{"paper_id":"33aec3d9-333c-4073-845a-22e20b009db1","body_text":"Safety Model for the Introduction of Robotic\nSurgery in Gynecology\nModelo de segurança para a introdução da cirurgia\nrobótica em ginecologia\nMariano Tamura Vieira Gomes 1 Beatriz Taliberti da Costa Porto 1 Jose Pedro Parise Filho 1\nAna Luiz Vasconcelos 1 Bruna Fernanda Bottura 1 Renato Moretti Marques 1\n1 Hospital Israelita Albert Einstein, São Paulo, SP, Brazil\nRev Bras Ginecol Obstet 2018;40:397 –402.\nAddress for correspondence Mariano Tamura Vieira Gomes, Hospital\nIsraelita Albert Einstein, Av. Albert Einstein, 627, 05652-900, Bloco\nA1, 5° andar, sala 508, Morumbi. São Paulo, SP, Brazil\n(e-mail: biacostaporto@yahoo.com.br; marianotamura@hotmail.com).\nKeywords\n► robotics\n► robotic surgical\nprocedures/adverse\neffects\n► gynecologic surgical\nprocedures/methods\n► endometriosis/\nsurgery\n► gynecology\nAbstract Objective To analyze the perioperative results and safety of performing gynecologi-\ncal surgeries using robot-assisted laparoscopy during implementation of the technique\nin a community hospital over a 6-year period.\nMethods This was a retrospective observational study in which the medical records of\n274 patients who underwent robotic surge ry from September 2008 to December 2014\nwere analyzed. We evaluated age, body mass index (BMI), diagnosis, procedures\nperformed, American Society of Anesthesiologists (ASA) classi fication, the presence of\na proctor (experienced surgeon with at least 20 robotic cases), operative time,\ntransfusion rate, perioperative complicatio ns, conversion rate, length of stay, referral\nto the intensive care unit (ICU), and mortality. We compared transfusion rate,\nperioperative complications and convers ion rate between procedures performed by\nexperienced and beginner robotic surgeo ns assisted by an experienced proctor.\nResults During the observed period, 3 experienced robotic surgeons performed 187\nsurgeries, while 87 surgeries were performed by 20 less experienced teams, always with the\nassistance of a proctor. The median patient age was 38 years, and the median BMI was\n23.3 kg/m\n2. The most frequent diagnosis was endometriosis (57%) and the great majority\nof the patients were classi fied as ASA I or ASA II (99.6%). The median operative time was\n225 minutes, and the median length of stay was 2 days. We observed a 5.8% transfusion\nrate, 0.8% rate of perioperative complications, 1.1% conversion rate to laparoscopy or\nlaparotomy, no patients referred to ICU, and no deaths. There were no differences in\ntransfusion, complications and conversion rates between experienced robotic surgeons\nand beginner robotic surgeons assisted by an experienced proctor.\nConclusion In our casuistic, robot-assisted laparoscopy demonstrated to be a safe\ntechnique for gynecological surgeries, and the presence of an experienced proctor was\nconsidered a highlight in the safety model adopted for the introduction of the robotic\ngynecological surgery in a high-volume hospital and, mainly, for its extension among\nseveral surgical teams, assuring patient safety.\nreceived\nOctober 30, 2017\naccepted\nApril 9, 2018\npublished online\nMay 18, 2018\nDOI https://doi.org/\n10.1055/s-0038-1655746.\nISSN 0100-7203.\nCopyright © 2018 by Thieme Revinter\nPublicações Ltda, Rio de Janeiro, Brazil\nTHIEME\nOriginal Article 397\n\n\nIntroduction\nIn the 1990s, laparoscopy, previously relegated to diagnostic\nprocedures, gained prominence in surgeries on the female\nreproductive system. 1 The evolution from open surgery to\nlaparoscopy brought bene fits for patients, and robotics rep-\nresents a technological advancement in minimally invasive\nsurgery.1 The word robot refers to compulsory or mandatory\nwork, and the term was created and first used by Karel Capek\nin 1920, in his play Rossum Universal Robots . The Robotics\nInstitute of America de fines a robot as a machine that has a\nhuman form of performing tasks, possibly with more precise\nskills.2\nRobotic surgery models emerged in the 1980s at the\nrequest of the United States Army, which sought alternatives\nfor the surgical treatment of soldiers wounded on the\nbattlefield.3 Robotic systems were continually created until\nthe development of the da Vinci System (Intuitive Surgical,\nSunnyvale, California, USA), which is now widely used for\nprocedures in different specialties, including gynecology. 4 In\nBrazil, the Hospital Israelita Albert Einstein (HIAE) has\npioneered the practice of robot-assisted laparoscopy in\nseveral specialties, including gynecology, and has performed\na growing number of procedures since 2008.\nStudies have compared the perioperative results of conven-\ntional, laparoscopic, and robotic surgeries in the field of\ngynecology, including benign and malignant surgeries, mainly\nhysterectomies.\n5,6 The disadvantages of conventional surgery\nover laparoscopy are clear in terms of abdominal incisions,\nlength of stay, greater need for postoperative analgesia, and\nhigher complication rates.5–7 On the other hand, when robot-\nassisted laparoscopy is compared with conventional laparos-\ncopy, it would be expected that complex procedures become\nsafer and more reproducible, as certain dif ficulties would be\novercome. These include limitations on instruments range of\nmotion, two-dimensional vision, tremor, ability to perform\nlaparoscopic sutures, the need for an assistant to hold the\ncamera, and a steep learning curve in the laparoscopy.\n4,7\nRobot-assisted laparoscopy can be used in many gyneco-\nlogical procedures, including myomectomies, hysterectomies,\nPalavras-chave\n► robótica\n► procedimentos\ncirúrgicos robóticos/\nefeitos adversos\n► procedimentos\ncirúrgicos em\nginecologia/métodos\n► endometriose/\ncirurgia\n► ginecologia\nResumo Objetivo Analisar os resultados perioperatórios e a segurança da realização de\ncirurgias ginecológicas por laparoscopia robô-assistida durante a implementação da\ntécnica num hospital comunitário ao longo de 6 anos.\nMétodos Este foi um estudo retrospectivo observacional, com análise dos prontuários de\n274 pacientes que se submeteram à cirurgia robótica de setembro de 2008 a dezembro de\n2014. Avaliamos idade, índice de massa corpórea (IMC), diagnóstico, procedimentos\nrealizados, classificação da Sociedade Americana de Anestesiologia (ASA), presença de um\npreceptor (cirurgião experiente, com pelo menos 20 casos robóticos), tempo cirúrgico, taxa\nde transfusão, complicações perioperatórias, taxa de conversão, tempo de internação,\nencaminhamento para Unidade de Terapia Intensiva (UTI) e mortalidade. Comparamos\ntaxa de transfusão, complicações perioperatórias e taxa de conversão entre procedimentos\nrealizados por cirurgiões experientes com a técnica e cirurgiões iniciantes na robótica,\nsempre assistidos por um preceptor experiente.\nResultados Durante o período observado, 3 cirurgiões experientes realizaram 187\ncirurgias, enquanto que 87 cirurgias foram realizadas por 20 equipes menos expe-\nrientes, sempre com a presença de um prec eptor. A mediana da idade foi 38 anos, e a\nmediana do IMC foi 23,3 kg/m\n2. O diagnóstico mais frequente foi endometriose (57%) e\na grande maioria das pacientes foi classi ficada como ASA I ou ASA II (99,6%). O tempo\nde cirurgia teve uma mediana de 225 minutos, e o tempo de permanência hospitalar\nteve uma mediana de 2 dias. Observamos 5,8% de taxa de transfusão, 0,8% de taxa de\ncomplicações perioperatórias, 1,1% de taxa de conversão para laparoscopia ou\nlaparotomia e não houve pacientes encaminhadas à UTI, nem óbitos. Não houve\ndiferença nos índices de transfusão, complicações e conversão entre cirurgiões\nexperientes e cirurgiões iniciantes na robóti ca, assistidos por um preceptor experiente.\nConclusão Em nossa casuística, a laparoscopia robô-assistida demonstrou ser uma\ntécnica segura para cirurgias ginecológicas, e a presença de um preceptor experiente\nfoi considerada um ponto de destaque no modelo de segurança adotado para a\nintrodução da cirurgia robótica em ginecologia num hospital de grande volume e,\nprincipalmente, na sua expa nsão entre diversas equipes cirúrgicas, mantendo a\nsegurança das pacientes.\nRev Bras Ginecol Obstet Vol. 40 No. 7/2018\nSafety Model for the Introduction Gomes et al.398\n\n\nadnexal surgeries, treatment of endometriosis, sacrocolpopex-\nies, tubal reanastomosis, and oncological surgeries, including\npelvic and para-aortic lymphadenectomies.\n8–13 However,\ntechnological implementation in a surgical environment, es-\npecially when it involves several or many teams, with different\nlevels of training and skills, is a great challenge and responsi-\nbility because patient safety can never be put at risk, otherwise\nthe use of those tools should be strongly discouraged. Proctors\nin our hospital are designated by a multidisciplinary surgical\ncommittee. They need to be experienced in laparoscopy and\nrecognized as pro ficient in robotics, with a minimum of 20\nrobotics cases (usually more than that). Those proctors have\nthe function of supporting other less experienced teams\nthroughout the surgery and handling the robot, with the\nrole of intervening and even performing some steps of the\nprocedure, if necessary. At the end, they evaluate the surgeons’\nskills in the different tasks of operations. It is also the proctor\nwho formally enables other surgeons to perform procedures\non their own after proven pro ficiency, thus ensuring good\nsurgical results while always prioritizing patient safety.\nThe objective of this study was to analyze the periopera-\ntive results and safety of performing gynecological surgeries\nusing robot-assisted laparoscopy during implementation of\nthe technique over a 6-year period, considering procedures\nperformed with and without a proctor.\nMethods\nThis retrospective, observational and cross-sectional study\nwas approved by the Institutional Medical Ethics Committee,\nCAAE: 38045414.7.0000.0071. We analyzed the medical\nrecords of 274 patients who underwent gynecological sur-\ngeries for benign or malignant diseases at the Hospital\nIsraelita Albert Einstein (HIAE), São Paulo, Brazil, from Sep-\ntember 2008 to December 2014. Patients with surgical\nindication for the treatment of gynecological diseases were\nincluded, and patients with non-gynecological procedures\nwere excluded, even if there was a gynecological procedure\nfor them as well.\nThe study considered each patient age, BMI, ASA classifica-\ntion, and diagnosis. We evaluated the procedures performed,\noperative time, length of stay, perioperative complications,\nblood transfusion, conversions (laparoscopy or laparotomy),\ntransfer to the intensive care unit, and mortality. The data were\ndescriptively analyzed using absolute frequency and percen-\ntages for qualitative variables and averages, standard devia-\ntions, or medians and quartiles for quantitative variables. The\nmedian was selected in cases of asymmetric sample distribu-\ntion. The analyses were performed using SPSS statistical\nprogram, version 17.0 (SPSS Inc., Chicago, USA) to compare\ncomplications, transfusion rate and surgical conversion be-\ntween experienced robotic surgeons without proctor and\nbeginner robotic surgeons with proctor assistance.\nResults\nThe number of surgeries was found to have increased over\nthe course of the study period, with 16 (5.8%) surgeries in\n2009, 22 (8.0%) in 2010, 45 (16.4%) in 2011, 38 (13.9%) in\n2012, 63 (23%) in 2013, and 87 (31.8%) in 2014. In 2008, three\n(1.1%) surgeries were performed from September to Decem-\nber. Three teams performed the procedures in 187 patients\n(68.2%), with a mean of 62.33 cases per surgeon (range: 27 –\n126). Twenty teams still in their initial robotics learning\ncurve were responsible for 87 cases (31.8%), with a mean of\n4.35 cases per surgeon (range: 1 –14), always with the\nparticipation of a proctor.\nThe patients were aged 20 to 84 years, with a median age\nof 38 years, and the BMI range was 16 to 46.7 kg/m\n2,w i t ha\nmedian of 23.3 kg/m 2. In the surgical risk evaluation, only\none patient had a preoperative ASA score of III (0.4%). The\nothers were classi fied as ASA I or ASA II, indicating low\nclinical-surgical risk. The following preoperative diagnoses\nwere found: endometriosis, uterine myoma, endometrial\ncancer, adenomyosis, and benign ovarian tumor. The follow-\ning procedures were performed: ovarian cystectomy, treat-\nment of intestinal endometriosis, hysterectomy, treatment\nof deep endometriosis (other than intestinal), myomectomy,\noophorectomy, lymphadenectomy and sacrocolpopexy. The\nmost frequent diagnosis was endometriosis, which occurred\nin 192 patients (70.1%). The most frequent procedures were\novarian cystectomy (22%) and treatment of intestinal endo-\nmetriosis (20%) (\n►Tables 1 and 2).\nThe diagnoses were included in the study as individual\noccurrences, given that each patient might have more than\none diagnosis at the time of surgical decision. The same was\nconsidered for the procedures performed, as different pro-\ncedures could be necessary during a single patient surgery.\nThe operative time was 55 to 600 minutes, with a median\nTable 1 Distribution of surgeries by the preoperative diagnosis\n(n ¼ 338)\nDiagnosis n (%)\nEndometriosis 193 (57)\nUterine myoma 120 (35.5)\nEndometrial cancer 10 (3)\nAdenomyosis 10 (3)\nBenign ovarian tumor 5 (1.5)\nTable 2 Distribution of procedures performed ( n ¼ 501)\nProcedures n (%)\nOvarian cystectomy 110 (22)\nTreatment of intestinal endometriosis 101 (20)\nHysterectomy 89 (17.8)\nTreatment of deep endometriosis\n(other than intestinal)\n85 (17)\nMyomectomy 66 (13.2)\nOophorectomy 40 (8)\nLymphadenectomy 9 (1.8)\nSacrocolpopexy 1 (0.2)\nRev Bras Ginecol Obstet Vol. 40 No. 7/2018\nSafety Model for the Introduction Gomes et al. 399\n\n\ntime of 225 minutes (interquartile range [IQR]: 150–280 min-\nute). The postoperative length of stay was 0.5 to 12 days, with\na median time of 2 days (IQR: 2 –3 days). Transfusions were\nrequired in 5.8% of the surgeries (1 –3 red blood cell concen-\ntrates). There were complications in 2.6% of the surgeries and\nconversion to laparotomy or laparoscopy in 1.1% of the cases.\nThere were no transfers to the ICU and no deaths (\n►Table 3 ).\nThere were no differences in complication rates between the\ngroup of surgeons with less experience in robotics (who were\nalways assisted by a proctor) and the group of more experi-\nenced surgeons (\n►Table 4 ).\nDiscussion\nA 2010 review showed that robotic surgery has gradually\nbecome a frequent choice, and this modality has demon-\nstrated good results in terms of reducing trauma and short-\nening the length of stay, with fewer complications, as\nevidenced by the extent to which it has been more present\nin several specialties every day.\n14 Although most gynecolog-\nical procedures could be done by robotics, and this technol-\nogy has been recently made available in more than 30\nhospitals in Brazil, the number of procedures is still low\neven in those hospitals, demonstrating the dif ficulty in\nqualifying a good number of surgeons to use this technology\nsafely and effectively.\nIn this study, we focused on safety-related outcomes,\nevaluating two distinct groups of surgeons: 20 with little\nexperience in robotics (mean: 4.35 cases per surgeon; range:\n1–14) and 3 experienced robotic surgeons (mean: 62.33\ncases per surgeon; range: 27–126). The results demonstrated\nlow rates of complications, transfusion and conversion, even\nwhen surgeons less experienced in robotics did the proce-\ndures, always assisted by an experienced proctor. However,\nwe emphasize that our results have limitations related to\nstudy design, because it is retrospective and observational,\nwith convenience sample, since we could not perform sam-\nple size analysis and may not have adequately identi fied\nconfounding factors.\nIn a 2009 retrospective study that compared robotic\nsurgery to laparoscopy for hysterectomy, the operative\ntime was found to be like those reported in our casuistic.\nThere were no statistically signi ficant differences in opera-\ntive time, blood loss or length of stay, and conversion to\nlaparoscopy was not required.\n15 Reynolds and Advincula 16\nand Hanssens et al 17 have shown that the time required for\nrobotic surgery exceeds that for laparoscopy, though these\nresults vary according to the surgeons ’ experience.\nFastrez et al, 18 in a multicenter study with a group of 37\nrobot-assisted pelvic lymphadenectomies, reported that one\npatient had an aortic injury requiring conversion to laparotomy\nTable 3 Distribution of surgeries by parameters analyzed in the\ncase series ( n ¼ 274)\nDistribution of surgeries\nOperative time Minutes\nMedian (IQR) 225 (150 –280)\nMinimum –Maximum 55 –600\nPostoperative length of stay Days\nMedian (IQR) 2(2 –3)\nMinimum –Maximum 0.5 –12\nNeed for transfusion n (%)\nNo 258 (94.2)\nYes 16 (5.8)\nAmount transfused n (%)\nNone 258 (94.2)\n17 ( 2 . 6 )\n27 ( 2 . 6 )\n32 ( 0 . 7 )\nDescription of perioperative\ncomplications\nn( % )\nNo complications 272 (99.2)\nUreteral reconstruction due to\nureteral injury\n1( 0 . 4 )\nColonic fistula, with colostomy\nperformed\n1( 0 . 4 )\nSurgical conversion\n(laparoscopy/laparotomy)\nn( % )\nNo conversion 271 (98.9)\nLaparoscopy 2 (0.7)\nLaparotomy 1 (0.4)\nIntra-hospital mortality/Transfer\nto ICU\nn( % )\nNone 0 (0)\nAbbreviation: IQR, interquartile range.\nTable 4 Comparison of complication, conversion and\ntransfusion rates between surgeries performed with and\nwithout proctor ( n ¼ 274)\nVariables Without proctor With proctor\nNeed for transfusion n (%)\nNo 177 (94.7) 81 (93.1)\nYes 10 (5.3) 6 (6.9)\np\n1 ¼ 0.611\nComplications n (%)\nNo 186 (99.5) 86 (98.9)\nYes 1 (0.5)\ncolonic fistula requir-\ning colostomy\n1 (1.1)\nureter injury requir-\ning reconstruction\np2 ¼ 0.535\nSurgical conversion n (%) (laparoscopy/laparotomy)\nNo 185 (98.9) 86 (98.9)\nYes 2 (1.1)\nlaparoscopy\n1 (1.1)\nlaparotomy\np\n2 > 0.999\np1,c h i - s q u a r e dt e s t ;p2,F i s h e re x a c tt e s t .\nRev Bras Ginecol Obstet Vol. 40 No. 7/2018\nSafety Model for the Introduction Gomes et al.400\n\n\nand one patient had a ureteral lesion treated without conver-\nsion. In the nine lymphadenectomies performed at HIAE, none\nof these complications were observed, a result which re flects\nthe safety of this kind of approach for this procedure.\nAt the hospital evaluated herein, 66 myomectomies were\nperformed through minimally invasive robot-assisted ap-\nproach between 2008 and 2014 and no conversions were\nrequired. This result is compatible with the data from Cheng\net al,\n19 in which 21 robotic myomectomies were performed\nbetween 2010 and 2012 with no conversions were required\neither.\nIn 2015, Corrado et al 20 compared different surgical\napproaches for the treatment of endometrial cancer and\nshowed that the group who underwent robotic surgery\nhad a 1.4% rate of conversion to laparotomy and a 2.7% rate\nof conversion to laparoscopy, comparable to the rate ob-\nserved at HIAE for all robotic gynecological surgeries be-\ntween 2008 and 2014 (1.1%). The same authors reported a\n1.4% blood transfusion rate, slightly lower than the 5.8%\nobserved in the current study.\n20\nAlthough we had only one case of sacrocolpopexy, a\nsystematic review conducted in 2016 by Pan et al, 21 showed\nthat the robotic approach is as safe as laparoscopy for\nperforming the procedure, as there are no statistical differ-\nences between the two approaches in either complication\nrates or operative time. One of the biggest challenges of\nminimally invasive gynecological surgery is the dif ficulty in\nperforming this type of approach on morbidly obese\npatients.\n22 Being aware of this issue, minimally invasive\nsurgeries must be introduced slowly and safely to those\npatients. Our casuistic had three patients with\nBMI > 40 kg/m 2, with no complications at all.\nConclusion\nRobot-assisted laparoscopy in gynecological surgeries has\nbeen shown to be safe, with the presence of a proctor being\ncritical for a successful transition for less experienced teams.\nThis study demonstrates the safety of the model here pre-\nsented for the introduction of robotic gynecological surgery\ninto the hospital practice, but the rapid development in\nrobot-assisted surgery calls for long-term prospective ran-\ndomized controlled trials.\nConflicts of Interest\nThe authors have no con flicts of interest to disclose.\nContributors\nGomes M. T. V., Costa B. T., Parise Filho J. P., Vasconcelos A.\nL., Bottura B. F. and Marques R. M. contributed with project\nand interpretation of data, writing of the article, critical\nreview of the intellectual content and final approval of the\nversion to be published.\nAcknowledgments\nThe authors would like to thank for Edna Roter, Fernanda\nAssir and Elivane da Silva Victor for their technical\nassistance.\nReferences\n1 García OF, Olvera HR, Montoya JJ. [Telemedicine and robotic\nsurgery in gynecology]. Ginecol Obst Mex 2008;76:161 –166\n2 Rafiq A, Merrell RC. Telemedicine for access to quality care on\nmedical practice and continuing medical education in a global\narena. J Contin Educ Health Prof 2005;25(01):34 –42. Doi:\n10.1002/chp.7\n3 Satava RM. Looking forward. Surg Endosc 2006;20(Suppl 2):\nS503–S504. Doi: 10.1007/s00464-006-0057-9\n4 Senapati S, Advincula AP. Telemedicine and robotics: paving the\nway to the globalization of surgery. Int J Gynaecol Obstet 2005;91\n(03):210–216. Doi: 10.1016/j.ijgo.2005.08.016\n5 Fanfani F, Restaino S, Ercoli A, et al. 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