Robotic-Assisted Surgery for the Community Gynecologist: Can it Be Adopted?
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CLINICAL OBSTETRICS AND GYNECOLOGY Volume 54, Number 3, 391–411 r 2011, Lippincott Williams & Wilkins Robotic-Assisted Surgery for the Community Gynecologist: Can it Be Adopted? THOMAS N. PAYNE, MD* and MICHAEL C. PITTER, MDw *Texas Institute for Robotic Surgery, Austin, Texas; and w Department of Obstetrics and Gynecology, Newark Beth Israel Medical Center, Newark, New Jersey Abstract: The American College of Obstetricians and Gynecologists and the American Association of Gyneco- Introduction logic Laparoscopists confirm advantages of conventional Minimally invasive surgery (MIS) is minimally invasive surgery over laparotomy for benign superior to traditional open surgery when gynecological procedures; however, adoption remains achievable.1 However, historically adop- low for the general gynecologist. A systematic search for tion of vaginal and conventional laparo- gynecology publications was performed using Medline and Scopus. Available data on adoption rates and peri- scopy by the general obstetrician/ operative outcomes for hysterectomy, myomectomy, sa- gynecologist has been anemic at best. In crocolpopexy, and endometriosis were reviewed. Robotic fact, failure to adopt MIS techniques has assistance may provide an improved rate of minimally led to a recent strong statement by the invasive surgery adoption with equivalent perioperative American Association of Gynecologic outcomes to that of conventional techniques. Accessibility and cost remain controversial. Formal training programs Laparoscopists: ‘‘Surgeons without the are being created to address these issues. requisite training and skills required for Key words: hysterectomy, myomectomy, sacrocolpo- the safe performance of vaginal hysterec- pexy, endometriosis, robotic assistance, community tomy (VH) or laparoscopic hysterectomy gynecologist (LH) should enlist the aid of colleagues who do or should refer patients requiring hysterectomy to such individuals for their surgical care.’’2 Vaginal and laparoscopic Correspondence: Thomas N. Payne, MD, Texas Insti- approaches have been available for many tute for Robotic Surgery, 12221 Renfert, Austin, TX 78758. E-mail: tnpayne@hotmail.com years and a multitude of excellent re- The authors have the following conflicts of interest to search demonstrates their superiority declare. Drs Payne and Pitter serve as proctors and over laparotomy with regard to surgical on the speaker’s bureau for Intuitive Surgical Inc (Sunnyvale, CA). outcomes, patient safety, and recovery.1 CLINICAL OBSTETRICS AND GYNECOLOGY / VOLUME 54 / NUMBER 3 / SEPTEMBER 2011 www.clinicalobgyn.com | 391
392 Payne and Pitter Centers of excellence with highly trained Methods surgeons report high rates of MIS We performed a systematic search for using traditional techniques with few studies comparing robotic versus laparo- contraindications.2 scopic, vaginal, or abdominal approaches Unfortunately, these results are rarely for benign gynecologic procedures using duplicated by the general gynecologist, the MEDLINE database and Scopus who performs the vast majority of benign search engine. The search term ‘‘robot* ’’ procedures in the United States each year was used with each of the following key- (B700,000/y) (Solucient. Quarterly Re- words: benign hysterectomy, myomect- port. Thomson Reuters 2006). Unique omy, sacrocolpopexy, sacral colpopexy, challenges for the community surgeon in and endometriosis. mastering MIS include: inconsistent train- Full text original articles published in ing across generations and programs, de- English were included. Case studies were pendency on various nonstandardized excluded. There was no time period speci- review courses to initiate learning, and fied and the last search was performed ‘‘on the job’’ training to attain competency. in February 2011. Both comparison and In addition, all this needs to be achieved single-cohort studies were included as long under the daily temporal and financial as they reported on a robotic cohort. For pressures of the community practice envir- each study, surgical approach, periopera- onment. Consequently, the majority of tive outcomes [operative time, estimated gynecologists turn to the easiest, most fa- blood loss (EBL), length of hospital stay, miliar, and efficient procedure known to complications, conversions, pain levels, them: abdominal surgery. Unfortunately, narcotic use], and cost data were ab- it is the patient who suffers the incision, stracted. Procedure-specific parameters increased risk of adhesions, increased abstracted included incidence of earlier blood transfusions, increased infection abdominal surgery and uterine weight for rates, and longer recovery times.1 benign hysterectomy, myoma weight, size, Robotic-assisted surgery was approved type, and number of myoma removed for by the Food and Drug Administration for myomectomy, pelvic organ prolapse ques- gynecologic procedures in 2005. The main tionnaire (POP-Q) ‘‘C’’ scores, concurrent advantage is the ability to duplicate open procedures, mesh erosion and recurrence surgical techniques by laparoscopic ac- rates for sacrocolpopexy, and stage of dis- cess. This is made possible by using the ease for endometriosis. The perioperative da Vinci Surgical System with its articu- complication rate abstracted included blood lating EndoWrist (Intuitive Surgical, transfusions but not conversions or the Sunnyvale, CA) instruments (motion complications resulting in conversions, scaling, tremor control, and 7 degrees of and represented the percentage of patients freedom) and the 3-dimensional high de- experiencing at least 1 complication. finition vision system. There is a rapidly growing body of research with regard to gynecologic robotic surgery (Fig. 1); STATISTICAL ANALYSIS however, questions remain regarding out- Meta-analyses of the data were performed comes, adoption, cost, and training. It when there were at least 2 comparison is the authors’ desire to use the body of studies for a procedure (hysterectomy, work to date to help address these legit- myomectomy, sacrocolpopexy, or endo- imate questions specifically for the com- metriosis) with at least 25 cases per surgical munity gynecologist. In addition, we approach. Statistical analysis was per- will examine how successful community formed with SAS System version 9.2 robotic programs are constructed. (SAS Institute, Inc., Cary, NC). Odds www.clinicalobgyn.com
Robotic Surgery for the General Gynecologists 393 FIGURE 1. Robotic Benign Gynecology Publications. This graph shows the number of publica- tions reporting on robotic-assisted laparoscopic hysterectomy (gray boxes), robotic myomectomy (stripped boxes), robotic sacrocolpopexy (white boxes), or other robotic gynecological surgery (black boxes) by year. If a study reported on multiple categories, it was counted more than once. ratios and confidence intervals were calcu- majority of comparison studies were retro- lated using the Mantel-Haenszel method spective and uzed a historical con- for discrete variables (complication and trol.4,5,8,11,14,17 There was 1 study that was conversion rates), and mean differences prospective7 and a few that were matched were calculated for continuous variables controlled investigations.6,7,10,12,17 Single- (operative time, uterine weight, myoma cohort robotic hysterectomy studies ranged weight, blood loss, and length of hospital from feasibility studies with a small sample stay). When only medians were reported, size,20–23 to larger scale studies demonstrat- they were used as estimates of means. ing optimization of operative time,24,25 im- Confidence intervals for the mean differ- provement of perioperative outcomes,26 ences were calculated using the standard and successful completion of robotic-as- deviation. When standard deviations were sisted hysterectomy for complex cases.27–29 not provided and there were 70 or fewer For myomectomy, single-cohort robotic patients, the standard deviation was esti- studies focused on initial experience,30 the mated as the total range divided by 4.3 impact of obesity on outcomes,31 and the Studies were weighted based on the number successful removal of deep intramural myo- of patients and results considered signifi- mas (a location unfavorable for conven- cant when P
394 Payne and Pitter robotic and vaginal approaches, we will assisted LH (RALH) when compared touch only briefly on these results and will with LH, which includes laparoscopic- focus on the results of robotic comparison assisted vaginal hysterectomy (LAVH), studies including conventional laparo- total laparoscopic hysterectomy, and la- scopic and abdominal hysterectomy and paroscopic supracervical hysterectomy as myomectomy procedures. noted. This was achieved with all authors reporting more complex pathology as evi- denced by higher average uterine weights HYSTERECTOMY in their robotic cohorts. This was sup- A recent survey by Einarsson et al45 de- ported by success in 2 single-cohort ro- monstrates that the overwhelming major- botic studies (Table 1) with high uterine ity of gynecologists favor MIS techniques weights 29 and complex pathology.28 Both (with its proven benefits) for their own authors reported low conversion (1.6% family members and admitted that there and 0%) and complication rates (3.5% exists a number of barriers to achieving and 5.3%), respectively. this goal for their patients. Despite dec- In fact, conversion rates seem to be a ades of experience with conventional LH strong suit for robotic assistance, with the and over a century of experience with VH, majority of authors reporting a very low exploratory laparotomy remains the incidence of exploratory laparotomy. All route of choice in more than 60% of the comparison studies reported open rates of 600,000 hysterectomy procedures per- 4% or less in their studies using robotic formed annually.46 Thus, the question assistance4–9 (Fig. 2). becomes: is robotic assistance the en- There was only 1 comparison study abling technology that will finally reduce that included abdominal or vaginal co- the exploratory laparotomy rate or horts. Matthews et al9 compared all 4 merely a more expensive tool to accom- approaches (laparoscopic, abdominal, plish the same meager MIS rates? vaginal, and robotic) and reported signif- icantly decreased morbidity in the mini- Perioperative Outcomes mally invasive groups when compared Overall, forest plot analyses (Fig. 2) de- with abdominal hysterectomy. The robotic monstrated equivalent complications, group demonstrated the lowest complica- conversions, and operative time, with tion rate of all 4 cohorts (4.3%). The EBL and length of stay favoring robotic- abdominal group demonstrated higher FIGURE 2. Robotic-assisted laparoscopic hysterectomy (RALH) versus total laparoscopic hysterectomy (TLH). These forest plots show the results of meta-analyses of (A) perioperative complication rates; (B) conversion rates; (C) operative time; (D) uterine weight; (E) estimated blood loss; and (F) length of hospital stay for references5–10 comparing RALH and TLH. Superscript a: perioperative complications included blood transfusions, but not conversions and was calculated as the percent of patients experiencing at least 1 complication. The Nezhat et al 20096 (superscript b) rate represents major complications. The Giep et al 20108 study was a comparison of RALH and laparoscopic-assisted vaginal hysterectomy (superscript c). For Matthews et al 2010,9 the robotic cohort includes RALH and robotic supracervical hysterectomy and the laparoscopic cohort includes TLH, supracervical, and laparoscopic-assisted vaginal hysterectomy. For uterine weight, mean difference was TLH minus RALH due to the assump- tion that the ability to deal with a larger uterus would be advantageous (superscript e), for all other comparisons, a smaller number is considered advantageous and mean difference was calculated as RALH minus TLH. An asterisk designates a community practice. www.clinicalobgyn.com
Robotic Surgery for the General Gynecologists 395 blood transfusions rates, wound infection reporting longer operative times and great- rates, and longer recoveries. Giep et al8 er EBL for the LAVH group. Of note, a compared 3 cohorts (robotic, LAVH, and review article by Kho et al47 reported in- laparoscopic supracervical hysterectomy) creased vaginal cuff dehiscence rates for www.clinicalobgyn.com
396 Payne and Pitter their laparoscopic and robotic cohorts symptoms can occur in up to 81% of when compared with open hysterectomy patients undergoing this procedure.51 or VH. The authors surmised that cuff Historically, there have been 3 ways to closure techniques and thermal effects were remove fibroids from the uterus depend- contributing factors. ing on their location (abdominal, hystero- scopic, and laparoscopic). The most Adoption common technique used to perform myo- The majority of clinicians have reported mectomy is laparotomy. Hysteroscopic extended operating times while perform- myomectomy is reserved for submucous ing robotic-assisted hysterectomy. Ob- myomas 6 cm.12 Endoscopic sutur- studies, by Bell et al25 and Lenihan et al,48 ing and knot tying have been described as specifically addressed the learning curve for a challenge. This is especially true in suture RALH. They reported an initial increase intensive operations such as a myomect- followed by a subsequent decrease in op- omy where the repair of the hysterotomy erative times with mastery at approxi- defect in layers may be required to prevent mately 20 and 50 cases, respectively. uterine rupture during subsequent preg- The overall adoption rate for RALH nancies.14,15 Recently, the use of robotic seems quicker when compared with con- assistance in laparoscopic myomectomy ventional LH. The rate of adoption for has been described in a number of studies, LH demonstrated an approximate 11.8% with the first described in 2004.30 penetrance over 14 years (1989 to 2003).46,49,50 In contrast, over a 6-year Perioperative Outcomes period, adoption of robotic hysterectomy Robotic myomectomy has been shown to has reached 24% (Fig. 3) (Thomson Reu- be equal to traditional laparoscopy with ters In Patient and Out-Patient Views – regards to complications, conversions, Data through end of 2010; Intuitive operative times, and length of stay Surgical Internal Communication, 2011). (Fig. 4). Robotic surgery allows the gen- eral gynecologist to remove larger myo- Cost mas15 and use the same hysterotomy Cost remains a significant concern for closure technique as laparotomy.14 Obe- surgeons and hospital administrators sity did not seem to negatively influence alike. Sarlos et al7 found that the majority the outcome of robotic myomectomy31 of the increased expense was due to ma- (Table 2). Lack of haptics presents a terial costs on a case by case basis. They unique challenge for myomectomy. The did not include the purchase and amorti- use of magnetic resonance imaging map- zation of the robot in their analysis. Total ping and limiting the number of myomas vaginal hysterectomy followed by LH, in patient selection helps to mitigate this have been, and remain less expensive than problem by determining the number and RALH.2 location of the myomas.30 MYOMECTOMY Adoption Myomectomy offers an alternative to There are over 40,000 myomectomy pro- hysterectomy in the treatment of uterine cedures performed in the United States leiomyomata for women whether or not each year.52 For community gynecolo- fertility sparing is an issue. Resolution of gists who want to offer this procedure to www.clinicalobgyn.com
TABLE 1. Robotic Benign Hysterectomy Single-arm Studies Previous Average Abdominal Uterine Surgery, Operative EBL BTx, Conversion, Author (ref) N BMI Weight (g) n (%) Time (min) (mL) LOS (d) Complications, n (%) n (%) n (%) Advincula et al27,* 6 26.0 121.7 6 (100) 254 87.5 1.3 1 (16.7) Postoperative 0 0 (academic) Beste et al20,w 11 26 Range NR 192 Range NR 2 (18.2) Intraoperative 0 1 (9.1) (academic) (49-227) (25-350) Fiorentino et al21 20 NR 98 0 192 81 2 0 (0) Intraoperative 0 2 (10) (academic) 1 (5.0) Postoperative Robotic Surgery for the General Gynecologists Reynolds and 16 27.8 131.5 13 (81) 242 96 1.5 4 (25.0) Postoperative 0 0 Advincula22 (academic) Kho24 91 27.9 135.5 NR 127.8 78.6 1.35 1 (1.1) Intraoperative 0 0 (academic) 7 (7.7) Postoperative Boggess28 152 30.7 347.0 94 (62) 122.9 79.0 1.0 3 (2.0) Intraoperative 0 0 (academic) 5 (3.5) Postoperative Bell et al25 100 31.5 120.2 NR 92.9 NR 1.4 7 (7.0) Perioperative 2 (2) NR (academic) Gocmen et al23 25 28.1 221.9 6 (24) 104.1 38.2 2.8 2 (8.0) Intraoperative 0 0 (academic) 1 (4.0) Postoperative Payne26 100 31.3 212.1 NR 79.6 66.2 1.0 0 0 0 (community) Payne et al29 256 31.1 574.5 142 (55) 151.4 98.9 1.1 9 (3.5) Perioperative 0 4 (1.6) www.clinicalobgyn.com (community) 4 (1.6) Minor 5 (2.0) Major Key: results are mean or median, range, or n (%). Studies were noted as academic or community settings. * All patients had pelvic adhesive disease. w All patients discharged on first postoperative day, except conversion case, 1 cystotomy in a patient with earlier history of cystotomy, was totally independent of and unrelated to the use of the robotic surgical system. BMI indicates body mass index (k/m2); BTx, blood transfusions; EBL, estimated blood loss; LOS, length of hospital stay. 397
398 Payne and Pitter their patients, the learning curve for colpopexy, difficulty of the laparoscopic adapting traditional laparoscopic techni- route, and the durability of the vaginal ques in their treatment armamentarium sacrospinous fixation are of concern. To may be a challenge. There is a statistically date, robotic sacrocolpopexy is less wide- significant decrease in operative times and spread than robotic hysterectomy and blood loss over time when robotic surgery myomectomy, with fewer comparative is applied to myomectomy.53 At the end of articles published.16–18,54 2010, the rate of robotic – assisted laparo- scopic myomectomy reached more than Perioperative Outcomes 10% (Fig. 3) (Thomson Reuters In Patient There have been 2 comparison studies and Out-Patient Views – Data through end reporting on perioperative outcomes.16,17 of 2010; Intuitive Surgical Internal Com- In the study by Geller et al,16 the authors munication, 2011). the rates for conven- reported equivalent perioperative compli- tional laparoscopy were not available. cation rates, a longer operative time, less blood loss, less incidence of postoperative Cost fever, and a shorter length of stay for the The costs associated with robotic myomect- robotic approach. Women in the robotic omy were found to be higher than laparot- group also showed significant improvement omy or traditional laparoscopy.10,12 Both in all preoperative versus postoperative POP- authors included the purchase price and Q values. The study by White et al17 reported amortization of the robot in their calcula- equivalent results for robotic, conventional tions. In the Advincula10 study, there was no laparoscopic, and single-port laparoscopic statistically significant difference in the phy- sacrocolpopexy with respect to all perio- sician reimbursements between cohorts; perative outcomes. however, the mean hospital reimbursements Five of the robotic single-arm studies were higher for the robotic group. (Table 3) reported on conversions, with 2 reporting none40,41 and 3 studies report- ing between 1 and 4 conversions. These SACROCOLPOPEXY were due to limited exposure, intraopera- Historically, the correction of pelvic floor tive bladder injury,42 bowel and bladder defects has been done by vaginal, abdom- adhesions,43 and presacral bleeding.39 inal, or laparoscopic routes. The morbid- One group used a hybrid approach ity associated with abdominal sacro- involving conventional laparoscopy and FIGURE 3. Robotic and Conventional Laparoscopic Adoption Curves. These graphs repre- sent the incidence of robotic (diamond) or laparoscopic (squares) benign hysterectomy (A), myomectomy (B), or sacrocolpopexy (C) procedures performed in the United States. Data for the robotic approach were from industry (Thomson Reuters In Patient and Out-Patient Views – Data through end of 2010; Intuitive Surgical Internal Communication, 2011), starting from the year of Food and Drug Administration approval, with an estimate of the total number of myomectomy procedures performed per year taken from Becker et al.52 Data for laparoscopic benign hysterectomy were taken from Reich et al50 for the start year, from Farquhar and Steiner49 for the midpoints, and from Wu et al46 for the last data point. Data for robotic myomectomy (total number of myomectomy procedures performed per year) were taken from Becker et al,52 with no available data for laparoscopic myomectomy. Data for laparoscopic sacrocolpopexy were taken from Ostrzenski61 for the start year, Nezhat et al,62 and Boyles et al55 (Boyles et al includes all laparoscopic procedures for treatment of pelvic organ prolapse). www.clinicalobgyn.com
Robotic Surgery for the General Gynecologists 399 robotic assistance, where the robot was reported a 1 day length of stay and few only used for suturing and the dissection complications (1 case of bleeding, 2 port was performed laparoscopically.33–38 These site infections, and 1 port site hernia). The studies report high patient satisfaction reported conversions were due to unfa- (100%), low conversion (3.3% to 7.5%), vorable anatomy (dense adhesions or mesh erosion (4.8% to 5%), and recurrence morbid obesity). A cure rate of 100% rates (0 to 3.3%), and operative times that has been reported with follow-up of decreased with experience. In addition, they 3 years.38 www.clinicalobgyn.com
400 Payne and Pitter Adoption There is 1 study by Akl et al42 that found a There are 3 studies giving a comparison 25.4% decrease in robotic sacrocolpo- for operative times between either robotic pexy operative times after the first versus open, robotic versus laparoscopic 10 cases. (including single port), or comparing all 3. The overall adoption rate for robotic In 1 study, robotic sacrocolpopexy took sacrocolpopexy also seems quicker when longer than abdominal sacrocolpopexy.16 compared with conventional laparoscopic The other studies, by White et al17 and sacrocolpopexy. The rate of adoption for Patel et al,18 found no difference in op- laparoscopic sacrocolpopexy demon- erative times. Thus, definitive conclusions strated an approximate 1.2% penetrance regarding operative times remain elusive. over the first 5 years (1992 to 1997).55 In www.clinicalobgyn.com
Robotic Surgery for the General Gynecologists 401 contrast, the rate of robotic sacrocolpo- medical, surgical, or a combination of pexy reached 27% over a 6-year period both. Other than reports combining re- (2005 to present) (Fig. 3) (Thomson Reu- section of disease with other benign gyne- ters In Patient and Out-Patient Views – cological procedures, there are few studies Data through end of 2010; Intuitive Surgi- specifically published regarding the use of cal Internal Communication, 2011). robotic assistance with endometriosis. The majority of publications are case Cost presentations involving resection of infil- Two comparison studies report on cost of trating disease, with 1 comparative robotic, conventional laparoscopic, and ab- study.19 Examples of case studies include dominal sacrocolpopexy.18,54 Of the 2 stu- publications by Sener et al in 2006,56 Liu dies reporting on cost, 1 used a modeling et al in 2008,57 and Chammas et al 2008.58 approach54 and the other calculated the actual direct and indirect costs for 5 cases. These 5 cases were selected for their lack of Perioperative Outcomes any concomitant procedures.18 Both studies Nezhat et al19 recently published a study reported higher costs with a robotic ap- comparing conventional laparoscopy with proach compared with abdominal surgery, robotic-assisted surgery in the treatment of but the Patel et al18 study found equivalent endometriosis. They found no statistical sig- overall costs for robotic and laparoscopy. nificance with regards to complications, con- versions, or blood loss. Operative times were longer with the robotic group. Nezhat et al19 ENDOMETRIOSIS concluded that while there seems to be no The treatment options for endometriosis advantage for robotic-assisted surgery in by the general gynecologist include early stage endometriosis (stages 1 and 2), FIGURE 4. Robotic myomectomy (RM) versus laparoscopic myomectomy (LM) or abdom- inal myomectomy (AM). These forest plots show the results of the meta-analyses of (A) perioperative complication rates; (B) conversion rates; (C) operative time; (D) myoma weight; (E) estimated blood loss; and (F) length of hospital stay for references11–16 comparing RM and LM or RM and AM. Superscript a: perioperative complications included blood transfusions, but not conversions and was calculated as the percent of patients experiencing at least 1 complica- tion. The Nezhat 200912 (superscript b) complication rate represents major complications and myoma weight includes 47% intramural myomas in the robotic group and 54% intramural myomas in the laparoscopic group. The Ascher-Walsh and Capes 201014 (superscript c) complication rate represents febrile morbidity. In Bedient et al 200911 (superscript d) myoma weight includes 66% subserosal, 59% intramural, and 16% submucosal in the robotic group and 67% subserosal, 72% intramural, and 34% submucosal in the laparoscopic group. For Barakat et al 201115 (superscript e), myoma weight includes 10% broad ligament, 36% subserosal, 79% intramural, 24% submucosal, 12% pedunculated, and 3% multiple infiltration in the robotic group; 3% broad ligament, 28% subserosal, 59% intramural, 10% submucosal, 23% peduncu- lated, and 8% multiple infiltration in the laparoscopic group; and 0.3% cervical, 3% broad ligament, 26% subserosal, 79% intramural, 14% submucosal, 15% pedunculated, and 6% multiple infiltration in the abdominal group. For myoma weight, mean difference was LM minus RM and AM minus RM due to the assumption that the ability to deal with a larger myoma would be advantageous (superscript d), for all other comparisons, a smaller number is considered advantageous and mean difference was calculated as RM minus LM or RM minus AM. Diff indicates difference. There were no reports from community practices. www.clinicalobgyn.com
www.clinicalobgyn.com 402 Payne and Pitter TABLE 2. Robotic Myomectomy Single-arm Studies Myoma Largest Myoma Myoma Diameter No. Location/ Operative EBL LOS BTx n Conversion, Pregnancy Author N BMI Weight (g) (cm) Myomas Type Time (min) (mL) (d) Complications (%) n (%) Outcome Advincula 35 25.3 223 7.9 48 8 Ant. 231 169 1 1 Pneumonia 0 3 (8.6) No et al30 8 Post. 1 Port site pregnancies (academic) 7 Ant. infection reported Fundal 6 Post. Fundal 11 Fundal 3 Broad Lig. 5 Ped. George 77 29.1 235 6.8 NR NR 195 100 1 1 Ileus 2 (2.6) 1 (1.3) NR et al31 (academic) Lonnerfors 13 All were 132 50 1 0 Major 6/ of 8 et al32 intramural pregnancies (academic) reported Key: results are mean or median, or n (%). Studies were noted as academic or community settings. Ant., indicates anterior; BMI, body mass index (k/m2); BTx, blood transfusions; EBL, estimated blood loss; Lig., ligament; LOS, length of hospital stay, Ped; pedunculated; Post., posterior.
Robotic Surgery for the General Gynecologists 403 FIGURE 5. Fagin Efficiency Model. This diagram shows both the old approach of serial task execution and the new approach of parallel task execution. For each diagram, external I represents the time during the surgical procedure for patient 1, internal represents the time in between cases (room changeover time), and external II represents the time during the surgical procedure for patient 2. Each box represents 1 task, with stacked boxes representing tasks occurring at the same time. The number of tasks planned for any given moment determines how many people are needed. The second goal is to move tasks from internal to external. Diagrams modified from Hemal et al.60 there may be some advantage in advanced Adoption of Robotics: A Model disease requiring extensive resection. Similar for the General Gynecologist conclusions were reached by Sener et al56 and Liu et al57 in their case studies describing extensive bladder endometriosis with ROBOTIC TEAM MODEL resection. Naturally, for the general gynecologist, there are concerns regarding not only the validity, but the everyday adoption and Adoption efficiency of new technology. The major- There are no studies that specifically ad- ity of robotic training in benign gynecol- dress learning curves or adoption rates for ogy has been of the postgraduate variety the robotic treatment of endometriosis. with little to no residency training since its Food and Drug Administration approval in 2005. To date, the common pathway to Cost competency has been curiosity, online There are no studies to date that address testing, and animal laboratory protocols, the costs associated with using robot as- followed by an average of 3 proctored sistance to treat endometriosis. cases in the training surgeons’ hospital.48 www.clinicalobgyn.com
www.clinicalobgyn.com 404 TABLE 3. Robotic Sacrocolpopexy Single-arm Studies Recurrence Concurrent Mesh of Payne and Pitter procedures, Operative EBL LOS Complications, Conversion, Ave. Follow- Erosion, Symptoms, Patient Author N BMI n (%) Time (min) (mL) (d) n (%) n (%) up (mo) Pain n (%) n (%) Satisfaction Daneshgari 15 NR 8 (53) UI 317 81 2.4 1 (7) Periop 3 (20) 3.1 NR 0 0 NR et al43 (academic) Shariati 77 26.1 3 (4) VH NR NR 2 14 (18.2) Periop 1 (1.3) 7 NR 3 (4) 1 (1.3) 50 of 53 et al39 33 (43) UI prolapse would (academic) 65 (84) RR to introitus do again 3 (5.7) still had prolapse symptoms Kramer 21 NR None 194
Robotic Surgery for the General Gynecologists 405 FIGURE 6. Fagin Flowchart of Tasks. This flowchart demonstrates what task each member of the team should be performing at any given time during a robotic procedure. Trigger points provide transitions that break down the case into manageable increments. Modified from Hemal et al.60 Utilization of this training paradigm has to organize and standardize an enthu- produced many successful and some sub- siastic, efficient robotic culture. The fol- par hospital programs. The authors, who lowing are some key points to help en- have had the privilege of contact with hance success for the general gynecologist many programs nationwide, feel that the adopting robotic-assisted technology. commonalities shared by both successful and unsuccessful programs warrant dis- Dedicated Leadership cussion. In general, success does not seem Attitude matters. Everyone matters. It is to depend on the talents of the individual of vital importance that any program surgeon as much as the hospital’s ability develops a cooperative team from top to www.clinicalobgyn.com
406 Payne and Pitter bottom. This must start with administra- useful analogy is learning to drive a stan- tors and end with those individuals re- dard automobile. The intelligent person sponsible for mopping the floor between would drive around the parking lot and cases. There must be a shared vision and master the nuances before hitting rush enthusiasm with universal ‘‘buy in’’ hour traffic on the interstate. In addition, throughout the team. A typical leadership video is of great use to the new robotic team would have representatives including surgeon. Taping and reviewing each sur- surgeons, anesthesiologists, administra- gery will help improve all aspects of ro- tors, operating room managers, robotic botic cases. By reviewing videos, lessons coordinators, circulators, first assistant, can be learned by all participants involved and scrub technicians. It is of critical im- in the procedure. portance that negative attitudes not be allowed to interfere with the success of the Dedicated Robotic Team team. In fact, with regards to the circulator, Of vital importance is a dedicated robotic first assistant, and scrub tech positions, it is operating room team. Assignment of ran- easier to build a team with enthusiasm and dom personnel into the robotic suite is a inexperience than with experience and common program hobbling decision. The negativity. majority of highly successful programs treat the robotic operating room as they Dedicated Surgeons do the transplant or cardiovascular arena. The surgeon must be open to change to Individuals with the appropriate attitude master this new technology. They must be and skill set are welcomed, randomly as- comfortable taking a step back to make signed personnel are not. The entire team the leap forward. They must also have a must be able to anticipate the require- surgical case volume that allows for main- ments of an operation ahead of time. tenance of their newly acquired skill set. The primary surgeon must give power to Physicians with
Robotic Surgery for the General Gynecologists 407 Circulator suture needs, and a minor tray for trocar This individual should be responsible for closure. Ideally, all should be ready 1 step the overall flow of the room. Why the ahead of the surgeon’s needs. circulator and not the surgeon? Because the circulator is there everyday for multi- Team Communication ple cases while most surgeons are there The concept of intraoperative ‘‘read- once a week. Less variance plus more back’’ is essential. There is a tendency standardization equals more efficiency for the surgeon to bury themselves in the and safety. The circulator is in the perfect console and block out the operating position to touch all aspects of the cases as room. ‘‘Readback,’’ as adopted in the they are being performed on a daily basis. airline industry, clarifies lines of commu- They are responsible for first and second nication between critical participants. timeouts during the case. The first time Communication between the surgeon out to assure the right patient, allergies, and the robotic team should be repeated and procedure, and the second at the at each instrument exchange and transi- conclusion of the case to review and en- tion point during surgery. In this way, able any team member to voice ‘‘real there will be no false assumptions regard- time’’ recommendations for improvement ing each team member’s intentions during of future cases. the case. First Assistant The surgeon’s bedside colleague plays a OPERATING ROOM EFFICIENCY critically important role. This person MODEL should be very adept at presenting tissue A primary concern in the successful adop- to the surgeon by uterine manipulation tion of any robotic program is operating and hand held laparoscopic instruments. room efficiency. The ability to perform at Some institutions divide uterine manipu- least 4 to 5 robotic cases per day is para- lation and laparoscopic assistance be- mount in helping to address both cost and tween 2 people. If this is the case, the access concerns regarding this emerging most experienced assistant should manip- technology. Standardization of proce- ulate the uterus as this is the more difficult dures reduces errors, improves quality, of the 2 tasks. Just as in open surgery, the and increases revenue.59 Randy Fagin, surgeon should be free to operate with MD recently published a model concen- both hands. It is the first assistant’s job to trating on these universal concerns.60 retract and present the case accordingly. Fagin’s model puts forth the concept of Others find that the forth robotic arm is parallel tasking to achieve efficiency in the an adequate substitute during retraction robotic operating room. Fagin argues or manipulation. that all that is needed to create efficiency, maintain safety, and achieve 20 minutes Scrub Technician turnover times in the robotic operating This team member should be proficient in room are 5 dedicated people, 2 instrument organizing the surgeon’s ‘‘pick lists’’ for sets, and mastering the concept of parallel appropriate cases. It is crucial that the tasking. Internal tasks, external tasks, and scrub technician master transition points parallel tasking (task overlap) are re- during the surgery and insure that they viewed here and shown in Figure 5. Ex- evolve in an efficient manner. Examples ternal tasks are defined as functions that would be organizing a Mayo tray for the can be done while the operating room is uterine manipulator, camera set up, pla- actively engaged in a surgical procedure; cement of initial instruments, appropriate they are external to the procedure being www.clinicalobgyn.com
408 Payne and Pitter performed (ie, filling out paperwork). In- Conclusions ternal tasks are defined as those that must Robotic assistance for the treatment of be done while the operating room is benign gynecological conditions includ- ‘‘down’’ and not engaged in a surgical ing hysterectomy, myomectomy, sacro- procedure (ie, mopping the floor). Task colpopexy, and endometriosis results in overlap is defined as performing indivi- decreased blood loss and length of stay. dual tasks in parallel rather than one after However, operative time and cost are the other in a series. The primary goals of often increased. These findings hold true the model are to convert internal tasks to not only for academic centers but also in external tasks and then create task community settings involving the general overlap. gynecologist. Cost, it is fair to say, is the primary concern regarding robotic-as- Internal Converted to External sisted procedures. Start up, instrument, Move tasks that are normally done when and intraoperative costs must be weighed the patient is out of the room and perform against any global savings that a reduc- them with the patient in the room. For tion in the exploratory laparotomy rate example, setting up the back table and might afford society. As with any new draping the robot while the anesthesiolo- technology that starts off costly (ie, cell gist performs intubation. In addition, the phones, personal computers, flat screen robot can be undraped, the back table TVs), time and competition usually work cleared, and the instruments sent to sterile in tandem to reduce expenses to society’s processing while the surgeon closes the advantage. The singular goal in any ad- trocar sites. vancement in the surgical sciences is im- proved patient outcome. Scrutiny and Task Overlap healthy skepticism of any new technology Traditionally, tasks are performed by the are paramount and should be expected. OR team in a series. For example, the We should also be careful not to cling to team sets up the back table then drapes habits merely because they are familiar, for the robot then gets the patient. By con- progress is often unforgiving for those who trast, each of these tasks can, and should insist on remaining in their comfort zones. be performed by 1 person each, thus Either we find a better way to teach our allowing the group to work in a parallel current MIS techniques and become suc- manner: 1 person drapes the robot, while cessful in their reproducibility, or ultimately a second person sets up the back table, our failure in this endeavor will, and should, while the anesthesiologist and assistant go make way for new advancements. get and then intubate the patient. It would seem that robotic surgery is an A flow diagram (Fig. 6) demonstrates enabling tool that may provide a mechan- what task each member of the team ism for an easier transition to advanced should be performing at any given time laparoscopy. However, as with any surgi- during a robotic procedure. Trigger cal approach, a working knowledge of the points provide transitions that break pelvic anatomy is an absolute prerequisite down the case into manageable incre- for the successful incorporation of this ments. In this manner, the robotic room tool. Certainly, more randomized and becomes an efficient theater of operation controlled studies are needed. The differ- and allows accessibility for more sur- ence in adoption rates could be signaling a geons. In addition, efficiency allows more shifting paradigm with this new techno- cases to be performed each day, thus logy. The future will demonstrate whether increasing revenue and decreasing the in- robotic assistance provides the answer to itial start up investment for the hospital. the challenge put forth by the American www.clinicalobgyn.com
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