Surgical outcomes in gynecologic oncology in the era of robotics: analysis of first 1000 cases

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Surgical outcomes in gynecologic oncology in the era of robotics: analysis of first 1000 cases Pamela J. Paley, MD; Dan S. Veljovich, MD; Chirag A. Shah, MD, MPH; Elise N. Everett, MD; Amy E. Bondurant, MD; Charles W. Drescher, MD; William A. Peters III, MD OBJECTIVE: We sought to examine outcomes in an expanding robotic

surgery (RS) program. STUDY DESIGN: In all, 1000 women underwent RS from May 2006 through December 2009. We analyzed patient characteristics and outcomes. A total of 377 women undergoing RS for endometrial cancer staging (ECS) were compared with the historical data of 131 undergoing open ECS. RESULTS: For the entire RS cohort of 1000, the conversion rate was

2.9%. Body mass index increased over 3 time intervals: T1 ⫽ 26.2, T2 ⫽ 29.5, T3 ⫽ 30.1 (T1:T2, P ⫽ .01; T1:T3, P ⫽ .0001; T2:T3, P ⫽ .037). Increasing body mass index was not associated with increased

major complications: T1 ⫽ 8.7%, T2 ⫽ 4.3%, T3 ⫽ 5.7%. In the ECS cohort, as compared with open ECS, women undergoing RS had lower blood loss (46.9 vs 197.6 mL, P ⬍ .0001), shorter hospitalization (1.4 vs 5.3 days, P ⬍ .0001), fewer major complications (6.4% vs 20.6%, P ⬍ .0001), with higher lymph node counts (15.5 vs 13.1, P ⫽ .007). CONCLUSION: RS is associated with favorable morbidity and conver-

sion rates in an unselected cohort. Compared to laparotomy, robotic ECS results in improved outcomes. Key words: endometrial carcinoma, robotic surgery, surgical morbidity

Cite this article as: Paley PJ, Veljovich DS, Shah CA, et al. Surgical outcomes in gynecologic oncology in the era of robotics: analysis of first 1000 cases. Am J Obstet Gynecol 2011;204:551.e1-9.

M

inimally invasive surgery (MIS) is now accepted as an integral part of gynecologic surgery. While the reproducibility and feasibility of MIS in gynecology has motivated surgeons to expand the use of laparoscopy in their practices, the implementation of laparoscopy for more advanced procedures

From Pacific Gynecology Specialists Inc, Swedish Medical Center, Seattle, WA. Presented at the 77th Annual Meeting of the Pacific Coast Obstetrical and Gynecological Society, Kohala Coast, HI, Sept. 29-Oct. 3, 2010. Received Sept. 13, 2010; revised Nov. 23, 2010; accepted Jan. 26, 2011. Reprints: Pamela J. Paley, MD, Pacific Gynecology Specialists Inc, 1101 Madison St., Suite 1500, Seattle, WA 98104. [email protected]. Disclosure: Dr Paley owns 85 shares of Intuitive Surgical Inc, and has received speakers’ honoraria from this company. Dr Veljovich owns 200 shares of Intuitive Surgical Inc, and has received speakers’ honoraria from this company. Intuitive Surgical Inc manufactures the daVinci surgical system used in this paper and provided no financial support for this study. 0002-9378/$36.00 © 2011 Mosby, Inc. All rights reserved. doi: 10.1016/j.ajog.2011.01.059

has been precluded by the technical and mechanical limitations of the equipment. Accordingly, these limitations have driven the technological evolution of MIS tools. Robotic-assisted MIS effectively surmounts the technical obstacles posed by traditional laparoscopy by incorporating 3-dimensional visualization, articulated instrumentation, motion scaling, enhanced stability of the operative image and instrumentation, and optimization of ergonomics and autonomy. We have previously reported clinical outcome data arising from the first year of incorporation of robotic surgery (RS) into our gynecologic oncology practice.1 Analysis of our initial experience suggests that compared with comparable open cases performed the year prior to, and during the first year of our robotic experience, RS offered advantages that include decreased estimated blood loss (EBL), faster recovery, and a trend toward reduced major complications (MC). Equally important is the fact that we were able to dramatically expand our MIS program utilizing this technology. Given these encouraging findings, but recognizing that careful patient selection had been critical to our success, we looked forward while posing several

questions. Would our complication rate stay low as we expanded a robotics approach to women with more complex clinical problems, as well as those unselected for body mass index (BMI) or previous number of abdominal surgeries? Additionally, would our conversion rate remain low when a higher proportion of obese women were included in the robotics cohort? What would the impact of incorporating resident and fellow robotics training have on outcomes? Finally, would our efficiency improve? We now report the outcomes of the first 1000 women who consecutively underwent RS upon referral to our gynecologic oncology practice.

M ATERIALS AND M ETHODS One thousand women underwent RS from May 2006 through December 2009. Initially, the first and second authors completed the credentialing requirements in May 2006, and within 4 months 2 additional gynecologic oncologists completed training. In May 2009 a fifth attending gynecologic oncologist joined our practice and began performing robotic cases. Resident involvement began with the 17th case. In November 2006, we began training our gynecologic oncology fellows on the console (case 57).

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FIGURE 1

Trend in minimally invasive surgery

8 800 6 600 4 400

MIS

2 200 0

Open n

Trend in minimally invasive surgery (MIS) prerobotics and postrobotics; 2005 through 2006 is year prior to initiation of robotics; 2006 through 2007 is initial year of performing robotic surgery in our practice. Percentage of MIS in each year in chronologic order is 9%, 17%, 26%, and 36%. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

All cases were performed with the da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA). Our RS technique has been previously described.1 In the first year, data collection and analysis were performed prospectively for a quality assurance project per request of Swedish Cancer Institute Cancer Committee. Institutional review board approval was obtained upon com-

pletion of the quality assurance project. A database in compliance with the Health Insurance Portability and Accountability Act of 1996 was created for all patients who underwent RS during the study period. We prospectively collected data including age, BMI, number of previous abdominal surgeries, EBL, operative times (OT), pathologic findings such as lymph node count (LN),

TABLE 1

Robotic surgery: major complications (n ⴝ 1000) Complication

n

Percent

major and minor surgical complications, and length of stay (LOS). Calculated OT for RS was from placement of the uterine manipulator to skin closure, or incision to skin closure for those cases in which a uterine manipulator was not utilized. Postoperative complications were included if occurring up to 6 weeks postoperatively. Vaginal cuff separation and/or dehiscence were included regardless of the number of weeks from the surgical procedure. LOS included the time from arrival in the operating room to the time of discharge. Conversion to laparotomy was defined as any laparotomy required to complete the planned robotic procedure including mini-laparotomy for organ removal even if the entire procedure was performed robotically up to the point of specimen delivery. For patients with biopsy-proven endometrial carcinoma, the performance of and extent of lymphadenectomy was at the discretion of the attending surgeon. Data analysis was performed using software (Stata, version 11.0; StataCorp, College Station, TX). Descriptive statistics were initially performed, followed by data analysis to determine whether there was a parametric vs nonparametric distribution. In most cases, a nonparametric distribution was observed; therefore, the Kruskal-Wallis 2-sample rank sum test was utilized to determine whether there was a statistically significant difference between groups. When the distribution appeared to be parametric, a ␹2 test or Student t test was used (a 2-tailed test was utilized, with alpha level ⬍0.05 considered significant).

Major vessel injury

3

0.3

Intraoperative hemorrhage

1

0.1

Postoperative anemia requiring transfusion

5

0.5

Deep venous thrombosis or pulmonary embolus

5

0.5

Ureteral stricture/injury

2

0.2

Ileus

7

0.7

R ESULTS

12

1.2

Small bowel obstruction

4

0.4

Cuff dehiscence or separation

6

0.6

Enterotomy

1

0.1

Postoperative vault prolapse

1

0.1

Chylous ascites

1

0.1

Cystotomy

2

0.2

Transient postoperative arrhythmia//labile hypertension/fluid overload

7

0.7

57

5.7

First consecutive 1000 robotic cases The most common indications for surgery in our robotics cohort were endometrial carcinoma (n ⫽ 377) and adnexal mass (n ⫽ 194). The remaining indications were genetic predisposition to ovarian and tubal cancer (n ⫽ 145), cervical carcinoma in situ or adenocarcinoma in situ or benign uterine indication (n ⫽ 85), cervical or endometrial cancer amenable to radical hysterectomy and staging (n ⫽ 65), ovarian or fallopian tube cancer (n ⫽ 59), locally ad-

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Infection

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Total

..............................................................................................................................................................................................................................................

Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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TABLE 2

Major complications by year (n ⴝ 1000) Year

Major complications, n

Major comorbidities, n

2006 through 2007 T1

13/149 (8.7%)

35/149 (23.5%)

26.5 (17.4–49.4)

2007 through 2008 T2

14/323 (4.3%)

102/323 (31.6%)

29.5 (14.6–69.2)

.01

2008 through 2009 T3

30/528 (5.7%)

239/529 (45.2%)

30.1 (15.9–70.1)

.037 .0001c

Mean BMI (range)

P value for BMI comparisons

................................................................................................................................................................................................................................................................................................................................................................................ a ................................................................................................................................................................................................................................................................................................................................................................................ b

................................................................................................................................................................................................................................................................................................................................................................................

BMI, body mass index. a

BMI comparison T1 vs T2; b BMI comparison T2 vs T3; c BMI comparison T1 vs T3.

Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

vanced cervical cancer (n ⫽ 17), complex atypical endometrial hyperplasia (n ⫽ 27), vaginal vault prolapse (n ⫽ 19), vaginal intraepithelial neoplasia (n ⫽ 3), and other (n ⫽ 8). Surgical procedures included simple hysterectomy with or without adnexectomy (n ⫽ 461), hysterectomy with bilateral salpingo-oophorectomy and pelvic with or without periaortic lymphadenectomy (n ⫽ 277), adnexectomy (n ⫽ 95), radical hysterectomy with lymphadenectomy (n ⫽ 65), staging pelvic and periaortic lymphadenectomy for either incompletely staged endometrial/ cervical cancer or surgical staging of cervical cancer (n ⫽ 50), resection and staging of ovarian or fallopian tube carcinoma (n ⫽ 23), sacrocolpopexy (n ⫽ 12), sacrocolpopexy with hysterectomy (n ⫽ 7), myomectomy (n ⫽ 5), hysterectomy/bilateral salpingo-oophorectomy with upper vaginectomy (n ⫽ 2), upper vaginectomy (n ⫽ 1), oophoropexy prior to radiation (n ⫽ 1), and trachelectomy with lymphadenectomy (n ⫽ 1). The number of MIS cases performed in our practice has continued to grow

each year since the inception of our robotics program. This trend is illustrated in Figure 1. As shown, in the year preceding the introduction of robotics in our practice, only 9% of all cases performed at our primary institution were approached laparoscopically. By the third year of our robotics experience, the proportion of MIS cases had grown to 36%. Within the entire RS cohort the total complication rate was 9.9%. The MC rate was 5.7%, while minor complications occurred in 4.2% of patients. Details of the MC are listed in Table 1. The most common MC were infectious in 1.2%, ileus in 0.7%, and cuff dehiscence in 0.6%. Infectious complications included vaginal cuff abscess requiring percutaneous drainage and antibiotics (n ⫽ 6), vaginal cuff cellulitis requiring intravenous antibiotics (n ⫽ 2), vaginal cuff cellulitis requiring only oral antibiotics (n ⫽ 2), postoperative acute cholecystitis (n ⫽ 1), and fatal sepsis arising from bacterial endocarditis in a patient with a mechanical valve (n ⫽ 1). We compared trends in BMI and preexisting medical comorbidities in the

early, middle, and final thirds of the study time interval (T1-T3). BMI increased significantly with increasing robotic experience: T1 ⫽ 26.2, T2 ⫽ 29.5, T3 ⫽ 30.1 (T1 vs T2, P ⫽ .01; T1 vs T3, P ⫽ .0001; T2 vs T3, P ⫽ .037). Despite a significant and steady rise in BMI, a concomitant rise in MC did not occur (Table 2). The MC rate remained low throughout each subsequent time interval: T1 ⫽ 8.7%, T2 ⫽ 4.3%, T3 ⫽ 5.7%. The conversion to laparotomy rate in the entire robotics cohort was low at 2.9%. Comparing the conversion rates by time interval, despite a steady rise in BMI, an escalation in conversions was not realized: T1 ⫽ 4.0%, T2 ⫽ 2.5%, T3 ⫽ 2.8% (Table 3). Conversion rates were examined in each of 3 BMI categories. Conversion rates remained low in all BMI categories: 2.7% in normal-weight and overweight women, 2.1% in obese women with BMI between 30-40, and 6.1% in morbidly obese women with BMI ⬎40. The most prevalent reasons for converting to laparotomy were adhesions precluding acceptable exposure (1.2%), unanticipated carcinomatosis

TABLE 3

Conversion to laparotomy by year (n ⴝ 1000) Mean BMI (range)

P value for BMI comparisons

Time interval

Conversions, n

Conversions

All

29/1000

2.9%

2006 through 2007 T1

6/149

4.0%

26.5 (17.4–49.4)

2007 through 2008 T2

8/323

2.5%

29.5 (14.6–69.2)

.01

2008 through 2009 T3

15/528

2.8%

30.1 (15.9–70.1)

.037 .0001c

................................................................................................................................................................................................................................................................................................................................................................................ ................................................................................................................................................................................................................................................................................................................................................................................ a ................................................................................................................................................................................................................................................................................................................................................................................ b

................................................................................................................................................................................................................................................................................................................................................................................

BMI, body mass index. a

BMI comparison T1 vs T2; b BMI comparison T2 vs T3; c BMI comparison T1 vs T3.

Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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TABLE 4

Vaginal cuff dehiscence by year (n ⴝ 832) Year

Total robotic cases with cuff closures

Cuff dehiscence/ separation, n

Cuff dehiscence/ separation

Mean BMI (range)

2006 through 2007 T1

113

3

2.6%

26.5 (17.4–49.4)a

2007 through 2008 T2

277

2

0.72%

29.5 (14.6–69.2)

2008 through 2009 T3

442

1

0.22%

30.1 (15.9–70.1)

................................................................................................................................................................................................................................................................................................................................................................................ b ................................................................................................................................................................................................................................................................................................................................................................................ c ................................................................................................................................................................................................................................................................................................................................................................................

BMI, body mass index. P values for BMI comparisons: a T1 vs T2, P ⫽ .01; b T2 vs T3, P ⫽ .037; c T1 vs T3, P ⫽ .001. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

requiring laparotomy for optimal debulking (0.7%), and inability to deliver an intact specimen vaginally (0.4%). Rare indications for conversion included extensive subcutaneous emphysema that occurred in 2 cases, and major vessel injury, poorly controlled bleeding, ureteral injury, and robotic malfunction each occurring in 1 instance in the study interval. There were 832 of the 1000 robotic cases in which colpotomy and vaginal cuff closure was a component of the case. Vaginal cuff dehiscence or separation occurred in 6 of these 832 women for an overall cuff dehiscence rate of 0.72%. There was a steady decline in vaginal cuff dehiscence with increasing experience: T1 ⫽ 2.6%, T2 ⫽ 0.72%, T3 ⫽ 0.22% despite a significant rise in BMI with each subsequent time period (Table 4). The impact of fellow and resident involvement was evaluated. Trainees participated in 460 of the first 1000 robotic procedures in our primary institution. As shown in Table 5, there were no significant differences in total complications, MC, or minor complications, or conversions to laparotomy when resi-

dents and fellows participated compared to cases performed exclusively by attending gynecologic oncologists. Recognizing that gynecologic oncology fellows were more likely to perform a more substantial proportion of, if not the entire procedure as compared to resident physicians, we compared outcomes in cases with resident vs fellow participation. No differences were observed in total complications, MC, or minor complications, or conversion to laparotomy (Table 6).

Robotic vs open endometrial cancer cases The proportion of endometrial cancer patients treated with MIS in the year prior to implementing robotics in our practice and the 3 subsequent years is shown in Figure 2. A subset of 377 women who underwent endometrial cancer staging (ECS) with RS were compared to 131 women who underwent abdominal hysterectomy with surgical staging (72 with pelvic and periaortic lymphadenectomy and 59 with pelvic nodes only) the year prior to initiation of RS and our first year of robotics implementation. Our analysis excluded women undergoing ECS at hospitals outside of

TABLE 5

Impact of fellow and resident training on complications (n ⴝ 1000) Variable

Fellow/resident, n

Attending only, n

Total cases

460

540

P value

..............................................................................................................................................................................................................................................

Total complications

36 (7.8%)

63 (11.7%)

.2715

Major complications

20 (4.3%)

37 (6.9%)

.0889

Minor complications

16 (3.5%)

26 (4.8%)

.2941

Conversions to laparotomy

18 (3.9%)

11 (2.0%)

.0782

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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our primary institution or women, who on review of the operative note, had additional procedures (ie, colon resection) that would invalidate comparisons between groups. Comparison of pertinent clinical variables in the ECS robotic and laparotomy cohorts are shown in Table 7. There were no significant differences in the group with respect to age, BMI, medical comorbidities, or number of previous abdominal surgeries. OT were longer in the robotics group, and LN, LOS, and EBL were superior in the robotics cohort. Complications are compared between robotic and open ECS in Table 8. Women undergoing open ECS suffered substantially higher MC as compared to women undergoing RS (20.6% vs 6.4%, P ⬍ .0001). The most significant reductions in MC with robotics were realized in wound separation or dehiscence, infectious complications, and ureteral injury or acute renal failure. Of importance, the incidence of vaginal cuff dehiscence was higher in the robotics group (1.2% vs 0%). The intensive care unit admission rate (3.8% vs 0.5%, P ⬍ .0027) and mortality rate (0.27% vs 1.5%, P ⫽ .05) were lower in the robotics cohort. A subset analysis of outcomes in our obese patient population was performed. Of the women included in the ECS subgroup, 136 women undergoing robotic management and 47 women undergoing laparotomy were obese with a BMI between 30-40. There was approximately a 10-fold increase in the incidence of MC in obese women with open surgery as compared to robotics (Table 9). The most significant reductions were noted in wound dehiscence or separa-

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www.AJOG.org tion and infectious complications. A comparison of operative morbidity was performed in women meeting criteria for morbid obesity with a BMI ⱖ40 (Table 10). Fifty-three women in the robotic cohort and 23 women undergoing laparotomy were included in this group. A substantial reduction in MC was noted in the robotics group (11.3% vs 43.5%, P ⬍ .006). The most significant declines were seen in wound separation and dehiscence, infectious complications, and acute renal failure. There were 347 of the 377 robotic endometrial cancer cases in which colpotomy and vaginal cuff closure was a component of the case. The overall incidence of vaginal cuff dehiscence or separation was 1.2%. There was a steady decline in the vaginal cuff dehiscence and separation rate in each year of increasing experience despite a rise in average BMI (Table 11). The total conversion to laparotomy rate in the robotic endometrial cancer cohort was 3.5%. The most common reasons for conversion to laparotomy were adhesions lending to suboptimal visualization (n ⫽ 4), inability to deliver a cancer-containing uterus intact (n ⫽ 4), and unanticipated carcinomatosis requiring laparotomy for optimal resection (n ⫽ 3). Significant carbon dioxide retention and a major vessel injury each resulted in conversion in 1 case in the endometrial cancer group. In addition, we compared conversion rates by BMI category. Conversion rates remained low in each of the BMI categories (Table 12). Finally, OT in the first, second, and third study intervals were tabulated to assess trends in efficiency. Of the 377 women in the ECS robotics cohort, 30 were referred after hysterectomy and incomplete ECS and subsequently underwent robotic lymphadenectomy and thus are not included in the OT analysis. Of the remaining 347 women, 247 (72%) underwent robotic hysterectomy, bilateral salpingo-oophorectomy, and pelvic with or without limited periaortic lymph node sampling (n ⫽ 109) or pelvic and periaortic lymphadenectomy (n ⫽ 138). Despite a significant rise in BMI during each subsequent time interval, OT decreased significantly (Tables 13 and 14). In the open cohort, 44% of women un-

TABLE 6

Impact of fellow vs resident training on complications and conversions (n ⴝ 1000) Variable

Residents (n ⴝ 189), n

Fellow (n ⴝ 271), n

P value

Total complications

14 (7.4%)

22 (8.1%)

.3903

Major complications

9 (4.8%)

11 (4.1%)

.6416

Minor complications

5 (2.6%)

11 (4.1%)

.2084

Conversion to laparotomy

9 (4.8%)

9 (3.3%)

.7830

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

derwent pelvic and periaortic lymphadenectomy, while in 56% pelvic lymphadenectomy with or without periaortic node sampling or pelvic node sampling was performed.

C OMMENT MIS has been championed as a means of reducing surgical morbidity. Despite documentation of the benefits of MIS for ⬎3 decades, widespread adoption of MIS, particularly in gynecologic oncology, has been lacking. Childers et al2,3 demonstrated that laparoscopic hysterectomy with pelvic lymphadenectomy was feasible in 1992, and that laparoscopic periaortic lymphadenectomy was feasible just 1 year later. In a prospective comparison of laparoscopy to laparotomy for ECS, the Lap-2

trial, conducted by the Gynecologic Oncology Group (GOG), demonstrated the feasibility of laparoscopy with equivalent positive cytology rates, proportion of advanced stage diagnoses, and node positivity rates as compared to laparotomy. Laparoscopy had an improved safety profile with fewer grade ⱖ2 postoperative events, and shorter hospital stay. Laparoscopy was associated with less postoperative pain, earlier resumption of normal activities, and earlier return to work. Furthermore, significant improvement in quality of life at weeks 1, 3, and 6 postoperatively was documented in the laparoscopy cohort.4 However, a survey of the Society of Gynecologic Oncologists members and other regional reports have documented the severe

FIGURE 2

Growth in minimally invasive endometrial cancer staging

Robotic endometrial cancer staging (ECS) growth; 2005 through 2006 represents proportion of ECS cases performed laparoscopically in our practice; 2006 through 2007 represents first year of integration of robotic surgery in our practice. MIS, minimally invasive surgery. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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TABLE 7

Comparison of major complications in robotic and open endometrial cancer cohorts Complication

Robotic, n ⴝ 377

Open, n ⴝ 131

Cardiac

1 (0.26%)

5 (3.8%)

Pulmonary

3 (0.79%)

1 (0.76%)

DVT/PE

3 (0.79%)

1 (0.76%)

Infectious

4 (1.1%)

6 (4.6%)

ARF/ureteral injury

0

4 (3.0%)

Wound dehiscence/separation

0

9 (6.9%)

Major vessel injury

1 (0.26%)

0

Anemia requiring transfusion

2 (0.53%)

1 (0.76%)

Labile blood sugar

2 (0.53%)

0

Ileus/SBO

2 (0.53%)

0

Cystotomy

1 (0.26%)

0

Chylous ascites

1 (0.26%)

0

Cuff dehiscence

4 (1.1%)

0

P value

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Total

24/377 (6.4%)

27/131 (20.6%)

⬍ .0001

..............................................................................................................................................................................................................................................

ARF, acute renal failure; DVT/PE, deep venous thrombosis/pulmonary embolus; SBO, small bowel obstruction. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

underutilization of traditional laparoscopy in our subspecialty.5,6 In just 5 years, RS has quickly gained momentum in gynecologic oncology,

and has been rapidly adopted as the preferred MIS platform in our specialty. Both university and private practice– based programs have reported paradigm

TABLE 8

Comparison of major complications in robotic and open endometrial cancer cohorts Complication

Robotic, n ⴝ 377

Open, n ⴝ 131

Cardiac

1 (0.26%)

5 (3.8%)

Pulmonary

3 (0.79%)

1 (0.76%)

DVT/PE

3 (0.79%)

1 (0.76%)

Infectious

4 (1.1%)

6 (4.6%)

ARF/ureteral injury

0

4 (3.0%)

Wound dehiscence/separation

0

9 (6.9%)

Major vessel injury

1 (0.26%)

0

Anemia requiring transfusion

2 (0.53%)

1 (0.76%)

Labile blood sugar

2 (0.53%)

0

Ileus/SBO

2 (0.53%)

0

Cystotomy

1 (0.26%)

0

Chylous ascites

1 (0.26%)

0

Cuff dehiscence

4 (1.1%)

0

P value

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Total

24/377 (6.4%)

27/131 (20.6%)

⬍ .0001

..............................................................................................................................................................................................................................................

ARF, acute renal failure; DVT/PE, deep venous thrombosis/pulmonary embolus; SBO, small bowel obstruction. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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shifts toward MIS that are unprecedented in traditional laparoscopy, despite 2 decades of experience.1,7-10 These trends are not particularly enigmatic given the impact that robotics has already had in urologic surgery, which predated Food and Drug Administration approval for use in gynecology. Furthermore, reports of robotic implementation in gynecology, even at this early phase in its use, suggest decreased surgical morbidity exceeding that reported with traditional laparoscopy.11-17 Motivated by a desire to expand our ability to offer MIS to our patients and to broaden the MIS training of our gynecologic oncology fellows, our group prospectively recorded our experience incorporating robotics into our practice at a metropolitan tertiary care center. Analysis of that first year’s experience demonstrated feasibility of incorporating robotics in our practice with highly acceptable morbidity and favorable conversion rates as compared to those reported with traditional laparoscopy. Given these highly encouraging findings, but recognizing that careful patient selection had been critical to our success, we thought it imperative to continue to analyze clinical outcomes as we expanded this technology to women with more complex clinical problems, as well as those unselected for BMI or previous number of abdominal surgeries. Our findings from our first consecutive 1000 robotic cases suggest that despite a steady, statistically significant rise in average patient BMI, and an increasing proportion of women with medical comorbidities and previous abdominal surgeries, complications rates remained uniformly low. With regard to the entire robotic cohort, conversion rates remained exceeding low despite a rise in average BMI throughout the study interval. In the robotics group overall, a steady decline in vaginal cuff dehiscence rates were seen, despite rising BMI in each subsequent study interval. This decline is likely explained by careful scrutiny of our closure technique with modification to include an interrupted figure-of-eight closure with delayed absorbable 0 polyglyconate suture on a GS-21 needle by the majority of surgeons in our group. In

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www.AJOG.org addition, our postoperative instructions were modified to include pelvic rest until 12 weeks following surgery. Highlighting the impact of these modifications further, is the finding that the only cuff dehiscences after the changes in technique were instituted occurred in patients in whom these guidelines were not employed. The Mayo Clinic reported the incidence of vaginal cuff dehiscence following robotic hysterectomy in 2009.18 At 4 years of experience, the vaginal cuff dehiscence rate was 4.1%. The average time to cuff dehiscence was 6.1 weeks and 57% of cuff dehiscences were associated with a triggering event such as coitus, vaginal brachytherapy, or use of a vaginal dilator. An incidence of cuff dehiscence of 0.6% (current series) to 4.1% is comparable to the reported incidence of cuff dehiscence with laparoscopic hysterectomy at 0.79-4.93%.19,20 The higher vaginal cuff dehiscence rates associated with either MIS technique are likely associated with thermal injury, operative technique, and a faster recovery that encourages patients to return to activities of daily living including intercourse sooner than with laparotomy. Our experience suggests that recognition of the increased risk of cuff dehiscence and subsequent modification of technique can minimize the risk of this complication. Training of gynecologic oncology fellows and residents is an integral part of our program. In a recent survey, 78% of recent gynecologic oncology trainees reported a need for more MIS training.21 Over time, the involvement of residents and particularly fellows on the surgeon console increased. Resident and fellow involvement was not associated with a rise in complications and this is consistent with training in urology programs.22,23 In our institution, a robotic training curriculum has been developed for both residents and fellows that incorporates a process of meeting competency in skill sets in a progressive fashion. Recent advances that have enhanced attending bedside teaching include the telestration and dual-console capabilities. Future advances will include improved simulation platforms. The implementation of robotics in our practice has resulted in a dramatic

TABLE 9

Comparison of complications in robotic and open obese endometrial cohorts (body mass index >30 and <40) Complication

Robotic, n ⴝ 136

Open, n ⴝ 47

Infection

1 (0.7%)

4 (8.5%)

Wound dehiscence/separation

0

5 (10.6%)

Anemia requiring transfusion

1 (0.7%)

1 (2.1%)

Pulmonary

2

1 (2.1%)

Cystotomy

1 (0.7%)

0

Cardiac (MI, Afib)

0

2 (4.2%)

ARF

0

1 (2.1%)

Ureteral injury

0

1 (2.1%)

Total

5 (3.7%)

P value

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

15 (31%)

⬍ .0001

..............................................................................................................................................................................................................................................

Afib, atrial fibrillation; ARF, acute renal failure; MI, myocardial infarction. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

growth in our MIS program overall, but this paradigm shift has been proportionally most significant in our endometrial cancer patients, with a 12.5-fold increase over the study period. This robust paradigm shift to MIS with robotics is consistent with the early experience of others. Holloway et al7 reported a 4- to 5-fold increase in robotic ECS over the first 7 quarters after introduction of this technology. Separate authors described an increase from 5.6-60% in the proportion of women treated with a MIS for ECS in the first year of robotics implementation.10 Our previous analysis suggested that compared with open cases, robotic ECS offered advantages that included decreased EBL and LOS, and a trend toward reduced MC. In that first year, BMI

was significantly lower in the robotics group, attributing to lower operative morbidity in the robotics cohort. Our current analysis of the first 377 robotic ECS suggests that despite no significant differences in the groups with respect to age, BMI, medical comorbidities, or number of previous abdominal surgeries, LN, LOS, and EBL were superior in the RS cohort. Proceeding with RS in women unselected for previous surgery, comorbidities, or BMI did not dilute the benefit of this approach. As opposed to the RS cohort in whom complications were prospectively ascertained, complication rates were abstracted via retrospective review in the laparotomy group. Thus, it is likely that the robotic complication rates are accurate and the open

TABLE 10

Comparison of major complications in robotic and open morbidly obese cohorts (body mass index >40) Complication

Robotic, n ⴝ 53

Open, n ⴝ 23

Wound dehiscence/separation

0

6 (26%)

Infection

3 (5.7%)

2 (8.7%)

ARF

0

2 (8.7%)

Pulmonary

1 (1.9%)

0

DVT/PE

1 (1.9%)

0

Labile BP

1 (1.9%)

0

Total

6 (11.3%)

P value

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

10 (43.5%)

.0006

..............................................................................................................................................................................................................................................

ARF, acute renal failure; BP, blood pressure; DVT/PE, deep venous thrombosis/pulmonary embolus. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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TABLE 11

Vaginal cuff dehiscence in robotic endometrial cancer cohort by year Total EC robotic cases with cuff closure

Year

Cuff dehiscence/ separation, n

Cuff dehiscence/ separation

Mean BMI (kg/m2) ⴞ SD

2006 through 2007

33

1

3.0%

27.2 ⫾ 5.77

2007 through 2008

117

3

2.6%

30.7 ⫾ 8.65

2008 through 2009

197

0

0

32.5 ⫾ 8.12

Total

347

4

1.2%

................................................................................................................................................................................................................................................................................................................................................................................ ................................................................................................................................................................................................................................................................................................................................................................................ ................................................................................................................................................................................................................................................................................................................................................................................ ................................................................................................................................................................................................................................................................................................................................................................................

BMI, body mass index; EC, endometrial cancer. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

TABLE 12

Conversion to laparotomy in robotic endometrial cancer cohort by body mass index category BMI category

n

Total EC patients

Conversions, n

Conversions

Normal weight

93

24.7%

2

2.1%

Overweight

94

24.9%

4

4.2%

138

36.6%

4

2.9%

52

13.8%

3

5.8%

.............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

Obese

..............................................................................................................................................................................................................................................

Morbidly obese

..............................................................................................................................................................................................................................................

BMI, body mass index; EC, endometrial cancer. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

TABLE 13

OT in T1, T2, and T3 for robotic ECS with pelvic and periaortic lymphadenectomy (n ⴝ 109) Year

Range of OT, min

Mean OT, min

Mean node count

2006 through 2007, n ⫽ 20

189–443

304

19.6

2007 through 2008, n ⫽ 29

105–314

230

15.0

2008 through 2009, n ⫽ 60

100–364

207

18.8

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

P values for OT comparisons: T1 vs T2, P ⫽ .019; T1 vs T3, P ⫽ .0001. ECS, endometrial cancer staging; OT, operative times. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

TABLE 14

OT in T1, T2, T3 for robotic ECS with pelvic lymphadenectomy with or without periaortic lymph node sampling (n ⴝ 138) Year

Range of ORT, min

Mean ORT, min

Mean node count (range)

2006 through 2007 (T1), n ⫽ 10

179–275

228

13.1 (2–25)

2007 through 2008 (T2), n ⫽ 28

93–296

190

14.4 (2–45)

2008 through 2009 (T3), n ⫽ 100

78–296

171

12 (5–39)

.............................................................................................................................................................................................................................................. .............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................

P values for ORT comparisons: T1 vs T2, P ⫽ .54; T1 vs T3, P ⫽ .03. ECS, endometrial cancer staging; ORT, operating room times. Paley. Surgical outcomes in gynecologic oncology and robotics. Am J Obstet Gynecol 2011.

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complication rates are underestimated. Others have reported similar reductions in major surgical morbidity in robotics ECS cohorts compared to open ECS and/or laparoscopic cases.9,11,12,16,17,24 These reports, in general, report favorable results with the exception of longer OT. A subset analysis demonstrated a 10fold increase in MC in obese women with open ECS as compared to robotic ECS. Furthermore, women meeting criteria for morbid obesity realized a substantial reduction in MC with RS. Our findings are consistent with other published series in obese women undergoing robotic ECS.25,26 High conversion rates have been an obstacle in widespread use of laparoscopic ECS. In the prospective study of laparoscopy vs laparotomy for ECS conducted by the GOG, the overall conversion rate was 25.8%.4 Conversions from robotic ECS to laparotomy in our series was extremely low (3.5%) and remained low regardless of BMI. Others have reported similarly low conversion rates ranging between 2.812%.7,9,12,15,16 Obesity has been closely correlated with high conversion rates in women undergoing laparoscopic ECS. The GOG study reported that 57.1% of morbidly obese women randomized to laparoscopy required conversion.4 In contrast, we report a conversion rate nearly 10fold lower in our morbidly obese cohort. Other groups have reported similarly favorable completion rates in the morbidly obesepopulationrangingfrom0-15.6%.25,26 A limitation of these series, including our own, is an assessment of how often the planned degree of lymphadenectomy was compromised in favor of avoiding

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www.AJOG.org the morbidity of laparotomy. We are addressing this question in our obese ECS cohort currently. The implications of longer OT are apparent; however, we did see a trend toward improved efficiency with increasing experience despite a significant rise in BMI during each subsequent time interval. Impediments to a steeper decline in OT were the introduction of 2 new attending surgeons in our group and the continual introduction of residents and fellows with an emphasis on increasing fellow console time during the study period. Additional limitations of our series included its retrospective, nonrandomized design potentially introducing selection bias. Strengths of our study included that it is one of the largest robotics gynecologic oncology series to date. Furthermore, the introduction of 2 new attending physicians and incorporation of residents and fellows in RS during the study period likely resulted in an amplification of complications, conversions, and certainly OT as compared to centers with extensive MIS experience in which a core group of attending gynecologic oncologists are performing the procedures. In summary, our single-institution series of the first 1000 consecutive RS procedures performed at a high-volume tertiary care teaching hospital suggests that this approach can be effectively integrated in a gynecologic oncology practice with highly acceptable morbidity and conversion rates. As compared to laparotomy, robotic ECS results in improved clinical outcomes and comparable LN yields. Furthermore, with increasing experience, improved efficiency is seen despite increasing surgical complexity. Further data will be needed to address the questions of long-term clinical outcomes, quality of life outcomes, and cost-effectiveness of RS. f REFERENCES 1. Veljovich DS, Paley PJ, Drescher CW, et al. Robotic surgery in gynecologic oncology: pro-

gram initiation and outcomes after the first year with comparison with laparotomy for endometrial cancer staging. Am J Obstet Gynecol 2008;198:679.e1-10. 2. Childers JM, Surwit EA. Combined laparoscopic and vaginal surgery for the management of two cases of stage I endometrial cancer. Gynecol Oncol 1992;45:46-51. 3. Childers JM, Brzechffa PR, Hatch KD, et al. Laparoscopically assisted surgical staging (LASS) of endometrial cancer. Gynecol Oncol 1993;51:33-8. 4. Walker JL, Piedmonte MR, Spirtos NM, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group study LAP2. J Clin Oncol 2009;27:5331-6. 5. Leiserowitz GS, Xing GB, Parikh-Patel A, et al. Survival of endometrial cancer patients after laparoscopically assisted vaginal hysterectomy or total abdominal hysterectomy: analysis of risk factors. Gynecol Oncol 2007;104(Suppl):A7. 6. Naumann RW, Coleman RL. The use of adjuvant radiation therapy in early endometrial cancer by members of the Society of Gynecologic Oncologists in 2005. Gynecol Oncol 2007; 105:7-12. 7. Holloway RW, Ahmad S, DeNardis SA. Robotic-assisted laparoscopic hysterectomy and lymphadenectomy for endometrial cancer: analysis of surgical performance. Gynecol Oncol 2009;115:447-52. 8. Peiretti M, Zanagnolo V, Bocciolone L, et al. Robotic surgery: changing the surgical approach for endometrial cancer in a referral cancer center. J Minim Invasive Gynecol 2009; 16:427-31. 9. Seamon LG, Cohn DE, Henretta MS, et al. Minimally invasive comprehensive surgical staging for endometrial cancer: robotics or laparoscopy? Gynecol Oncol 2009;133:36-41. 10. Hoekstra AV, Morgan JM, Lurain JR, et al. Robotic surgery in gynecologic oncology: impact of fellowship training. Gynecol Oncol 2009;114:168-72. 11. Cardena-Goicoechea J, Adams S, Bhat SB, et al. Surgical outcomes of robotic-assisted surgical staging for endometrial cancer are equivalent to traditional laparoscopic staging at a minimally invasive surgical center. Gynecol Oncol 2010;117:224-8. 12. Boggess JF, Gehrig PA, Cantrell L. A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy. Am J Obstet Gynecol 2008;199:357.e1-7. 13. Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol 2008;15:286-91.

14. Magrina JF, Kho RM, Weaver AL, et al. Robotic radical hysterectomy: comparison with laparoscopy and laparotomy. Gynecol Oncol 2008;109:86-91. 15. Hoeskstra AN, Jairam-Thodia A, Rademaker A, et al. The impact of robotics on practice management of endometrial cancer: transitioning from traditional surgery. Int J Med Robot 2009;5:392-7. 16. Bell MC, Torgerson J, Seshadri-Kreaden U, et al. Comparison of outcomes and cost for endometrial cancer staging via traditional laparotomy, standard laparoscopy and robotic technique. Gynecol Oncol 2008;111:407-11. 17. Estape R, Lambrou N, Diaz R, et al. A case matched analysis of robotic radical hysterectomy with lymphadenectomy compared with laparoscopy and laparotomy. Gynecol Oncol 2009;133:357-61. 18. Kho RM, Akl MN, Cornellia JL, et al. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol 2009;144:231-5. 19. Hur HC, Guide RS, Mansuria SM, et al. Incidence and patient characteristics of vaginal cuff dehiscence after different modes of hysterectomies. J Minim Invasive Gynecol 2007;14:311-7. 20. Iaco PD, Ceccaroni M, Alboni C, et al. Transvaginal evisceration after hysterectomy: is vaginal cuff closure associated with reduced risk? Eur J Obstet Gynecol Reprod Biol 2006; 125:134-8. 21. Frumovitz M, Soliman PT, Greer M, et al. Laparoscopy training in gynecologic oncology fellowship programs. Gynecol Oncol 2008;111:197-201. 22. Zorn KC, Orvieto MA, Gong EM, et al. Robotic radical prostatectomy learning curve of a fellowship-trained laparoscopic surgeon. J Endourol 2007;21:441-7. 23. Thiel DD, Francis P, Heckman MG, et al. Prospective evaluation of factors affecting operating time in a residency/fellowship program incorporating robot-assisted laparoscopic prostatectomy. J Endourol 2008;22:1331-8. 24. DeNardis SA, Holloway RW, Bigsby GE, et al. Robotically assisted laparoscopic hysterectomy and lymphadenectomy for endometrial cancer. Gynecol Oncol 2008;111:412-7. 25. Seamon LG, Bryant SA, Rheaume PS, et al. Comprehensive surgical staging for endometrial cancer in obese patients. Obstet Gynecol 2009;114:16-21. 26. Gehrig PA, Cantrell LA, Shafer A, et al. What is the optimal minimally invasive surgical procedure for endometrial cancer staging in the obese and morbidly obese woman? Gynecol Oncol 2008;111:41-5.

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