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ALEEP (Abdominal Loop Electrical Excision Procedure) – A Newly Developed Instrument to Reduce Post-Operative Cervical Bleeding in LASH Procedure Patients
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 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