2.2 1.9; 2.8 2; 2.8
21 2.7 1.9; 3.4 1.9; 3.4
0.001
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90 AMH level significantly varied through the three assessments performed in the study, as the mean valuesSD were 3.9 2.6 ng/ml before the surgery, 2.3 1.1 ng/ml at 3 months and 3.1 2.2 ng/ml at the end of the follow up (P=0.001). There was a significant increase from 3 months postoperatively to the end of follow up (median change 0.7 ng/mL, P=0.01). 71% of patients had an AMH level >2 ng/mL at the end of the follow up vs. 76% before the surgery (P=1). During the postoperative follow up, eleven patients tried to conceive, of whom eight became pregnant (73%). Ultrasound assessment revealed no endometriomas recurrences at the end of the follow up. Conclusion: The ablation of unilateral endometriomas is followed in a majority of cases by a significant decrease in AMH level 3 months after surgery. In subsequent months this level progressively increases, raising questions about the real factors that impact postoperative ovarian AMH production. 295
Open Communications 16 - New Instruments (2:33 PM - 2:38 PM)
A New and Novel Method for Tissue Extraction In Laparoscopic Surgery Zisow DL. Minimally Invasive Surgery & Gynecology, Northwest Hospital, Randallstown, Maryland Study Objective: The development of a method and equipment for tissue extraction from the abdominal/pelvic cavities during total laparoscopic hysterectomy that prevents dispersion of pathologic tissues inside the body cavity. Setting: Community Hospital. Patients: Women undergoing total laparoscopic hysterectomy involving uteri too large to be removed transvaginally intact therefore requiring some method of intracavitary morcellation. Intervention: At the time of total laparoscopic hysterectomy the surgeon performs the procedure as usual to the point where the surgical specimen is free of all bodily attachments and residing within the abdominal/pelvic cavity. Transvaginal extraction is the method of choice, but if the specimen is too large, morcellation is required to avoid a large abdominal incision. If the latter is the case, a new bag device is inserted transvaginally allowing easy placement of the entire specimen within the bag. This bag has a self opening feature that opens to a diameter of 20 cm and a capacity sufficient for a 2000 gm uterine specimen. Once in the bag, the open end is exteriorized through any 3 cm diameter abdominal incision (usually at the umbilicus) and the contents are removed using the ‘‘Paper Roll’’ morcellation method without any loss of tissues in the peritoneal cavity. Development of a new mechanical morcellator system designed to be used in combination with the above bag is in process and will avoid the need for ‘‘Paper Roll’’ morcellation. Conclusion: A unique and new method for bagging large tissue specimens is being introduced. Recent highly publicized concerns regarding peritoneal spread of a sarcoma during morcellation prompted the recognition that better methods of tissue isolation during extraction are needed and can be made easily available. A video submission is anticipated to accompany this presentation. 296
Open Communications 16 - New Instruments (2:39 PM - 2:44 PM)
Optical Imaging Falloposcope for Minimally Invasive Ovarian Cancer Detection Keenan MR,1 Tate T,2 Swan E,2 Black J,3 Utzinger U,1 Barton JK.1 1 Biomedical Engineering, The University of Arizona, Tucson, Arizona; 2 College of Optical Sciences, The University of Arizona, Tucson, Arizona; 3 Glannaventa, San Mateo, California Study Objective: To develop a multi-modal endoscope to screen the human Fallopian tubes and ovaries for ovarian cancer. Design: We are combining multispectral fluorescence imaging (MFI) and optical coherence tomography (OCT) into a 0.6mm outer diameter endoscope. An endoscope of this size can be introduced to the fallopian tubes transvaginally, creating a minimally invasive screening method for
S89
high risk women. We have previously shown that multispectral imaging utilizing the endogenous fluorescence of the tissue can improve lesion contrast in ex vivo samples. In addition, OCT can identify structural differences between normal, benign cysts and adenocarcinoma in human ovary surgical samples. Setting: University lab and hospital. Patients: Examine ex vivo ovary and fallopian tube surgical samples from 20 consented patients. Measurements and Main Results: The proximal optics, which couples five beam paths from four lasers covering a range of 255 to 638nm, has been completed. These beams will couple to the distal MFI illumination fiber, a 125um diameter single mode fiber. The custom MFI objective will image a circle with diameter of 3mm on the tissue to a 3,000 element fiber bundle. This will relay the reflectance and fluorescence images to the camera. Optical design and simulation has been performed in Zemax for forward viewing MFI imaging optics. Side-viewing OCT will be collected as an A-scan. A steering wire will allow the tip to be bent in one direction. Conclusion: Work on construction of the distal tip will begin in the summer. Optical screening of the ovary through a natural orifice appears to be feasible. 297
Open Communications 16 - New Instruments (2:45 PM - 2:50 PM)
Use of a New Instrument in the Management of Total Laparoscopic Radical Hysterectomy (TLRH) Barletta F,1 Corrado G,2 Vizza E.2 1Gynecology and Obstetrics Unit, San Giovanni Hospital, Rome, Italy; 2Oncological Surgery, Gynecologic Oncologic Unit, National Cancer Institute, Rome, Italy Study Objective: To evaluate safety and efficacy of a modified tenaculum called SNAIL ( Simple Nebs Arising Incision Landmark ) for gynecological oncologic surgery. Design: Prospective, single center, feasibility study. Setting: Division of Gynecology Oncology, National Cancer Institute. Patients: Women undergoing TLRH for endometrial and cervical cancer. Intervention: This invention origins by a surgical reusable instrument named Uterine Tenaculum Forceps , model Schroder , code 32-622-25 of Martin catalogue. This tenaculum is modified adding two nebs 1-2 cm of distance from the tips of the instrument. The nebs are 1 cm each and widen whith a 90 degrees angle between them. They can be perpendicular to main axis of instrument or forming with latter 45-60 degrees angle bent forward. In order to preserve an adequate pneumoperitoneum during colpotomy a medical grade silicon balloon, named colpo-pneumo occluder (Cooper Surgical) is placed in vagina. Measurements and Main Results: We used SNAIL Tenaculum in 32 patients for early endometrial and cervical cancer. During the procedure the nebs were always under vision also in obese patients. The average length of circular vagina removed with the uterus was 21 mm (range 1040mm). None intraoperative complication were registered. Conclusion: At present the risk of perforation, lympho-vascular spaces involvement (LVSI) and positive peritoneal cytology by uterine manipulation is still debated. We found SNAIL tenaculum to be a safe and efficient tool for patients who undergoing TLRH since it eliminates risks of perforation, LVSI and positivization of peritoneal cytology, maintaining same chances of uterine mobility. Also the nebs allow surgeon to choose the length of vaginal wall to be removed modulating, proximally or distally to them, the incision line. Last, but not least, must be said SNAIL tenaculum combines the ease of use of a very familiar instrument to gynecologists, with the lowest cost so far recorded. 298
Open Communications 16 - New Instruments (2:51 PM - 2:56 PM)
A Comparison of Physician-Rated Performance Characteristics, Preference and Ease of Use for the MyoSureÒ Hysteroscopic Morcellator Providing a Suction on Demand Feature for Visualization of the Uterine Cavity Scheiber MD. Institute for Reproductive Health, Cincinnati, Ohio
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90 Open Communications 16 - New Instruments (2:15 PM - 2:20 PM)
ALEEP (Abdominal Loop Electrical Excision Procedure) – A Newly Developed Instrument to Reduce Post-Operative Cervical Bleeding in LASH Procedure Patients Deckardt R,1 Roth A.2 1Gynecology, DESA Clinic, Munich, Bavaria, Germany; 2Gynecology, DESA Clinic, Munich, Bavaria, Germany Study Objective: Laparoscopically assisted supracervical hysterectomy (LASH) has gained in incidence with benign diseases of the uterus undergoing hysterectomy. Besides the multiple clinical benefits of this procedure to the patient, the remaining cervical stump my cause problems, which may reduce patient satisfaction and in some even necessitates further surgical intervention. One problem of LASH is postoperative bleeding from the cervical stump. The cause of this complication is not completely understood but likely due to remaining endometrial tissue in the preserved cervix. The incidence ranges from \1% to 25%. To prevent post-op bleeding following LASH, different measures have been suggested.Bipolar coagulation of the endocervical canal is being performed routinely in most centers, excision of the endocervix in some.To minimize the incidence of post-operative bleeding, we developed a newly designed resection electrode. This electrode is being inserted through one of the 5 mm trocar sites and connected to monopolar current. The tip of the electrode is inserted into the abdominal part of the endocervical canal where the depth of insertion is marked on the instrument. The loop shape of the abdominal resection tool (ALEEP) is designed to secure sufficient tissue gain in either vertical and horizontal direction. The harvested tissue cylinder is sent separately to histology. It is our understanding that use of this newly developed resection tool offers some distinct advantages as compared to other procedures in order to reduce post-operative bleeding. The resection is performed under direct vision as compared to blind bipolar coagulation, histology of the endocervix is being gained, there is little thermal damage to the cervix. The resection is quick and requires no further equipment besides the electrode. 293
Open Communications 16 - New Instruments (2:21 PM - 2:26 PM)
comparative analysis would have increased satisfaction clinically and economically. Design: Testing and analysis was done comparing various commercially available trocar/cannulas and smoke evacuation devices with the LEXION Medical VeryClear Port. Evaluations were done for smoke evacuation efficiency, room smoke contamination and spatial removal characteristics. Setting: Research laboratory. Intervention: Laboratory analysis. Measurements and Main Results: Statistically significantly findings (p\0.01) were higher evacuation flow rates (up to 78% improvement), lower pressure drop (up to 70% improvement), radial smoke removal compared to distal only and lower room contamination concentration through the Synergy Port compared to the others. Conclusion: Cannula design architecture significantly improves gas removal characteristics related to increased smoke evacuation rate, radial capture, maintenance of pneumoperitoneum and cost effectiveness. This is accomplished only with the VeryClear Port. 294
Open Communications 16 - New Instruments (2:27 PM - 2:32 PM)
Variation of Antimullerian Hormone Level after Endometrioma Ablation Using Plasma Energy Roman H, Auber M. Gynecology and Obstetrics, Rouen University Hospital, Rouen, Seine Maritime, France Study Objective: To investigate the impact of ovarian endometrioma vaporization using plasma energy on antimullerian hormone (AMH) level. Design: We report a prospective, non comparative series (NCT01596985) of patients enrolled during the period of November 2010 to November 2012. The mean length of postoperative follow-up was 18.2 8 months. AMH levels were assessed before surgery, 3 months postoperatively and at the end of follow-up. Setting: Rouen University Hospital. Patients: Twenty two patients with unilateral ovarian endometriomas >=30 mm, with no surgical antecedent and no ongoing pregnancy were enrolled in the study. Intervention: Vaporization of ovarian endometriomas using PlasmaJetÒ.
Laparoscopic Smoke Evacuation: A Comparative Analysis Ott DE,1 Michal B.2 1Biomedical Engineering, Mercer University, Macon, Georgia; 2Engineering, LEXION Medical, St. Paul, Minnesota Study Objective: Surgical smoke removal during laparoscopic procedures is paramount for vision and reduction of toxic exposure from combustion by-products for patients, surgeons and staff health and safety. Regulations, mandates, scientific studies and recommendations are in place but products claim to be effective have flaws or drawbacks causing continued risk and exposure to smoke. Designing a useful device meeting patients, science and cost conscious health professional requirements incorporating efficient smoke removal capability and port access functionality at the same time is a long standing need. The physical structure and design attributes of a cannula for laparoscopic access with continuous smoke evacuation capability is the focus of this analysis. All laparoscopic cannulas except Synergy are hollow tubes top to bottom. A gas evacuation access port with multiple distal perforations for continuous gas suctioning combining instrument access answers the surgical and cost need simultaneously. It was hypothesized that this configuration in a
Measurements and Main Results: We assessed AMH levels before surgery, 3 months postoperatively and at the end of follow-up.
AMH values before and after surgery.
Number of patients with AMH assessment Median AMH value (ng/mL) 25th and 75th percentiles of median AMH value (ng/mL) 95% CI of median AMH value (ng/mL)
Preoperative
3 months after surgery
Third assessment
P
22 3.2 2.2;5.2 2.2; 5.2
22 2.2 1.9; 2.8 2; 2.8
21 2.7 1.9; 3.4 1.9; 3.4
0.001
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S45–S90 AMH level significantly varied through the three assessments performed in the study, as the mean valuesSD were 3.9 2.6 ng/ml before the surgery, 2.3 1.1 ng/ml at 3 months and 3.1 2.2 ng/ml at the end of the follow up (P=0.001). There was a significant increase from 3 months postoperatively to the end of follow up (median change 0.7 ng/mL, P=0.01). 71% of patients had an AMH level >2 ng/mL at the end of the follow up vs. 76% before the surgery (P=1). During the postoperative follow up, eleven patients tried to conceive, of whom eight became pregnant (73%). Ultrasound assessment revealed no endometriomas recurrences at the end of the follow up. Conclusion: The ablation of unilateral endometriomas is followed in a majority of cases by a significant decrease in AMH level 3 months after surgery. In subsequent months this level progressively increases, raising questions about the real factors that impact postoperative ovarian AMH production. 295
Open Communications 16 - New Instruments (2:33 PM - 2:38 PM)
A New and Novel Method for Tissue Extraction In Laparoscopic Surgery Zisow DL. Minimally Invasive Surgery & Gynecology, Northwest Hospital, Randallstown, Maryland Study Objective: The development of a method and equipment for tissue extraction from the abdominal/pelvic cavities during total laparoscopic hysterectomy that prevents dispersion of pathologic tissues inside the body cavity. Setting: Community Hospital. Patients: Women undergoing total laparoscopic hysterectomy involving uteri too large to be removed transvaginally intact therefore requiring some method of intracavitary morcellation. Intervention: At the time of total laparoscopic hysterectomy the surgeon performs the procedure as usual to the point where the surgical specimen is free of all bodily attachments and residing within the abdominal/pelvic cavity. Transvaginal extraction is the method of choice, but if the specimen is too large, morcellation is required to avoid a large abdominal incision. If the latter is the case, a new bag device is inserted transvaginally allowing easy placement of the entire specimen within the bag. This bag has a self opening feature that opens to a diameter of 20 cm and a capacity sufficient for a 2000 gm uterine specimen. Once in the bag, the open end is exteriorized through any 3 cm diameter abdominal incision (usually at the umbilicus) and the contents are removed using the ‘‘Paper Roll’’ morcellation method without any loss of tissues in the peritoneal cavity. Development of a new mechanical morcellator system designed to be used in combination with the above bag is in process and will avoid the need for ‘‘Paper Roll’’ morcellation. Conclusion: A unique and new method for bagging large tissue specimens is being introduced. Recent highly publicized concerns regarding peritoneal spread of a sarcoma during morcellation prompted the recognition that better methods of tissue isolation during extraction are needed and can be made easily available. A video submission is anticipated to accompany this presentation. 296
Open Communications 16 - New Instruments (2:39 PM - 2:44 PM)
Optical Imaging Falloposcope for Minimally Invasive Ovarian Cancer Detection Keenan MR,1 Tate T,2 Swan E,2 Black J,3 Utzinger U,1 Barton JK.1 1 Biomedical Engineering, The University of Arizona, Tucson, Arizona; 2 College of Optical Sciences, The University of Arizona, Tucson, Arizona; 3 Glannaventa, San Mateo, California Study Objective: To develop a multi-modal endoscope to screen the human Fallopian tubes and ovaries for ovarian cancer. Design: We are combining multispectral fluorescence imaging (MFI) and optical coherence tomography (OCT) into a 0.6mm outer diameter endoscope. An endoscope of this size can be introduced to the fallopian tubes transvaginally, creating a minimally invasive screening method for
S89
high risk women. We have previously shown that multispectral imaging utilizing the endogenous fluorescence of the tissue can improve lesion contrast in ex vivo samples. In addition, OCT can identify structural differences between normal, benign cysts and adenocarcinoma in human ovary surgical samples. Setting: University lab and hospital. Patients: Examine ex vivo ovary and fallopian tube surgical samples from 20 consented patients. Measurements and Main Results: The proximal optics, which couples five beam paths from four lasers covering a range of 255 to 638nm, has been completed. These beams will couple to the distal MFI illumination fiber, a 125um diameter single mode fiber. The custom MFI objective will image a circle with diameter of 3mm on the tissue to a 3,000 element fiber bundle. This will relay the reflectance and fluorescence images to the camera. Optical design and simulation has been performed in Zemax for forward viewing MFI imaging optics. Side-viewing OCT will be collected as an A-scan. A steering wire will allow the tip to be bent in one direction. Conclusion: Work on construction of the distal tip will begin in the summer. Optical screening of the ovary through a natural orifice appears to be feasible. 297
Open Communications 16 - New Instruments (2:45 PM - 2:50 PM)
Use of a New Instrument in the Management of Total Laparoscopic Radical Hysterectomy (TLRH) Barletta F,1 Corrado G,2 Vizza E.2 1Gynecology and Obstetrics Unit, San Giovanni Hospital, Rome, Italy; 2Oncological Surgery, Gynecologic Oncologic Unit, National Cancer Institute, Rome, Italy Study Objective: To evaluate safety and efficacy of a modified tenaculum called SNAIL ( Simple Nebs Arising Incision Landmark ) for gynecological oncologic surgery. Design: Prospective, single center, feasibility study. Setting: Division of Gynecology Oncology, National Cancer Institute. Patients: Women undergoing TLRH for endometrial and cervical cancer. Intervention: This invention origins by a surgical reusable instrument named Uterine Tenaculum Forceps , model Schroder , code 32-622-25 of Martin catalogue. This tenaculum is modified adding two nebs 1-2 cm of distance from the tips of the instrument. The nebs are 1 cm each and widen whith a 90 degrees angle between them. They can be perpendicular to main axis of instrument or forming with latter 45-60 degrees angle bent forward. In order to preserve an adequate pneumoperitoneum during colpotomy a medical grade silicon balloon, named colpo-pneumo occluder (Cooper Surgical) is placed in vagina. Measurements and Main Results: We used SNAIL Tenaculum in 32 patients for early endometrial and cervical cancer. During the procedure the nebs were always under vision also in obese patients. The average length of circular vagina removed with the uterus was 21 mm (range 1040mm). None intraoperative complication were registered. Conclusion: At present the risk of perforation, lympho-vascular spaces involvement (LVSI) and positive peritoneal cytology by uterine manipulation is still debated. We found SNAIL tenaculum to be a safe and efficient tool for patients who undergoing TLRH since it eliminates risks of perforation, LVSI and positivization of peritoneal cytology, maintaining same chances of uterine mobility. Also the nebs allow surgeon to choose the length of vaginal wall to be removed modulating, proximally or distally to them, the incision line. Last, but not least, must be said SNAIL tenaculum combines the ease of use of a very familiar instrument to gynecologists, with the lowest cost so far recorded. 298
Open Communications 16 - New Instruments (2:51 PM - 2:56 PM)
A Comparison of Physician-Rated Performance Characteristics, Preference and Ease of Use for the MyoSureÒ Hysteroscopic Morcellator Providing a Suction on Demand Feature for Visualization of the Uterine Cavity Scheiber MD. Institute for Reproductive Health, Cincinnati, Ohio