- Email: [email protected]
Robotic-Assisted Gynecologic Surgery and Perioperative Morbidity in Elderly Women
Original Article
Robotic-Assisted Gynecologic Surgery and Perioperative Morbidity in Elderly Women Adrian K. Krause, MD*1, Howard G. Muntz, MD, and Kathryn F. McGonigle, MD From the Women’s Cancer Care of Seattle, Section of Obstetrics and Gynecology, Northwest Hospital & Medical Center, UW Medicine, Seattle, Washington (all authors).
ABSTRACT Study Objective: To assess perioperative complications, conversions, and operative times in patients age R75 years undergoing robotic-assisted gynecologic surgery. Design: Retrospective cohort study (Canadian Task Force classification II-2). Setting: High-volume, 2-physician gynecologic oncology practice. Patients: A total of 705 women who underwent any robot-assisted gynecologic procedure for benign (n 5 380) or malignant (n 5 325) conditions between July 2008 and May 2014. Fifty patients age R75 years (elderly group) were compared with 655 patients age ,75 years (younger group). Interventions: Operative data were gathered prospectively for all robotic-assisted procedures. Demographic and perioperative outcomes were analyzed retrospectively for this study. Measurements and Main Results: The mean age was 81.3 6 4.2 years (range, 75.0–90.5 years) in the elderly group and 52.8 6 11.5 years (range, 22.9–74.6 years) in the younger group. The elderly group had higher rates of surgery for malignancy (90.0% vs 43.2%; p , .01) and lymphadenectomy (44.0% vs 23.4%; p , .01), and was more likely to have cardiovascular disease (88.0% vs 37.6%; p , .01). There were no between-group differences in body mass index or history of chronic obstructive pulmonary disease, diabetes mellitus, or more than 1 previous abdominal surgical procedure. The elderly group was more likely to have a length of stay greater than postoperative day one (30.0% vs 14.8%; p 5 .01) and had a higher incidence of postoperative cardiac arrhythmia (8.0% vs 1.2%; p , .01). The elderly group also had a smaller median uterine size (83.0 6 49.1 g vs 126.0 6 189.5 g; p , .01), but total operative time, rate of conversion (6.0% vs 1.8%) and rate of blood transfusion (2.0% vs 1.5%) were not significantly different between the 2 groups. Rates of bowel and genitourinary injury were ,1% in both groups, and there was no between-group difference in postoperative infectious morbidity, vaginal cuff complications, or reoperation. Conclusion: The perioperative complication rates of robotic-assisted surgery are comparable in elderly women and younger women, despite a longer hospital length of stay and greater likelihood of postoperative arrhythmia in elderly women. Journal of Minimally Invasive Gynecology (2016) 23, 949–953 Ó 2016 AAGL. All rights reserved. Keywords:
Elderly; Laparoscopy; Robotic surgery
The aging population in the United States has led to an increased need for surgical interventions in elderly individuals. Currently, 7% of the United States population is aged The authors declare that they have no conflict of interest. The abstract was presented at the 43rd Global Conference on Minimally Invasive Gynecology, Vancouver, British Columbia. Corresponding author: Adrian K. Krause, MD, 1107 S. Lemay Ave, Ste 101, Fort Collins, CO 80524. E-mail: [email protected] Submitted March 29, 2016. Accepted for publication May 29, 2016. 1
Gynecologic surgical fellow at Women’s Cancer Care of Seattle at the time of data collection; currently practicing at The Women’s Clinic of Northern Colorado. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2016 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2016.05.013
R75 years, and this proportion is expected to rise to 12% by the year 2025 [1]. There is general agreement that age is an independent risk factor for perioperative morbidity and mortality [2–8]. Turretine et al. [2] demonstrated that preexisting comorbidities increase approximately linearly to age 70, but perioperative mortality increases exponentially with each decade of life. Despite these increased risks, however, the overall rate of mortality in gynecologic surgery in elderly women remains acceptably low [3], and thus surgery is a feasible option for this patient population [9–12]. Improved perioperative outcomes have been consistently demonstrated for a laparoscopic approach to gynecologic surgery compared with laparotomy for women of all ages and with all
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Journal of Minimally Invasive Gynecology, Vol 23, No 6, September/October 2016
preexisting comorbidities [13–16]. More recently, roboticassisted laparoscopy has been shown to have comparable outcomes to traditional laparoscopy in the surgical management of endometrial cancer [17,18]. Since the Food and Drug Administration granted approval for gynecologic procedures in 2005, the robotic platform has been increasingly used for gynecologic surgery, despite concerns about added costs and operative time [19–21]. There are little data on the safety of robotic surgery in elderly women, however. These data may be beneficial both for planning surgical procedures and for counseling patients on the risks and benefits of treatment options. The objective of the present study was to compare the overall safety of robotic-assisted gynecologic surgery in elderly women by examining operative statistics and perioperative complication rates in women age R75 compared with those age ,75 years. Methods Study Design and Population Institutional Review Board approval was received to maintain a gynecologic robotic-assisted surgical database. Operative data from 723 consecutive robotic-assisted laparoscopic gynecologic surgery cases from a 2-physician gynecologic oncology practice in Seattle between July 2008 and May 2014 were obtained prospectively by a trained nurse circulator. Patients were evaluated preoperatively by a surgeon, and clinical data were obtained retrospectively by a systematic chart review. A gynecologic surgical fellow was involved in the majority of the surgical cases. Intraoperative data obtained included the procedure performed, total operative time (from incision to closure), time required to complete the hysterectomy portion of the procedure, specimen weight (in grams), pathological diagnosis, total estimated blood loss, and description of any intraoperative conversion to laparotomy or intraoperative injury. Medical records, including hospital charts, outpatient clinical notes,
and any available outside records were reviewed for pertinent data. Eighteen patients were excluded from the analysis because of missing data. The patients were divided into 2 groups based on age at the time of surgical intervention: elderly group (age R75 years) and younger group (age ,75 years). Patient data were extracted, including age (in years), body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), and medical or surgical comorbidities. The outcomes for the 2 groups were then compared with respect to length of stay (LOS), estimated blood loss, use of blood transfusion, operative time, and perioperative surgical complications. Statistical Analysis R version 3.0.2 (R Institute for Statistical Computing, Vienna Austria) was used for computation and analysis. The normality of data was determined using density plots for each of the continuous variables examined. The Student t test was used for continuous variables with a normal distribution (e.g., BMI), the Kruskal-Wallis test of medians was used for skewed distribution data (e.g., estimated blood loss and uterine weight), and Wald survival analysis was used for time variables. Fisher’s exact test or the c2 test, as indicated, was used for analysis of categorical variables. Logistic regression analysis was performed to assess the impact of age and preoperative comorbidities on the likelihood of postoperative cardiac arrhythmia and prolonged LOS. For all tests, a p value of , .05 was considered to indicate significance. Results In this review, a total of 705 patients had available data for analysis, including 50 patients in the elderly group and 655 patients in the younger group. Patient demographic data and comorbid conditions are presented in Table 1. The mean patient age was 81.3 years in the elderly group and 52.8 years
Table 1 Patient demographic data Variable
Elderly cohort (n 5 50)
Young cohort (n 5 655)
p value
Age, yr, mean 6 SD (range) Body mass index, kg/m2, mean 6 SD (range) Comorbidities, n (%) Malignancy* Chronic obstructive pulmonary disease Cardiovascular diseasey Diabetes mellitus .1 abdominal surgery
81.3 6 4.15 (75–90) 30.9 6 6.19 (19.8–45)
52.8 6 11.5 (22.9–74.8) 32.2 6 9.5 (15.4–63.9)
N/A .16
45 (90) 3 (6) 44 (88) 11 (22) 7 (14)
N/A, not applicable. * Preoperative gynecologic malignancy diagnosis. y CVD defined as hypertension, prior myocardial infarction, coronary artery disease or any preexisting arrhythmia.
283 (43) 10 (1.5) 246 (38) 81 (12) 176 (27)
,.01 .06 ,.01 .78 .06
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Table 2 Procedures performed Procedure
Elderly group (n 5 50), n (%)
Young group (n 5 655), n (%)
Hysterectomy 6 salpingo-oophorectomy Hysterectomy and lymphadenectomy Salpingo-oophorectomy or ovarian cystectomy Radical hysterectomy and lymphadenectomy Myomectomy Lymphadenectomy 6 salpingooophorectomy Any lymphadenectomy* Other Conversiony
22 (44) 17 (34) 3 (6)
407 (62.1) 118 (18) 70 (10.7)
.02 .09 .47
3 (6) 0 (0) 2 (4)
21 (3.2) 6 (0.9) 14 (2.1)
.24 .99 .32
22 (44) 0 (0) 3 (6)
153 (23.4) 7 (1.1) 12 (1.8)
p value
,.01 .99 .08
* Includes lymphadenectomy as the sole procedure or in conjunction with other procedures. y Robotic approach converted to laparotomy, traditional laparoscopy, or vaginal surgery.
in the younger group. The elderly patients were significantly more likely than the younger patients to have preexisting cardiovascular disease (88.0% vs 37.6%; p , .01), and to undergo surgery for a malignancy as compared to the younger group (90% vs 43%; p , .01). BMI, the number of previous abdominal surgeries, and rates of comorbidity with chronic obstructive pulmonary disease and diabetes mellitus were not significantly different between the 2 groups. Table 2 describes the types of surgical procedures performed by age group. Overall, 429 (60.9%) hysterectomies with or without removal of adnexa for benign or earlystage endometrial malignancy, 135 (19.1%) hysterectomies with lymphadenectomy for malignancy, and 73 (10.4%) unilateral or bilateral salpingo-oophorectomies or ovarian cystectomies for suspected endometriosis or possible-early stage ovarian malignancy were performed. The remainder of the cases involved radical hysterectomy, myomectomy, or lymphadenectomy alone or with removal of adnexal structures. The elderly patients were more likely than the younger patients to undergo surgery with lymphadenectomy (44.0% vs 23.4%; p , .01). Intraoperative variables in the elderly and younger groups are listed in Table 3. The younger group had a significantly
larger mean uterine size (126 g vs 83 g; p , .01). The 2 groups had comparable operative times, blood loss, and use of blood transfusion. Total operative time is difficult to compare between the 2 groups, given that the elderly patients were more likely to undergo lymphadenectomy. Although not significant, there was a higher rate of conversion to any other surgical approach in the elderly group (6.0% vs 1.8%; p 5 .06). In the elderly group, 2 conversions to laparotomy occurred (4%), 1 for poor visualization in a morbidly obese patient and the other for high-grade ovarian cancer. One unrecoverable instrument failure occurred in this group, after which the case was completed vaginally. In the younger group, there were 11 (1.7%) conversions to laparotomy, including 3 for intraoperative hemorrhage, 6 for poor visualization, 1 for ovarian cancer diagnosis, and 1 for instrument failure. Another case with instrument failure was completed using a standard laparoscopic approach. Of note, all of the instrument failures occurred within the first year after robotic technology was introduced at the hospital. A significantly greater proportion of elderly patients had a hospital LOS past postoperative day one compared with the younger patients (30.0%; range, 2–9 days vs 14.8%; range, 0–10 days; p 5 .01). Within the younger group,
Table 3 Intraoperative variables
Variable
Elderly group n Mean 6 SD
Estimate blood loss, mL Total OR time, min* Hysterectomy time, miny Uterine weight, g
49 35 21 45
59 6 86.79 198 6 88 61 6 26.62 95 6 49.07
* From skin incision to closure. y From division of round ligament to closure of colpotomy.
Range
Young group n Mean 6 SD
0–400 86–385 31–123 46–261
648 453 396 537
65 6 100.62 174 6 70.61 70 6 37.64 184 6 189.47
Range
p value
0–1300 47–509 15–301 24–1532
.28 .06 .17 ,.01
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Table 4 Perioperative complications
Variable Intraoperative complications Conversion* Bowel injury Genitourinary injury Postoperative complications Fever or infection Cystitis Cuff cellulitis Abscess Incisional cellulitis Pneumonia Surgical complications Reoperation Hematomay Urinary retention Cuff dehiscencez Transfusion Medical complications Arrhythmiasx Pulmonary embolus ICU admission
Elderly group (n 5 50), n (%)
Young group (n 5 655), n (%)
3 (6) 0 (0) 0 (0)
12 (1.8) 3 (0.5) 3 (0.5)
.08 .99 .99
1 (2) 1 (2) 0 (0) 1 (2) 0 (0)
14 (2.1) 6 (0.9) 11 (1.7) 20 (3.1) 4 (0.6)
.99 .40 .99 .99 .99
1 (2) 1 (2) 3 (6) 1 (2) 1 (2)
2 (0.3) 4 (0.6) 13 (2) 4 (0.6) 10 (1.5)
.20 .31 .10 .31 .56
4 (8) 0 (0) 2 (4)
8 (1.2) 2 (0.3) 8 (1.2)
,.01 .99 .15
p value
ICU, intensive care unit. * Procedure completed without robotic assistance. y Hematoma at any site, including vaginal cuff, pelvis, and trocar sites. z Requiring surgical repair. x Not diagnosed before surgery.
only 25 patients (3.8%) required a stay beyond postoperative day 2, compared with 6 patients (12.0%) in the elderly group. Table 4 summarizes perioperative complications by age group. Intraoperative complications were uncommon and were not increased in the elderly group. Genitourinary and bowel injury rates were ,1% in each group. There was no patient mortality within 30 days of surgery. There were no between-group differences in the rates of reoperation, intensive care unit (ICU) admission, or postoperative infection. No patient in either group experienced a major cardiac event or myocardial infarction, although several patients developed cardiac arrhythmia during postoperative hospitalization; the rate of arrhythmias was higher in the elderly population (8.0% vs 1.2%; p 5 .01). No patients in the elderly group and only 1 patient in the younger group required cardioversion. On logistic regression analysis, age was the strongest predictor for postoperative arrhythmia. Discussion Based on our experience, patients age R75 years can tolerate a robotic surgical approach with no increase in com-
plications compared with younger patients undergoing comparable procedures. Previous studies also have shown that age alone should not be considered an absolute contraindication to indicated gynecologic surgery. Although postoperative mortality and morbidity do increase with increasing age, the rates of these complications remain acceptably low for gynecologic surgery [3]. In a retrospective study, Scribner et al. [14] found that compared with laparotomy, laparoscopy in elderly patients (age R65 years) was associated with decreased hospital LOS, blood loss, and occurrence of postoperative ileus, and concluded that laparoscopy is the preferred approach whenever feasible. Frey et al. [13], in a small retrospective study of 31 elderly patients (age R65 years) and 36 younger patients undergoing laparoscopic surgery for endometrial cancer, reported no significant between-group differences in the rate of surgical complications, LOS stay, and blood loss. In the present study, there was no difference between the elderly group and younger group in terms of use of blood transfusion, total blood loss, operative time, intraoperative injury, infectious morbidity, ICU admission, and reoperation. A significantly higher proportion of elderly patients were diagnosed with a new cardiac arrhythmia of any type, yet invasive intervention or ICU admission for arrhythmia was not more likely in the elderly group. A significantly higher proportion of elderly patients required a postoperative stay past postoperative day 1. During the study period, it was standard practice to discharge a patient on postoperative day 1 after roboticassisted hysterectomy, myomectomy, or lymph node dissection, or on postoperative day 0 if only adnexal surgery was performed. The majority of elderly patients requiring a longer than standard stay were discharged on postoperative day 2 without an associated increase in morbidity. Furthermore, the average LOS was still considerably less than expected had the patients undergone laparotomy. Elderly patients had a longer LOS stay if they required prolonged monitoring for medical comorbidities such as arrhythmia. In addition, there was likely a lower threshold for continued observation in the elderly patients, to ensure safety in ambulation and the transition to home care postoperatively. This study has several limitations. As a nonrandomized retrospective study, there may be selection bias because the surgeon chose the operative technique for each patient. We believe that this bias is minimal, however, given that the elderly and younger patients were preoperatively evaluated in a standard fashion. Age was not considered a contraindication for robotic surgery within the practice, and thus a different treatment plan would have been chosen only for patients who had a severe medical comorbidity that precluded robotic surgery. No patient was excluded by the anesthesiologist from a robotic approach at the time of surgery due to such comorbidities as extreme obesity with concurrent poor pulmonary function. A retrospective chart review also could result in underreporting of postoperative complications or adverse events.
Krause et al.
Robotic-Assisted Gynecologic Surgery and Perioperative Morbidity in Elderly Women
In conclusion, in this study the rate of complications associated with robotic-assisted gynecologic surgery was not greater in elderly women compared with younger women. This result was observed despite the greater number of comorbidities and greater likelihood of a cancer diagnosis in the elderly group. A robotic surgical approach was achieved in almost all patients. Therefore, whenever feasible, the benefits of a minimally invasive approach should be offered to eligible patients regardless of age. References 1. US Census Bureau, Population Division. Projections of the population by sex and age for the United States: 2015-2060. Available at: http://www.census.gov/population/projections/data/national/2014/ summarytables.html; 2014. Accessed June 12, 2016. 2. Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006;203: 865–877. 3. Sung VW, Weitzen S, Sokol ER, Rardin CR, Myers DL. Effect of patient age on increasing morbidity and mortality following urogynecologic surgery. Am J Obstet Gynecol. 2006;194:1411–1417. 4. Hamel MB, Henderson WG, Khuri SF, Daley J. Surgical outcomes for patients aged 80 and older: morbidity and mortality from major noncardiac surgery. J Am Geriatr Soc. 2005;53:424–429. 5. Sgarbura O, Tomulescu V, Blajut C, Popescu I. A 5-year perspective over robotic general surgery: indications, risk factors, and learning curves. Chirurgia (Bucur). 2013;108:599–610. 6. Sultana JC, Campbell JW, Pisanelli WS, Sivinski L, Rimm AA. Morbidity and mortality of incontinence surgery in elderly women: an analysis of Medicare data. Am J Obstet Gynecol. 1997;176:344–348. 7. Stepp KJ, Barber MD, Yoo EH, Whiteside JL, Paraiso MF, Walters MD. Incidence of perioperative complications of urogynecologic surgery in elderly women. Am J Obstet Gynecol. 2005;192:1630–1636. 8. Choi DK, Lee IG, Hwang JH. Arterial to end-tidal carbon dioxide pressure gradient increases with age in the steep Trendelenburg position with pneumoperitoneum. Korean J Anesthesiol. 2012;63:209–215. 9. Shuster PA, Barter JF, Potkul RK, Barnes WA, Delgado G. Radical hysterectomy morbidity in relation to age. Obstet Gynecol. 1991;78:77–79.
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10. Susini T, Scambia G, Margariti PA, et al. Gynecologic oncologic surgery in the elderly: a retrospective analysis of 213 patients. Gynecol Oncol. 1999;75:437–443. 11. Lawton FG, Hacker NF. Surgery for invasive gynecologic cancer in the elderly female population. Obstet Gynecol. 1990;76:287–289. 12. Parker DY, Burke JJ 2nd, Gallup DG. Gynecological surgery in octogenarians and nonagenarians. Am J Obstet Gynecol. 2004;190: 1401–1403. 13. Frey MK, Ihnow SB, Worley MJ Jr, et al. Minimally invasive staging of endometrial cancer is feasible and safe in elderly women. J Minim Invasive Gynecol. 2011;18:200–204. 14. Scribner DR Jr, Walker JL, Johnson GA, McMeekin SD, Gold MA, Mannel RS. Surgical management of early-stage endometrial cancer in the elderly: is laparoscopy feasible? Gynecol Oncol. 2001;83: 563–568. 15. Ciavattini A, Di Giuseppe J, Cecchi S, et al. Gynecologic laparoscopy in patients aged 65 or more: feasibility and safety in the presence of increased comorbidity. Eur J Obstet Gynecol Reprod Biol. 2014;175: 49–53. 16. Wright JD, Neugut AI, Wilde ET, Buono DL, Tsai WY, Hershman DL. Use and benefits of laparoscopic hysterectomy for stage I endometrial cancer among Medicare beneficiaries. J Oncol Pract. 2012;8:e89–99. 17. Gaia G, Holloway RW, Santoro L, Ahmad S, Di Silverio E, Spinillo A. Robotic-assisted hysterectomy for endometrial cancer compared with traditional laparoscopic and laparotomy approaches: a systematic review. Obstet Gynecol. 2010;116:1422–1431. 18. 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;15:286–291. 19. Lavoue V, Zeng X, Lau S, et al. Impact of robotics on the outcome of elderly patients with endometrial cancer. Gynecol Oncol. 2014;133: 556–562. 20. Lau S, Vaknin Z, Ramana-Kumar AV, Halliday D, Franco EL, Gotlieb WH. Outcomes and cost comparisons after introducing a robotics program for endometrial cancer surgery. Obstet Gynecol. 2012; 119:717–724. 21. Leitao MM Jr, Bartashnik A, Wagner I, et al. Cost-effectiveness analysis of robotically assisted laparoscopy for newly diagnosed uterine cancers. Obstet Gynecol. 2014;123:1031–1037.
Robotic-Assisted Gynecologic Surgery and Perioperative Morbidity in Elderly Women Adrian K. Krause, MD*1, Howard G. Muntz, MD, and Kathryn F. McGonigle, MD From the Women’s Cancer Care of Seattle, Section of Obstetrics and Gynecology, Northwest Hospital & Medical Center, UW Medicine, Seattle, Washington (all authors).
ABSTRACT Study Objective: To assess perioperative complications, conversions, and operative times in patients age R75 years undergoing robotic-assisted gynecologic surgery. Design: Retrospective cohort study (Canadian Task Force classification II-2). Setting: High-volume, 2-physician gynecologic oncology practice. Patients: A total of 705 women who underwent any robot-assisted gynecologic procedure for benign (n 5 380) or malignant (n 5 325) conditions between July 2008 and May 2014. Fifty patients age R75 years (elderly group) were compared with 655 patients age ,75 years (younger group). Interventions: Operative data were gathered prospectively for all robotic-assisted procedures. Demographic and perioperative outcomes were analyzed retrospectively for this study. Measurements and Main Results: The mean age was 81.3 6 4.2 years (range, 75.0–90.5 years) in the elderly group and 52.8 6 11.5 years (range, 22.9–74.6 years) in the younger group. The elderly group had higher rates of surgery for malignancy (90.0% vs 43.2%; p , .01) and lymphadenectomy (44.0% vs 23.4%; p , .01), and was more likely to have cardiovascular disease (88.0% vs 37.6%; p , .01). There were no between-group differences in body mass index or history of chronic obstructive pulmonary disease, diabetes mellitus, or more than 1 previous abdominal surgical procedure. The elderly group was more likely to have a length of stay greater than postoperative day one (30.0% vs 14.8%; p 5 .01) and had a higher incidence of postoperative cardiac arrhythmia (8.0% vs 1.2%; p , .01). The elderly group also had a smaller median uterine size (83.0 6 49.1 g vs 126.0 6 189.5 g; p , .01), but total operative time, rate of conversion (6.0% vs 1.8%) and rate of blood transfusion (2.0% vs 1.5%) were not significantly different between the 2 groups. Rates of bowel and genitourinary injury were ,1% in both groups, and there was no between-group difference in postoperative infectious morbidity, vaginal cuff complications, or reoperation. Conclusion: The perioperative complication rates of robotic-assisted surgery are comparable in elderly women and younger women, despite a longer hospital length of stay and greater likelihood of postoperative arrhythmia in elderly women. Journal of Minimally Invasive Gynecology (2016) 23, 949–953 Ó 2016 AAGL. All rights reserved. Keywords:
Elderly; Laparoscopy; Robotic surgery
The aging population in the United States has led to an increased need for surgical interventions in elderly individuals. Currently, 7% of the United States population is aged The authors declare that they have no conflict of interest. The abstract was presented at the 43rd Global Conference on Minimally Invasive Gynecology, Vancouver, British Columbia. Corresponding author: Adrian K. Krause, MD, 1107 S. Lemay Ave, Ste 101, Fort Collins, CO 80524. E-mail: [email protected] Submitted March 29, 2016. Accepted for publication May 29, 2016. 1
Gynecologic surgical fellow at Women’s Cancer Care of Seattle at the time of data collection; currently practicing at The Women’s Clinic of Northern Colorado. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2016 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2016.05.013
R75 years, and this proportion is expected to rise to 12% by the year 2025 [1]. There is general agreement that age is an independent risk factor for perioperative morbidity and mortality [2–8]. Turretine et al. [2] demonstrated that preexisting comorbidities increase approximately linearly to age 70, but perioperative mortality increases exponentially with each decade of life. Despite these increased risks, however, the overall rate of mortality in gynecologic surgery in elderly women remains acceptably low [3], and thus surgery is a feasible option for this patient population [9–12]. Improved perioperative outcomes have been consistently demonstrated for a laparoscopic approach to gynecologic surgery compared with laparotomy for women of all ages and with all
950
Journal of Minimally Invasive Gynecology, Vol 23, No 6, September/October 2016
preexisting comorbidities [13–16]. More recently, roboticassisted laparoscopy has been shown to have comparable outcomes to traditional laparoscopy in the surgical management of endometrial cancer [17,18]. Since the Food and Drug Administration granted approval for gynecologic procedures in 2005, the robotic platform has been increasingly used for gynecologic surgery, despite concerns about added costs and operative time [19–21]. There are little data on the safety of robotic surgery in elderly women, however. These data may be beneficial both for planning surgical procedures and for counseling patients on the risks and benefits of treatment options. The objective of the present study was to compare the overall safety of robotic-assisted gynecologic surgery in elderly women by examining operative statistics and perioperative complication rates in women age R75 compared with those age ,75 years. Methods Study Design and Population Institutional Review Board approval was received to maintain a gynecologic robotic-assisted surgical database. Operative data from 723 consecutive robotic-assisted laparoscopic gynecologic surgery cases from a 2-physician gynecologic oncology practice in Seattle between July 2008 and May 2014 were obtained prospectively by a trained nurse circulator. Patients were evaluated preoperatively by a surgeon, and clinical data were obtained retrospectively by a systematic chart review. A gynecologic surgical fellow was involved in the majority of the surgical cases. Intraoperative data obtained included the procedure performed, total operative time (from incision to closure), time required to complete the hysterectomy portion of the procedure, specimen weight (in grams), pathological diagnosis, total estimated blood loss, and description of any intraoperative conversion to laparotomy or intraoperative injury. Medical records, including hospital charts, outpatient clinical notes,
and any available outside records were reviewed for pertinent data. Eighteen patients were excluded from the analysis because of missing data. The patients were divided into 2 groups based on age at the time of surgical intervention: elderly group (age R75 years) and younger group (age ,75 years). Patient data were extracted, including age (in years), body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), and medical or surgical comorbidities. The outcomes for the 2 groups were then compared with respect to length of stay (LOS), estimated blood loss, use of blood transfusion, operative time, and perioperative surgical complications. Statistical Analysis R version 3.0.2 (R Institute for Statistical Computing, Vienna Austria) was used for computation and analysis. The normality of data was determined using density plots for each of the continuous variables examined. The Student t test was used for continuous variables with a normal distribution (e.g., BMI), the Kruskal-Wallis test of medians was used for skewed distribution data (e.g., estimated blood loss and uterine weight), and Wald survival analysis was used for time variables. Fisher’s exact test or the c2 test, as indicated, was used for analysis of categorical variables. Logistic regression analysis was performed to assess the impact of age and preoperative comorbidities on the likelihood of postoperative cardiac arrhythmia and prolonged LOS. For all tests, a p value of , .05 was considered to indicate significance. Results In this review, a total of 705 patients had available data for analysis, including 50 patients in the elderly group and 655 patients in the younger group. Patient demographic data and comorbid conditions are presented in Table 1. The mean patient age was 81.3 years in the elderly group and 52.8 years
Table 1 Patient demographic data Variable
Elderly cohort (n 5 50)
Young cohort (n 5 655)
p value
Age, yr, mean 6 SD (range) Body mass index, kg/m2, mean 6 SD (range) Comorbidities, n (%) Malignancy* Chronic obstructive pulmonary disease Cardiovascular diseasey Diabetes mellitus .1 abdominal surgery
81.3 6 4.15 (75–90) 30.9 6 6.19 (19.8–45)
52.8 6 11.5 (22.9–74.8) 32.2 6 9.5 (15.4–63.9)
N/A .16
45 (90) 3 (6) 44 (88) 11 (22) 7 (14)
N/A, not applicable. * Preoperative gynecologic malignancy diagnosis. y CVD defined as hypertension, prior myocardial infarction, coronary artery disease or any preexisting arrhythmia.
283 (43) 10 (1.5) 246 (38) 81 (12) 176 (27)
,.01 .06 ,.01 .78 .06
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Table 2 Procedures performed Procedure
Elderly group (n 5 50), n (%)
Young group (n 5 655), n (%)
Hysterectomy 6 salpingo-oophorectomy Hysterectomy and lymphadenectomy Salpingo-oophorectomy or ovarian cystectomy Radical hysterectomy and lymphadenectomy Myomectomy Lymphadenectomy 6 salpingooophorectomy Any lymphadenectomy* Other Conversiony
22 (44) 17 (34) 3 (6)
407 (62.1) 118 (18) 70 (10.7)
.02 .09 .47
3 (6) 0 (0) 2 (4)
21 (3.2) 6 (0.9) 14 (2.1)
.24 .99 .32
22 (44) 0 (0) 3 (6)
153 (23.4) 7 (1.1) 12 (1.8)
p value
,.01 .99 .08
* Includes lymphadenectomy as the sole procedure or in conjunction with other procedures. y Robotic approach converted to laparotomy, traditional laparoscopy, or vaginal surgery.
in the younger group. The elderly patients were significantly more likely than the younger patients to have preexisting cardiovascular disease (88.0% vs 37.6%; p , .01), and to undergo surgery for a malignancy as compared to the younger group (90% vs 43%; p , .01). BMI, the number of previous abdominal surgeries, and rates of comorbidity with chronic obstructive pulmonary disease and diabetes mellitus were not significantly different between the 2 groups. Table 2 describes the types of surgical procedures performed by age group. Overall, 429 (60.9%) hysterectomies with or without removal of adnexa for benign or earlystage endometrial malignancy, 135 (19.1%) hysterectomies with lymphadenectomy for malignancy, and 73 (10.4%) unilateral or bilateral salpingo-oophorectomies or ovarian cystectomies for suspected endometriosis or possible-early stage ovarian malignancy were performed. The remainder of the cases involved radical hysterectomy, myomectomy, or lymphadenectomy alone or with removal of adnexal structures. The elderly patients were more likely than the younger patients to undergo surgery with lymphadenectomy (44.0% vs 23.4%; p , .01). Intraoperative variables in the elderly and younger groups are listed in Table 3. The younger group had a significantly
larger mean uterine size (126 g vs 83 g; p , .01). The 2 groups had comparable operative times, blood loss, and use of blood transfusion. Total operative time is difficult to compare between the 2 groups, given that the elderly patients were more likely to undergo lymphadenectomy. Although not significant, there was a higher rate of conversion to any other surgical approach in the elderly group (6.0% vs 1.8%; p 5 .06). In the elderly group, 2 conversions to laparotomy occurred (4%), 1 for poor visualization in a morbidly obese patient and the other for high-grade ovarian cancer. One unrecoverable instrument failure occurred in this group, after which the case was completed vaginally. In the younger group, there were 11 (1.7%) conversions to laparotomy, including 3 for intraoperative hemorrhage, 6 for poor visualization, 1 for ovarian cancer diagnosis, and 1 for instrument failure. Another case with instrument failure was completed using a standard laparoscopic approach. Of note, all of the instrument failures occurred within the first year after robotic technology was introduced at the hospital. A significantly greater proportion of elderly patients had a hospital LOS past postoperative day one compared with the younger patients (30.0%; range, 2–9 days vs 14.8%; range, 0–10 days; p 5 .01). Within the younger group,
Table 3 Intraoperative variables
Variable
Elderly group n Mean 6 SD
Estimate blood loss, mL Total OR time, min* Hysterectomy time, miny Uterine weight, g
49 35 21 45
59 6 86.79 198 6 88 61 6 26.62 95 6 49.07
* From skin incision to closure. y From division of round ligament to closure of colpotomy.
Range
Young group n Mean 6 SD
0–400 86–385 31–123 46–261
648 453 396 537
65 6 100.62 174 6 70.61 70 6 37.64 184 6 189.47
Range
p value
0–1300 47–509 15–301 24–1532
.28 .06 .17 ,.01
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Journal of Minimally Invasive Gynecology, Vol 23, No 6, September/October 2016
Table 4 Perioperative complications
Variable Intraoperative complications Conversion* Bowel injury Genitourinary injury Postoperative complications Fever or infection Cystitis Cuff cellulitis Abscess Incisional cellulitis Pneumonia Surgical complications Reoperation Hematomay Urinary retention Cuff dehiscencez Transfusion Medical complications Arrhythmiasx Pulmonary embolus ICU admission
Elderly group (n 5 50), n (%)
Young group (n 5 655), n (%)
3 (6) 0 (0) 0 (0)
12 (1.8) 3 (0.5) 3 (0.5)
.08 .99 .99
1 (2) 1 (2) 0 (0) 1 (2) 0 (0)
14 (2.1) 6 (0.9) 11 (1.7) 20 (3.1) 4 (0.6)
.99 .40 .99 .99 .99
1 (2) 1 (2) 3 (6) 1 (2) 1 (2)
2 (0.3) 4 (0.6) 13 (2) 4 (0.6) 10 (1.5)
.20 .31 .10 .31 .56
4 (8) 0 (0) 2 (4)
8 (1.2) 2 (0.3) 8 (1.2)
,.01 .99 .15
p value
ICU, intensive care unit. * Procedure completed without robotic assistance. y Hematoma at any site, including vaginal cuff, pelvis, and trocar sites. z Requiring surgical repair. x Not diagnosed before surgery.
only 25 patients (3.8%) required a stay beyond postoperative day 2, compared with 6 patients (12.0%) in the elderly group. Table 4 summarizes perioperative complications by age group. Intraoperative complications were uncommon and were not increased in the elderly group. Genitourinary and bowel injury rates were ,1% in each group. There was no patient mortality within 30 days of surgery. There were no between-group differences in the rates of reoperation, intensive care unit (ICU) admission, or postoperative infection. No patient in either group experienced a major cardiac event or myocardial infarction, although several patients developed cardiac arrhythmia during postoperative hospitalization; the rate of arrhythmias was higher in the elderly population (8.0% vs 1.2%; p 5 .01). No patients in the elderly group and only 1 patient in the younger group required cardioversion. On logistic regression analysis, age was the strongest predictor for postoperative arrhythmia. Discussion Based on our experience, patients age R75 years can tolerate a robotic surgical approach with no increase in com-
plications compared with younger patients undergoing comparable procedures. Previous studies also have shown that age alone should not be considered an absolute contraindication to indicated gynecologic surgery. Although postoperative mortality and morbidity do increase with increasing age, the rates of these complications remain acceptably low for gynecologic surgery [3]. In a retrospective study, Scribner et al. [14] found that compared with laparotomy, laparoscopy in elderly patients (age R65 years) was associated with decreased hospital LOS, blood loss, and occurrence of postoperative ileus, and concluded that laparoscopy is the preferred approach whenever feasible. Frey et al. [13], in a small retrospective study of 31 elderly patients (age R65 years) and 36 younger patients undergoing laparoscopic surgery for endometrial cancer, reported no significant between-group differences in the rate of surgical complications, LOS stay, and blood loss. In the present study, there was no difference between the elderly group and younger group in terms of use of blood transfusion, total blood loss, operative time, intraoperative injury, infectious morbidity, ICU admission, and reoperation. A significantly higher proportion of elderly patients were diagnosed with a new cardiac arrhythmia of any type, yet invasive intervention or ICU admission for arrhythmia was not more likely in the elderly group. A significantly higher proportion of elderly patients required a postoperative stay past postoperative day 1. During the study period, it was standard practice to discharge a patient on postoperative day 1 after roboticassisted hysterectomy, myomectomy, or lymph node dissection, or on postoperative day 0 if only adnexal surgery was performed. The majority of elderly patients requiring a longer than standard stay were discharged on postoperative day 2 without an associated increase in morbidity. Furthermore, the average LOS was still considerably less than expected had the patients undergone laparotomy. Elderly patients had a longer LOS stay if they required prolonged monitoring for medical comorbidities such as arrhythmia. In addition, there was likely a lower threshold for continued observation in the elderly patients, to ensure safety in ambulation and the transition to home care postoperatively. This study has several limitations. As a nonrandomized retrospective study, there may be selection bias because the surgeon chose the operative technique for each patient. We believe that this bias is minimal, however, given that the elderly and younger patients were preoperatively evaluated in a standard fashion. Age was not considered a contraindication for robotic surgery within the practice, and thus a different treatment plan would have been chosen only for patients who had a severe medical comorbidity that precluded robotic surgery. No patient was excluded by the anesthesiologist from a robotic approach at the time of surgery due to such comorbidities as extreme obesity with concurrent poor pulmonary function. A retrospective chart review also could result in underreporting of postoperative complications or adverse events.
Krause et al.
Robotic-Assisted Gynecologic Surgery and Perioperative Morbidity in Elderly Women
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