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Feasibility and Safety of a Minimally Invasive Surgical (MIS) Approach in Complex Myomectomies
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Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S253
95 Three-Dimensional Versus Two-Dimensional Radical Laparoscopic Hysterectomy for Endometrial and Cervical Cancer: A Prospective Randomized Trial Fanfani F,1 Restaino S,2 Monterossi G,1 Rossitto C,1 Gallotta V,1 Costantini B,1 Cosentino F,1 Gueli Alletti S,1 Scambia G.1 1Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Hearth, Rome, Italy, Division of Gynecologic Oncology, Roma, Italy; 2Institute for Maternal and Child Health - IRCCS ‘‘Burlo Garofolo’’ - University of Trieste, Trieste, Italy Study Objective: To compare operative time between bi-dimensional/ standard laparoscopy (2D) versus three-dimensional laparoscopy (3D) during radical hysterectomy and pelvic lymphadenectomy to treat gynecologic tumors. Design: Randomized, controlled trial (Canadian Task Force classification I). Setting: Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome, Italy. Patients: We enrolled from September 2014 to February 2015, 84 patients of which 24 patients with early cervical cancer (FIGO stages IA2, IB1, IIA,\ 2 cm) or locally advanced cervical cancer (FIGO stages IB2, IIA >2cm, IIB), and 60 patients with early stage endometrial cancer (FIGO stages IB, II). The patients were randomly assigned to standard 2D laparoscopy (Group A) or 3D laparoscopy (Group B). Intervention: Laparoscopic radical hysterectomy with or without bilateral pelvic lymphadenectomy, using a 3D system. Measurements and Main Results: Eighty-four patients were available for analysis, 42 women randomly assigned to Group A and 42 to Group B. In both these groups, 12 (28,6 %) of them had a diagnosis of cervical cancer, while 30 (71.4 %) of them presented an endometrial cancer disease. In Group A the median age was 58 years (38-75) and median BMI was 28 kg/m2 (18-42). In Group B the median age was 58 years (31-75) and median BMI was 27 kg/m2 (19-41). The median operative time was 84 minutes (25-176) for 2D vs 96 minutes for 3D (p=.678). The execution times for the entire procedure and the single tasks were not significantly different between the 2D and 3D groups during radical hysterectomy with or without bilateral pelvic lymphadenectomy. No statistical differences were found in terms of perioperative outcomes and postoperative complications between the 2 arms. Conclusion: Further comparative studies are necessary to address the issue if apprentice surgeons could benefit with 3D vision from reduced learning curve and to verify if 3D imaging could reduce intraoperative and postoperative complications. 96 Feasibility and Safety of a Minimally Invasive Surgical (MIS) Approach in Complex Myomectomies Vargas MV,1 Robinson JK,1 Schwab TD,2 Opoku-Anane J,1 Marfori CQ,1 Moawad GN.1 1Obstetrics and Gynecology Division of Gynecology, George Washington University Medical Center, Washington, District of Columbia; 2Milken Institute School of Public Health, George Washington University, Washington, District of Columbia Study Objective: To assess perioperative outcomes of complex minimally invasive myomectomies. Design: Retrospective chart review (Canadian Task Force Classification II2). Setting: Academic medical center. Patients: Women undergoing minimally invasive myomectomy by three high volume fellowship trained surgeons from April 2011 to December 2014. Intervention: Interventions: Characteristics of patients undergoing laparoscopic and robotic myomectomy with largest myoma size > 10cm
and/or specimen weight > 500g and/or > 10 myomas removed were compared to all other women undergoing myomectomy in the cohort. All surgeons used similar surgical technique. Measurements and Main Results: The cohort included 220 patients. Complex myomectomies accounted for 43% and did not differ in demographics, medical/surgical history, indication for surgery, or surgeon. There was no difference in rate of robotic myomectomy (55% versus 45%, P=0.37) between complex cases and the rest of the cohort. As anticipated, complex cases had a larger specimen weight in grams (mean (SD) 802.6 (461.7) versus 198.9 (124.9), P\.0001), higher number of myomas removed ( median (range) 6 (10-23) versus 2 (1-9), P\.0001), and larger dominant myoma size in cm (mean (SD) 11.2 (3.6) versus 7.1 (2.3), P\.0001). Complex cases also had higher estimated blood loss (EBL) in mL (mean (SD) 595.6 (572.8) versus 197.6 (308.2), P\.0001 and longer operative time in minutes (mean 224 (78.6) versus 158.8 (66.3), P\.0001. There were higher rates of EBL > 1000ccs (22% versus 1%, P\.0001) and transfusion (14% versus 5%, P=0.028) in complex cases. There was no difference in rates of conversion, re-operation, organ injury, ICU admission, venous thromboembolic events, bowel obstruction, and febrile/infectious morbidity. Conclusion: In our cohort, MIS for complex myomectomies was safe and feasible when performed by expert surgeons. The complication rates were comparable, however complex cases had higher rates of hemorrhage/ transfusion. Anticipation of case complexity can guide referral patterns and pre-operative counseling, as well as facilitate the implementation of preventative measures for hemorrhage/transfusion. 97 Postoperative Incisional Bupivacaine in Gynecologic Laparoscopy: A Randomized Controlled Trial Blaber JM, Chappelle JA, Droesch JN, Griffin TR. Department of Obstetrics, Gynecology and Reproductive Medicine, Stony Brook Medicine, Stony Brook, New York Study Objective: To determine if postoperative bupivacaine injection decreases localized pain in the immediate postoperative period at the lateral 10-12mm trocar site. Design: A double blind, randomized, two-arm, parallel-group study comparing saline vs. bupivacaine for localized pain control in gynecologic laparoscopy. Setting: Academic medical center. Patients: Women undergoing elective laparoscopic or robotic procedures were enrolled and followed for 24 hours postoperatively. Forty-two women were needed to detect a 20% decrease in postoperative pain. Of the 79 women recruited, 9 did not meet inclusion criteria, and 27 women did not complete the postoperative questionnaires. The data from 20 women who received bupivacaine and 23 women who received saline was analyzed. Intervention: 10ml of normal saline or 0.25% bupivacaine was used to infiltrate all tissue layers of the 10-12 lateral trocar site after fascial closure. Localized postoperative pain was evaluated for 24 hours using a visual analog scale and narcotic use was recorded. Measurements and Main Results: The demographic characteristics of the two groups did not differ significantly. No statistical difference between the two groups was found for local postoperative pain at the study port site by VAS scores at 4-6 hours postoperatively (3.80 +/- 2.70 vs 4.80 +/- 2.73, p = 0.2578) or 24 hours postoperatively (4.80 +/- 1.98 vs 4.55 +/- 2.62, p = 0.6912). Narcotic use did not vary between the bupivacaine and the saline groups (37.73mg in the bupivacaine group vs 31.20mg in the saline group, p= 0.5214). Women who received bupivacaine were more likely to report increased overall pain 4-6 hours postoperatively (3.60+/- 1.60 vs 5.20 +/- 2.61, p = 0.0173). Conclusion: Postoperative infiltration of bupivacaine is not effective in decreasing local postoperative pain. Women who received bupivacaine reported greater overall pain 4-6 hours postoperatively but did not use
Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S253
95 Three-Dimensional Versus Two-Dimensional Radical Laparoscopic Hysterectomy for Endometrial and Cervical Cancer: A Prospective Randomized Trial Fanfani F,1 Restaino S,2 Monterossi G,1 Rossitto C,1 Gallotta V,1 Costantini B,1 Cosentino F,1 Gueli Alletti S,1 Scambia G.1 1Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Hearth, Rome, Italy, Division of Gynecologic Oncology, Roma, Italy; 2Institute for Maternal and Child Health - IRCCS ‘‘Burlo Garofolo’’ - University of Trieste, Trieste, Italy Study Objective: To compare operative time between bi-dimensional/ standard laparoscopy (2D) versus three-dimensional laparoscopy (3D) during radical hysterectomy and pelvic lymphadenectomy to treat gynecologic tumors. Design: Randomized, controlled trial (Canadian Task Force classification I). Setting: Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome, Italy. Patients: We enrolled from September 2014 to February 2015, 84 patients of which 24 patients with early cervical cancer (FIGO stages IA2, IB1, IIA,\ 2 cm) or locally advanced cervical cancer (FIGO stages IB2, IIA >2cm, IIB), and 60 patients with early stage endometrial cancer (FIGO stages IB, II). The patients were randomly assigned to standard 2D laparoscopy (Group A) or 3D laparoscopy (Group B). Intervention: Laparoscopic radical hysterectomy with or without bilateral pelvic lymphadenectomy, using a 3D system. Measurements and Main Results: Eighty-four patients were available for analysis, 42 women randomly assigned to Group A and 42 to Group B. In both these groups, 12 (28,6 %) of them had a diagnosis of cervical cancer, while 30 (71.4 %) of them presented an endometrial cancer disease. In Group A the median age was 58 years (38-75) and median BMI was 28 kg/m2 (18-42). In Group B the median age was 58 years (31-75) and median BMI was 27 kg/m2 (19-41). The median operative time was 84 minutes (25-176) for 2D vs 96 minutes for 3D (p=.678). The execution times for the entire procedure and the single tasks were not significantly different between the 2D and 3D groups during radical hysterectomy with or without bilateral pelvic lymphadenectomy. No statistical differences were found in terms of perioperative outcomes and postoperative complications between the 2 arms. Conclusion: Further comparative studies are necessary to address the issue if apprentice surgeons could benefit with 3D vision from reduced learning curve and to verify if 3D imaging could reduce intraoperative and postoperative complications. 96 Feasibility and Safety of a Minimally Invasive Surgical (MIS) Approach in Complex Myomectomies Vargas MV,1 Robinson JK,1 Schwab TD,2 Opoku-Anane J,1 Marfori CQ,1 Moawad GN.1 1Obstetrics and Gynecology Division of Gynecology, George Washington University Medical Center, Washington, District of Columbia; 2Milken Institute School of Public Health, George Washington University, Washington, District of Columbia Study Objective: To assess perioperative outcomes of complex minimally invasive myomectomies. Design: Retrospective chart review (Canadian Task Force Classification II2). Setting: Academic medical center. Patients: Women undergoing minimally invasive myomectomy by three high volume fellowship trained surgeons from April 2011 to December 2014. Intervention: Interventions: Characteristics of patients undergoing laparoscopic and robotic myomectomy with largest myoma size > 10cm
and/or specimen weight > 500g and/or > 10 myomas removed were compared to all other women undergoing myomectomy in the cohort. All surgeons used similar surgical technique. Measurements and Main Results: The cohort included 220 patients. Complex myomectomies accounted for 43% and did not differ in demographics, medical/surgical history, indication for surgery, or surgeon. There was no difference in rate of robotic myomectomy (55% versus 45%, P=0.37) between complex cases and the rest of the cohort. As anticipated, complex cases had a larger specimen weight in grams (mean (SD) 802.6 (461.7) versus 198.9 (124.9), P\.0001), higher number of myomas removed ( median (range) 6 (10-23) versus 2 (1-9), P\.0001), and larger dominant myoma size in cm (mean (SD) 11.2 (3.6) versus 7.1 (2.3), P\.0001). Complex cases also had higher estimated blood loss (EBL) in mL (mean (SD) 595.6 (572.8) versus 197.6 (308.2), P\.0001 and longer operative time in minutes (mean 224 (78.6) versus 158.8 (66.3), P\.0001. There were higher rates of EBL > 1000ccs (22% versus 1%, P\.0001) and transfusion (14% versus 5%, P=0.028) in complex cases. There was no difference in rates of conversion, re-operation, organ injury, ICU admission, venous thromboembolic events, bowel obstruction, and febrile/infectious morbidity. Conclusion: In our cohort, MIS for complex myomectomies was safe and feasible when performed by expert surgeons. The complication rates were comparable, however complex cases had higher rates of hemorrhage/ transfusion. Anticipation of case complexity can guide referral patterns and pre-operative counseling, as well as facilitate the implementation of preventative measures for hemorrhage/transfusion. 97 Postoperative Incisional Bupivacaine in Gynecologic Laparoscopy: A Randomized Controlled Trial Blaber JM, Chappelle JA, Droesch JN, Griffin TR. Department of Obstetrics, Gynecology and Reproductive Medicine, Stony Brook Medicine, Stony Brook, New York Study Objective: To determine if postoperative bupivacaine injection decreases localized pain in the immediate postoperative period at the lateral 10-12mm trocar site. Design: A double blind, randomized, two-arm, parallel-group study comparing saline vs. bupivacaine for localized pain control in gynecologic laparoscopy. Setting: Academic medical center. Patients: Women undergoing elective laparoscopic or robotic procedures were enrolled and followed for 24 hours postoperatively. Forty-two women were needed to detect a 20% decrease in postoperative pain. Of the 79 women recruited, 9 did not meet inclusion criteria, and 27 women did not complete the postoperative questionnaires. The data from 20 women who received bupivacaine and 23 women who received saline was analyzed. Intervention: 10ml of normal saline or 0.25% bupivacaine was used to infiltrate all tissue layers of the 10-12 lateral trocar site after fascial closure. Localized postoperative pain was evaluated for 24 hours using a visual analog scale and narcotic use was recorded. Measurements and Main Results: The demographic characteristics of the two groups did not differ significantly. No statistical difference between the two groups was found for local postoperative pain at the study port site by VAS scores at 4-6 hours postoperatively (3.80 +/- 2.70 vs 4.80 +/- 2.73, p = 0.2578) or 24 hours postoperatively (4.80 +/- 1.98 vs 4.55 +/- 2.62, p = 0.6912). Narcotic use did not vary between the bupivacaine and the saline groups (37.73mg in the bupivacaine group vs 31.20mg in the saline group, p= 0.5214). Women who received bupivacaine were more likely to report increased overall pain 4-6 hours postoperatively (3.60+/- 1.60 vs 5.20 +/- 2.61, p = 0.0173). Conclusion: Postoperative infiltration of bupivacaine is not effective in decreasing local postoperative pain. Women who received bupivacaine reported greater overall pain 4-6 hours postoperatively but did not use